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University of Utah Huntsman Institute Clinical trial

foamhand
Posts: 68
Joined: May 2016

Well, maybe some good news. My oncologist called and after consulting with her partner, she said I am such low volume spread that it may not yet be time for chemo and that lupron and casodex may be enough now. She is also going to refer me to The Huntsman Cancer Institute at the University of Utah for a clinical trial of a promising new drug. I told her to go ahead and get me referred. Maybe some good news finally. I'm cautiously optimistic.

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VascodaGama
Posts: 2873
Joined: Nov 2010

Foam,

These are good news. Clinical trials are safe, one is well looked after and all the monitoring (tests, etc) is free of charge. The only worry is if they group you into the cohort not getting the "special" drug. You should be assured that you will use that drug, not only the hormonal treatment.

Typicaly most of the participants in these type of trials need to be free from chemo. That could be the reason for your oncologist to change his initial protocol (HT+Chemo).

Please let us know details of the trial.

Your story is here: https://csn.cancer.org/node/302660

A link about Trials at Utah;

http://healthcare.utah.edu/clinicaltrials/participation.php

Best wishes,

VG 

receiving  

 

foamhand
Posts: 68
Joined: May 2016

Thanks for the info. I will be sure to tell them I want to be getting the drug. Since I'm taking Casodex, the oncologist says there's no rush yet to start lupron until we see about the clinical trial so apparently the Casodex is at least slowing things down

Max Former Hodgkins Stage 3's picture
Max Former Hodg...
Posts: 3084
Joined: May 2012

Did your oncologist decide that radiation would not be a good idea ?

foamhand
Posts: 68
Joined: May 2016

They are saying I'm in a grey area right now and have put off further treatment except Casodex so they don't disqualify me from the clinical trial. I asked about radiation and they said the bone mets are really small and they are not causing me any pain so for now it's not needed. Chemo is the preferred treatment for the lymph nodes she said but with only 1-2 nodes involved, the risks of chemo are greater than benefit at this time. They are even holding off on a bone biopsy until I'm screened for the trials. I asked about continued spread and she said the Casodex should keep things in check for a month or so while I get tested for the trials. They do want the Lupron treatment but I can't take it prior to being accepted for the clinical trial as that would disqualify me. She said I most likely will get the Lupron in addition to the new drug being tested and Huntsman will pay for it.

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VascodaGama
Posts: 2873
Joined: Nov 2010

Foamhand,

Prostatic cells survive in “diets” of androgens. ADT stands for Androgen Deprivation Therapy. If we manage to stop feeding it or provide something similar but fake (like Casodex), then the cancer dies of starvation or becomes dormant (inactive) for long periods of time.
Casodex is an antiandrogen made up of a similar bio-structure to testosterone which will fake the cancerous cells into absorbing it. Once staked to cell’s AR androgen receptors (mouth of cancer), it does not allow absorption of the real stuff. This works well in most types of PCa (there are about 25 types of prostate cancer) that depend on testosterone to survive. In your next PSA test you can verify about your type. Lower values will mean that the cancer is responding to the therapy (testosterone dependent).

Lupron (LHRH agonist) works differently than Casodex. Lupron “causes” the testicles to stop producing the testosterone. It affects the pituitary so that this will stop sending orders/signals down for “manufacture” of androgens. Without testosterone in circulation (chemical castration status) the cancer starves and dies or starts feeding in other androgens produced by other endocrine glands (adrenal, thyroid, etc). These exist and correspond to about 5% of circulating androgens in our body.

The above two drugs (modalities) are usually taken solo or together to strike a bigger blow to the cancer. However, these do not kill the cancer totally and the bandit will find ways to “survive”, even by starting to produce its own androgens or AR mutation (Darwin principle of species adaptation and survival). The process may take years to occur and meanwhile one may die of other causes.

Many other drugs used in ADT will work to interfere with androgen production at all levels. 5-ARI such as Finasteride or CYP17 inhibitors like Zytiga (abiraterone acetate) or Ketokonazole, are used together with the above or reserved for later attack (second line ADT) when patient becomes refractory to antiandrogens. This is a never ending story. Chemo would kill the cancer (destroy its DNA) but it would affect benign cells too, so that it cannot be administered at its full strength.

In view of the above and your doctor’s “relaxed” comment of “…such low volume spread…”, I wonder why haven’t he consider an attack with radiation (Max also opinions this above). I believe that he is not sure to the extent of cancer spread. Please reread my previous comment to you;
https://csn.cancer.org/comment/1542725#comment-1542725

Can you share details of the exams (bone scan and image study). What have they found and it is written in the reports?

Regarding the trial, you should get the name of the drug (or type of trial) to verify the benefits that such will bring to you and in regards to the side effects it may cause. You should also question about the negative points that such drug may take in future therapies (in case it becomes necessary to you).

I would advise you to collect and file copies of all data because you will have different physicians caring along your journey. Reliable information is crucial in the decisions ahead.

Best,

VG

 

foamhand
Posts: 68
Joined: May 2016

Thanks Vgama...(you can read my reply to Max for more info) I will try to get more info on my tests. I go for an upper body CT scan Monday to check lungs etc. I've never smoked and doctors have said I sound clear except for the expected noise from mild asthma that comes and goes but I figure it's good to get the CT scan anyway.

I am slightly suspicious what the rush is to get me into a clinical trial is. I know Lupron is extremely expensive, and am wondering if my employer insurance is giving them an issue about paying for it, hence the suggestion for a clinical trial where I would get my meds paid for. I will be asking the doctor this on Tuesday.

As far as the Trial, it is overseen by a Dr. Agarwal at Huntsman Institute, and they show his specialty in solid tumor research which seems curious as my cancer has left the prostate. However, They are specialist doctors and know tons more than I do about my disease so they must have good reasons for considering me.

foamhand

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VascodaGama
Posts: 2873
Joined: Nov 2010

There is a Portuguese quote that I would like to tell you in English but do not know how to translate. It simple means to "Be inquisitive, use wisdom and ask".

Not even your doctor expects you to know everything but if suspicious about his intent then ask till you get a satisfying answer. I do not think that he is rushing you to the trial. I guess that he just wants to start a therapy the soonest and without assurances of "someone to pay" then he is looking for possibilities. It is wise to be accompanied by a family member and take notes when visiting for consultations. Use diplomacy when inquiring.

You can ask details of the trial. Which drug is used, the purposes and the duration of the trial. Also about the monitoring after the trial; is it included? Are all tests free of charge?

I believe the situation made you anxious. You are dealing with the unknown and, still worse, without assurances of an insurance to pay the costs. This is pretty bad. You need help on the matter and the best way is to visit your local health authorities. I think that any hospital can give you information on how to proceed. Your doctor is one of the sources but you should get a second opinion from others. Getting involved in the trial may solve the payment of Lupron but it may not include future treatments.

In this pharmaceutical link they inform about the "Patient Assistance Programs for Lupron Depot-PED". They may have a similar program for chemo, etc. Call them and get informed on how to be involved;

http://www.drugs.com/price-guide/lupron-depot-ped

The upper body CT scan is important. It will check the lungs and the upper body's lymph nodes. What about a DEXA scan to verify bone loss? This is also important for patients recommended to chemotherapies. Ask your doctor to include the test.

Regarding Dr. Agarwal, he is famous at ASCO. He is a researcher to SWOG programs therefore someone to trust when dealing with an advanced case. I do not know if you have met him already but he also can help you understanding things on the trial. SWOG is a famous in running PCa trials since 2009. They have one that concerns the hormonal therapy in stage IV patients. I wonder if this is the trial you have been suggested?
This trial does not include any “newer” drug but simple tests in Stage IV patients the traditional ADT drugs (LHRH agonist and Antiandrogen) administered solo or combined against a placebo cohort, also done to verify continuous administration against intermittent.
Here are details; https://clinicaltrials.gov/ct2/show/NCT00002651

You can read their controversial findings in this interim report of 2011;
http://jco.ascopubs.org/content/early/2011/04/18/JCO.2010.32.2776.full.pdf

In any case, SWOG has done many trials using several medications including the famous chemo drugs Docetaxel and Estramustine, with confirmed results that may be the actual choice of your doctor to treat you. Ask him the name of the “special”. Dr. Agarwal knows about all the trials and their results. He can provide you peace of mind. Trust him but get the drug. Do not become a member of the placebo group.

Best wishes,

VGama

 

foamhand
Posts: 68
Joined: May 2016

I'm not sure I understand how the trial works, but from what I've read elsewhere, if it is a "blind" study, then do I get a chance to decide which group I get in? According to the Huntsman Institute site, random selection is part of the process. If I'm not going to know wether or not I get the drug, it may not be worth the travel time and expense, and another solution will have to be found.

I will ask questions at the meeting with the oncologist on Tuesday. As I've said before, As long as I feel able to work, I want to continue to do so, however, since my oncologist says I probably automatically qualify for disability at this point with the metastasis, if getting payment for medical care would be better on disability and medicaid in order to prolong my life, I will quit my job and apply.

I know that presents a whole new set of issues, but with today's insane costs of medical care and the deceptive loophole seeking insurance companies, I will do what I have to do to get care.

foamhand
Posts: 68
Joined: May 2016

I have found the following notes:

 " The patient comes in today with his wife to discuss his recent diagnosis of prostate cancer. ?He had a PSA of 7.1 an abnormal digital rectal exam. ?Prostate ultrasound and biopsy revealed a Gleason 9 adenocarcinoma involving all 12 cores. ?His prostate MRI revealed PI-RADS 5 changes within the prostate as well as pelvic adenopathy and an enhancing lesion in the right femoral neck consistent with metastatic disease. ?CT scan of the abdomen and pelvis confirmed retroperitoneal adenopathy. ?Bone scan also confirmed the finding of the lesion the right femoral neck. ?The CT did not show the lesion in the right femur but the MRI apparently is much more sensitive and reliable in making the diagnosis of bone metastases."

And also...

"Note: I had a discussion with the patient and his wife regarding his diagnosis. ?Unfortunately appears that he has metastatic prostate cancer. ?He has metastases to pelvic lymph nodes as well as the right femur. ?He is not symptomatic from his bone metastases. ?His biggest complaints right now are of urinary obstruction. ?He is worried that he will go into retention.

I explained that he is not a candidate for localized treatment such as radiation therapy or radical prostatectomy. ?This gentleman need systemic therapy and his best option would be androgen deprivation combined with chemotherapy. ?I contacted oncology and discussed this with him. ?Referral will be made to... ?I will go ahead and start the patient on Casodex and Lupron.

Because of his severe lower urinary tract symptoms I think he will need a channeling TURP. ?I did explain that with androgen deprivation his prostate would shrink it may take several months for that to happen. ?The patient felt that he really cannot wait because his symptoms are so severe."

 

I had the TURP which helped immensely but still do not have any painful symptoms of metastasis. I am on Casodex and await screening for Clinical Trial before starting Lupron.

foamhand

 

 

 

 

 

 

 

foamhand
Posts: 68
Joined: May 2016

Just met with local oncologist and her team conferred again and said just Lupron for now with no chemo is the best recommended course as there's minimal spread and chemo risks may not be warranted yet. The Huntsman clinical trials as far as my oncologist knew was a 2 to 1 ratio of drug vs placebo administration so my odds are a little better at 66.6% of getting the drug. If Dr. Agarwal decides I'm a candidate, I will go for it. I will get my lupron as part of standard therapy anyway in addition to the test med, so I think it's worth a monthly trip to Salt Lake City.  I will update next week upon my return from Huntsman with the info from Dr. Agarwal.

Max Former Hodgkins Stage 3's picture
Max Former Hodg...
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Foamhand,

Your doctor's notes are certainly well detailed. It answers the question I had regarding radiation very clearly.  Postponing chemo until essential is a good idea, as chemo applied to metastatic PCa is palliative, not curative.  Don't use it until necessary, as it is harsh (probably beginning with Taxotere, but that most likely is years away).

You seem to have a very good medical team. Hormonal Therapy often keeps the disease beaten back for many, many years.

max

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VascodaGama
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Joined: Nov 2010

Thanks for sharing the Notes. I hope you get the answers from Dr. Argarwal in regards to the trial. Name, purposes, duration and list of exams and tests included. I also would request they check/include the testosterone before administration of Lupron, or have it done localy before travelling.

Have a good trip.

Best wishes,

VG

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VascodaGama
Posts: 2873
Joined: Nov 2010

Foamhand,

I think it better for you to continue our exchanged opinions about the trial in this thread (if you want). Nobody would understand your comment in the other newer thread without the contents of this one.

Here is a copy of your information on the trial:

"Well, I Met Dr. Agarwal and I like him. He doesn't pull punches and is direct and a very sharp doctor. The drug is TAK-700 but I can't go into too much detail as when I tried to give details and post, I got locked out and re-directed to a IT security link saying to contact them, so all I will say is Dr. Agarwal is trying to improve hormone therapy with this new drug that is more of a targeted attack, and he prefers this to chemo which is more like dropping a nuclear bomb on the cancer. I have a few more tests to pass before being accepted, but so far things look good."

I wonder if you were told details regarding this trial of Orteronel (TAK 700). Is it new?

As far as I know, this drug's phase III trial started in 2010 for metastatic castration-resistant prostate cancer and it was terminated by its owner Takeda Pharmaceutical in 2014, without receiving FDA's approval for its use in PCa. The reason for termination was that the results did not demonstrate significant improvement in extending life, when compared to the placebo group.

The trial was done worldwide in two characteristics groups, with chemo naive patients and none chemo naive patients. Here are details of the trial;

https://clinicaltrials.gov/ct2/show/NCT00569153

Here are the results;

http://www.esmo.org/Conferences/Past-Conferences/European-Cancer-Congress-2015/News/Anti-tumour-Activity-Demonstrated-with-Orteronel-in-Metastatic-Castration-Resistant-Prostate-Cancer

ASCO Journal also published the abstract of the trial findings written by the researchers, including the name of Dr. Argawal. Here is

http://jco.ascopubs.org/content/early/2015/01/23/JCO.2014.56.5119

In any case, these researchers found that Orteronel demonstrated to be effective in inhibiting the manufacture of androgens when in comparison with the placebo drugs. However, patients on Orteronel experienced more side effects than the placebo group.

A similar drug is Zytiga (abiraterone acetate). Its trial results do not differ much from Orteronel. Both are 17-lyase inhibitors (slightly different) and used to attack cancer’s intratumoral activity when it becomes resistant to traditional antiandrogens (such as Casodex). Zytiga was FDA approved for stage IV patients. Another similar drug (P450 inhibitor) and cheaper is Ketoconasol, used for many years by oncologists to fight castration registant PCa.

Probably Dr. Argawal wants you to take Orteronel as a substitute of Casodex but will you keep Lupron (?).

Please let us know details as you move forward.

Best wishes,

VGama

 

Old Salt
Posts: 721
Joined: Aug 2014

I am surprised that trials with TAK-700 are ongoing since Takeda has stopped development of the drug. Moreover, as Vasco pointed out, the drug failed in an important earlier trial. And, relevant to Dr Agarwal's trial discussed in this thread, there are significant side effects.

I hate to rain on your parade, but please be aware that a trial is just that. A positive outcome is by no means guaranteed.

I still wish that the drug would help you personally, even when the overall outcome of the trial may not be successful. But be aware of the side effects that have been identified in the earlier (failed) trial.

foamhand
Posts: 68
Joined: May 2016

The original TAK-700 trial was using it solo from what I understand, not in conjunction with Lupron. Takeda quit making it but another company, Millenium Pharmaceuticals has picked it up. As I mentioned in my later posts, this is a trial of combination use and DR. Agarwal says he has good success with many on the ongoing combo therapy with 3 years and counting of 0.0 PSA.

I know my cancer can no longer be cured (yet) but if newer therapies can buy me many more years, why not try it.  Thanks for your interest and concern. It is appreciated.

Old Salt
Posts: 721
Joined: Aug 2014

There are examples in oncology where drugs have been 'repurposed' into useful treatments. Let's hope for such an outcome.

foamhand
Posts: 68
Joined: May 2016

The trial is Oteronel vs Casodex in conjunction with the lupron. Zometa will also be used to strengthen bone as I have a small bone met.  He wants to delay chemo as long as possible in my case with localized spread. he stated that Casodex is a 35 yr old drug and If successful, The TAK-700 combo with lupron may behave more like Xtandi which is a $15,000 drug and which is not usually accepted as a first line drug for Pca.

 

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VascodaGama
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I cross my fingers for your success in the trial. Surely it will be better that you fall into the group of patients taking Orteronel. Bicalutamide (Casodex) is a cheap and easy to take pill (you are already experiencing) but it is not recommended as a solo androgen blokage in risky cases because it only addresses the AR androgen receptors (mouth) of cancerous cells. It works well initialy but after a long period of use (years) the cancer modifies its AR and starts feeding on the Casodex itself.

Enzalutamide (Xtandi) has greater affinity for cell's androgen receptor than bicalutamide prolonging the time of dependency in an ADT treatment but it also fails and it is much more expensive. Dr. Argawal was involved in a trial comparing Xandi agaisnt Casodex.
http://jco.ascopubs.org/content/34/18/2098.full?related-urls=yes&legid=jco;34/18/2098

This time your trial may be similar to the above using Orteronel instead. However, Orteronel is not an antiandrogen like Casodex or Xtandi. Probably the trial intent is to verify if stage IV patients have higher benefit by starting the hormonal treatment with CYP 17 inhibitors, which typically are given only after the patient becomes refractory.
Hormonal therapies weaken the bone so that they will include Zometa to avoid bone reabsorption. This drug may cause hypercalcemia. Chek your lipids timely. 

Thinking of you,

Best

VG

foamhand
Posts: 68
Joined: May 2016

Hi all, still awaiting acceptance to the trial but should have an answer by next week. Had to have additional tests done, upper body CT scan, echocardiogram & EKG to check lungs / heart. Lungs showed clear and heart function was very good with just one small valve seep that I was told was normal for asthmatics who use inhalers and it was not a big worry. Also had a bone DEXA scan since they plan on using Zometa as well. Huntsman called me yesterday and said their clinical trials panel was going over all my tests and would have them prepared for Dr. Agarwal to look at on Tuesday 7/5/16. The nurse said so far my numbers all looked within range. I should know by the end of next week and I will report back.

foamhand.

foamhand
Posts: 68
Joined: May 2016

Hi all, got the acceptance call today and was told that the randomization computer picked me to get the study drug TAK-700 with Lupron , not the standard bicalutimide and Lupron combination so I guess all the time and tests were worth it. I go to Huntsman Monday 6/11 to start therapy. My GP doctor saw me monday and did a PSA, it's dropped a little from 7.1 to 6.8 so maybe the bicalutimide is helping some, but I know there are always some fluctuaions in PSA in general.  I will post once I've been in therapy a bit to report my progress, side effects etc.

foamhand

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VascodaGama
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I am glad for the news. The lower PSA is due to the bicalutamide, but it will serve as the reference marker to compare Orteronal success.You should keep a copy of all tests (lipids, DEXA, etc) for future comparisom.
I still recommend you to get a testosterone "marker" before starting Lupron. Discuss the matter with your doctor or do it yourself at a local laboratory or hospital. This is a cheap test done with a simple blood sample and such wouldn't interfere with the trial requirements.

Please let us know the details including info about restrictions, such as diets, when (time) to take the drug, its dose and the milestones for checking progress, etc. Surely the goal will be to arrest the bandit and keep it on the canvas KO for many years. I whish you success.

VG 

foamhand
Posts: 68
Joined: May 2016

Dr. Agarwal just called and said he is concerned that my prostate may enlarge in a year or so even with the hormone therapy, counteracting the benefit of my TURP procedure, and he said he wants me to get radiation now just to the prostate to prevent enlargment. He said since radiation is needed I have to get it within the first 4 months of his therapy or else he has to take me off the TAK-700 to do radiation. He said the radiation is 10 sessions of low dose which should not exhibit any side effects, and would take only 2 weeks.

On a positive note, (he said he couldn't tell me this prior to being selected for the trial to keep from creating any bias in my mind if I were in the standard therapy group) but so far he has good success with patients getting the TAK-700 / Lupron combo. 3 years after therapy PSA levels for many are still 0.0.

Will update again after returning from Huntsman on Mon.

foamhand
Posts: 68
Joined: May 2016

Well Back from HCI and on Lupron and TAK-700. Baseline PSA 5.2 (down from 6.8 1 week ago.) So far, no side effects other than a little fatigue. No dietary restrictions other than cut out as much sugar as possible, and just a moderation based balanced diet recommended. No Tobacco...a given. Calcium and Vitamin D3 daily. Zometa will start in 1 month after a dental checkup. Radiation consult happening today and will probably begin in a week or so.

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VascodaGama
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Now you are at peace. Somehow when at the begining of a treatment we have that feeling of accomplishment. Then we become curious when the first results are out. And then there will be the time we worry about any success (Is it enough? did I managed to kill it?).

Regarding the added radiation, I do not understand the logic in having it to decrease the prostate size. Better if it included a full dose to kill the cancer too. I would recommend you to get a copy of the planning/field/scope because it may influence possibilities of any future attack to treat a recurrence. Rads over rads is not recommended if the applied dose reaches the limits of tissue's absorption, and radiation would be your prefered salvage therapy.

Best wishes for success.

VG

   

foamhand
Posts: 68
Joined: May 2016

Met the radiation oncologist today. He is a little curious about the limited rads ordered as well and explained the difficulty of future rads, but apparently it has to do with the parameters of the clinical trial. Apparently there is a protocol to be followed to stay qualified. He is going to consult with the lead radiation oncologist at Huntsman who has treated people in the same clinical trial as I am in to see what the logic and procedure is. They probably want to be sure that improvement from the drug cannot be confused with improvement from the radiation. I will let you know.

 

foamhand
Posts: 68
Joined: May 2016

Yes, limiting radiation to the prostate only is a requirment for the trial. Dr. Agarwal said if my Pca returns it most likely will start back in the prostate again so the rads are preventative. Otherwise, he is confident my trial drug combo will do the job for now and hopefully many years.

Minor side effects noted as of Thursday....fatigue / some dizziness, annoying but not debilitating and comes and goes. No hot flashes yet. some moodiness but short lived. When they subside, I feel good. It's early yet but hopefully I will have full awareness of all side effects by the time my second Lupron shot is due in 3 months. I guess I will let things ride for now, and will post again in a few months after rads and my next visit to Huntsman. If anything major shows up I'll post it here.  Best wishes to all.

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VascodaGama
Posts: 2873
Joined: Nov 2010

The best way to counter the effects from the hormonal therapy is by changing the life style (afternoon naps, earlier dinners, etc.), involving in a fitness program (walking 5 Km a day intermmitently, golf on weekends, showvel snow, attending a gym, etc) and changing diets. Here are some tips you can try;

http://cancer.ucsf.edu/_docs/crc/nutrition_prostate.pdf

Best,

VG 

foamhand
Posts: 68
Joined: May 2016

Had the second consult with radiation oncologist and he was still against doing the short course of radiation to the prostate primarily due to the fact that I've had a TURP and show no more severe urinary restrictions. The premise of doing the radiation for urinary relief was actually a way of trying to gain more control against a re-activation of cancer in the prostate and thereby increasing the chances of success in the trial. The reason used for the radiation had to be carefully worded as to not disqualify me from the trial, so treatment of urinary symptoms was legit for the trial while actually doing the radiation to go directly after the cancer in the prostate would disqualify me.

The radiation oncologist said since I've had the TURP there were two possible severe complications that could arise by doing the radiation. 1.- urethral stricture, which basically meant swelling / scar tissue buildup constricting the urethra thereby undoing the benefit of the TURP. I would basically be back in the same boat as before having the TURP. He said this would go away over time but it didn't make sense possibly undoing my current relief. 2.- urethral necrosis where the urethral tissue would die / decay therefore possibly requiring surgery to rectify. He called Dr. Agarwal and apparently with the further consideration of things they agreed to not do rads now. If down the road radiation became necessary, I could still have it, but this would most likely mean the trial is failing for me and I would have to be taken off the study anyway.

So just HT for now. Side effects are worse on some days and almost non existant on other days but so far nothing I can't push through. Fatigue and hot flashes / cold sweats with some random moderate aches and pains in the joints / lower back which are listed side effects. The hardest part for me now is the dietary changes. I hate giving up my donuts and pastries...lol. Best to all and I will update in a month or so after my next clinic visit.

foamhand

 

foamhand
Posts: 68
Joined: May 2016

Lupron with TAK-700 combo seems to be working. PSA down from 5.2 to 3.1 in a month. Testosterone level <3.0...almost all shut down. Side effects are a hassle but I manage to push thru and still work. Other blood work all in normal range for my condition. Discussed starting Effexor but was asked to wait if possible until my 2nd lupron injection to see if my system will adjust at all on it's own. Hot flashes are moderate to strong and irritability on the rise some.(thank gosh for understanding co-workers...lol.) Fatigue has been mitigated by adjusting the times I take my TAK-700 to the least physically demanding times of my day. Improving on my diet....much more fruit and veggies, less sugar and processed foods. And the saga continues...

foamhand

 

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VascodaGama
Posts: 2873
Joined: Nov 2010

Congratulations. So far you are the winner. Lower PSA (meaning a control on the cancer) and accommodated life style in spite of the treatment side effects. The lower testosterone (castrate levels) also verifies the success of the therapy in knocking down the cancer. I would substitute any pill (antidepressant) by a series of physical exercises. Daily walks and aerobics are known to counter depressive moods.

Best wishes for still lower PSA.

VG

foamhand
Posts: 68
Joined: May 2016

Hi VG, The Effexor is to reduce hot flashes, not necessarily for depression although maybe an added benefit. I guess the Effexor has an effect on the brain's temperature regulator, supporting it in the absence of testosterone. They said they would prefer to use it rather than progesterone (Megastrol) It doesn't eliminate them but studies show a 50%+ reduction in hot flashes in men.

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VascodaGama
Posts: 2873
Joined: Nov 2010

Thanks for the info. I usually try first stress physical exercises instead of pills. It has worked for me for the hot flashes. The worse side effect from leuprolide was fatigue and lost of libido. I managed to get into sex but the willingness wasn't there. Mood changes occured at the two months period, then gone.

Best wishes,

foamhand
Posts: 68
Joined: May 2016

Thanks, VG. At my job I get quite a bit of walking / lifting exercise. I make Almond Toffee with a one of a kind toffee making machine here in Colorado USA. The candy line is about 75ft long one way and makes a U-turn back so I repeatedly walk (a fast walk) 150ft or so several times an hour for 6-8 hours each day. I also have to load the machine with butter which comes in 55 lb. blocks and I have to lift, unwrap and load 2 of them into the machine every 15-20 min. for 4-6 hours of my day. I also climb up and down a 8ft ladder several times an hour to check part of the machine. I walk my dog twice a day on weekends for about a mile each time and it's a brisk walk as my dog is high energy. I feel I am reasonably active. My main concern is being cordial with my co-workers during hot flashes which also trigger mood swings. The women seem to understand...lol. Hopefully this will subside or can be dealt with by the Effexor.

One concern was raised at Huntsman during my last checkup...I mentioned I was lifting those large blocks of butter and the clinician, (a nurse / practicioner under Dr. Agarwal, not the doc himself) said lifting those large blocks was more than he would like to see me lift, but he did not say I couldn't do it. I hope this doesn't present a problem with my work in the near future. I expect to have to go on disability eventually but would like to get in a few more years working if possible. Anyway, I'm just taking it one day at a time for now. I'll report again after Sept. 12th visit to Huntsman. Take care.

 

foamhand
Posts: 68
Joined: May 2016

Back from Huntsman and so far PSA still dropping. went from 3.1 to 1.5 in a month. Hot flashes still there but seem to be getting a little further apart. Started .5mg Ativan for sleep problems(waking every 2 hours at night) My clinician has ordered a follow-up metabolic panel as one of my liver enzyme levels seems to have spiked some. He said this is normal with the Lupron / Bicalutimide combo but it's not supposed to happen with the lupron / TAK-700 combo. Hopefully it was just an isolated incident, so I'll retest by thursday. other than that,  I'm just plugging along.

foamhand

VascodaGama's picture
VascodaGama
Posts: 2873
Joined: Nov 2010

Wonderful news. The drop in PSA signifies success at the many fronts. One should note that you have the prostate still in place, most probably whole infected. At biopsy it was found with cancer allover (all 12 needles 100% positive Gleason s9) in addition to the metastases to bone and lymph nodes.
The report is here: https://csn.cancer.org/node/302660 

The drop tells us that the cancer (or part of it) is hormone dependent providing the possibility for a series of attacks with a line of HT drugs, reserving radiation for a later attack. I hope it continues that way but do not be alarmed if the PSA never reaches the 0.0 mark. One aspect of Gleason patern 4 and 5 (Gs9 patients) is that these cells produce little amounts of PSA serum and some do not produce it at all. These make the PSA unpractical as a solo mark to judge progress. Any small variation is important as well as any symptom or variation in lipids. You need to be vigilant but should enjoy life fully.

Let's celebrate the drop. How about a glass of Colorado Bulldog? Make it with two parts of vodka for me.

Best,

VG

foamhand
Posts: 68
Joined: May 2016

I've discovered a new favorite libation (enjoyed on rare occasions only of course) Considering I'm under full time influence of Lupron, this drink sounded quite appropriate...it's called "Angry Balls".  It's a glass of "Angry Orchard" apple flavored ale with a shot of "Fireball" cinnamon whiskey. Tastes like cinnamon apple, but kicks like a boilermaker...lol. Thanks for your reply VG.

foamhand
Posts: 68
Joined: May 2016

Just returned from my last visit from Huntsman and PSA drop wasn't nearly as dramatic as previous visits. Went from 1.5 to just a 1.2,(maybe due to my still having my cancerous prostate) but they were satisfied and said as long as it doesn't start upward again I'm OK. They have switched me from monthly visits to 3 month visits since I need Lupron shots every 3 months and to get re-supplied with my TAK-700. Hot flashes have intensified somewhat with my second Lupron shot, (they were getting a little better) but hopefully they will settle down again.

Liver toxicity has dropped, ALT down from 172 to 66. Culprit seemed to be a multi-vitamin that was too much for my liver, and not the TAK-700.

So far still a success. I will report if anything changes and check in occasionally. 

Hope everyone on here is having personal success of their own.

foamhand.

foamhand
Posts: 68
Joined: May 2016

As of 1/9/2017, Lupron and TAK-700 trial still working good. PSA down to 1.0, my latest blood work shows all within normal range. Effexor XR 75mg daily has reduced my hot flashes by 70%. Getting Zometa every 3 months when I return to Huntsman for more Lupron / Tak-700. Still pain free except for normal aging aches and pains that come and go. Ibuprofen is all I need for pains. Still working and life is good. Hope everyone is having their own success with beating back this crud.

foamhand.

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GeneRose1
Posts: 64
Joined: Aug 2016

Foamhand, VDG, and Old Salt, thanks so much for this thread. Knowledge is power & this really helps.

foamhand
Posts: 68
Joined: May 2016

Things are still going well. April 10th checkup at Huntsman Cancer Institute showing a 0.6 PSA. I'm a little anxious about the next visit in July as it will be time again for the full battery of scans...Dexa, CT, MRI etc. This will show if the bone met went away and if the cancer is still shut down and not spreading. Being Gleason 9 and Stage 4 locally advanced, their is a little worry,  but it will be what it will be. I am still working full time thankfully and the insurance has been pretty good. Huntsman has also helped out financially so I am still living pretty comfortably for a blue collar worker.

The Effexor is still helping hot flashes about 50%, but my job is quite active and I have started to have some minor memory problems and an increase of fatigue due to the ADT. My general doctor has allowed me to try a low dose (5mg) of Adderal...(an amphetamine). I know I need to be very careful with this as it is an addictive drug but it is a very low dose. Huntsman has approved this as well. The first few days seem to be ok. I have a noticeable increase in awareness and energy in the morning but it doesn't last all day. I'm back to being very tired the last 2-3 hours of my shift. I am going to adjust the timing of the Adderal to see if it will help. If I need to increase dosage I will only go up one more level to 10 mg. If that doesn't work, I will have to try something else. Some  ADHD patients go as high as 60 mg but I think that would really cause me problems.  Still no real pain other than normal aches and pains that come with getting older.

Overall, life is good right now, and I hope this trial works for many more years.  I will report back after my scans in July to let everyone know how it went.

All my best to everyone on here.

Foamhand.

hopeful and opt...
Posts: 2218
Joined: Apr 2009

Wonderful to read that you are doing well. 

Will toast to your success

Best to you

H

 

 

Old Salt
Posts: 721
Joined: Aug 2014

Great to read that there are no major complications up to this point. You deserve it because you did put a lot of thought and effort getting into this trial.

Thanks for the update.

As an aside, do you bring toffee to the Huntsman staff to keep them focussed and happy?

VascodaGama's picture
VascodaGama
Posts: 2873
Joined: Nov 2010

I am really happy for your bravery and success. I want to thank you for continuing reporting on your developments and results. This thread will help the many confronting similar situations. Those following your story should read the above posts taking into consideration the dates of the posts for consistency on the discussions.

Congratulations for still a lower PSA. You have enter into the remission level. This is attributed to your case because you got your prostate in place., however, such doesn't mean that you are cancer free. I hope the scans are trustful and provide a better guess on the remission.
I would like to know about the DEXA results. What was your base data? Any apparent osteopenia?

As discussed before I am against the pills (Adderal) you've start taking, suggesting you to give preferences of a change in life style (lunch naps and less lifting of the "butter blocks", and brainy exercises similar to Sudoku may substitute the pill in mental affinity). But your team of doctors has shown to be highly proficient on your course and medical needs, nailing all the aspects till today. Just be careful and continue checking the lipids and all other blood panels, in particular those related to kidney function (clearance in urine 24H test).

Best,

VG

foamhand
Posts: 68
Joined: May 2016

Latest trip to Huntsman Cancer Institute for one year progress assessment. New CT and bone scans. results are as follows:

IMAGING:  (Obtained 07/11/2017)
1.  Abdomen/pelvis CT with contrast:  Impression shows improvement in the previously seen adenopathy. No new nodes. Significant decrease in the size of the prostate gland. Liver cysts with new tiny hypodensities too small to characterize. 1.2 cm sclerotic lesion within the right femur.
2.  Whole body bone scan:  Impression shows new areas of increased MDP uptake in the right posterior ninth and left sixth rib concerning for disease progression.
 
These lab reports and scan reports were reviewed with patient. Scans also independently reviewed in the clinic.
 
ASSESSMENT: (foamhand) a 56-year-old male, with metastatic prostate cancer.  Prostate biopsy performed on 05/23/2016 showed bilateral adenocarcinoma, Gleason 4+5 equals 9 disease.  A prostate MRI performed on 05/17/2016 showed metastatic bilateral iliac lymphadenopathy and right femoral osseous metastatic lesion.  Bicalutamide started on 06/07/2016. Bicalutamide therapy discontinued on 07/10/2016.  Treated with SWOG 1216 protocol treatment, randomized to ADT plus TAK-700 arm, beginning 07/11/2016.    
 
Today, in addition to history of hormone sensitive metastatic adenocarcinoma of the prostate, the patient has the following clinical manifestations:  Intermittent fatigue, intermittent reflux, intermittent shortness of breath with exertion, intermittent insomnia, intermittent flu-like symptoms, intermittent constipation, intermittent pain (primarily polyarthralgias, pelvis and neck), intermittent nocturia and intermittent cramping in the calves at night.  All symptoms are longstanding and stable, except mildly palpable left axillary lymph node.  We discussed that he continue to monitor for enlargement.  For further details regarding treatment-related adverse events and attributions, please see documentation in the medical record dated 07/11/2017.  We reviewed the PSA, which is stable at 0.6 ng/mL.  We discussed his restaging scans from yesterday showing improved lymphadenopathy, but new osseous rib lesions.  We discussed that rib lesions could represent flare response, especially with PSA decreasing and lymph node improvement.   We reviewed the PSA, which is stable at 0.6 ng/mL. We discussed plan to repeat bone scan in 3 months.
 
When i first met with Dr. Agarwal, he hadn't seen the bone scan yet so when I read about the ribs I got worried and called. They are pretty sure it is a "flare effect" but I will do another bone scan in October. I am very happy with all the shrinkage of the soft tissue and no soft tissue spread. Dr. Agarwal said we will stay the course until my PSA rises to a 3. Then we will do a short course of Chemo as he said it works very well on the early resistant cells. Hopefully this is still a long way off. My lipids all show good and standard CBC only has a few catagories out of range and they are only a little low or high, nothing of a real concern.
 
We did make the zoo and Lagoon amusement park in Salt Lake City this trip so overall it was a good trip.
 
Plowing along with hope and positive attitude.
 
foamhand
 
VascodaGama's picture
VascodaGama
Posts: 2873
Joined: Nov 2010

I am with you. I read your report and my concern goes to the tiny liver cysts. Both doctors gave an opinion on the ribs justifying the findings as "flares" without significance. I wonder if they know about your job lifting 55 lb. butter blocks. The lesions at the ribs (6th and 9th close to shoulders) could have something to do with your work and behind the scan findings. The 1.2 cm sclerotic lesion at the right femur was there from the beginning. You could inquire if it has decreased when comparing with the previous scan.

This is your first anniversary of the successful therapy with a good outcome in shrinking metastases that are confirmed by a decreasing PSA from 4.6 to 0.6 ng/ml. According to your report, Agarwal has establish the threshold PSA=3.0 ng/ml as the end of the treatment. However, he also commented on the possibility of adding chemo to the protocol, and my lay opinion is that you should give it a try. The present ADT will not be effective forever. Chemo will give you the opportunity of eliminating the bandit. In any case, adding chemo means adding side effects to the existing ones. You need to be prepared for the influence it may have in your professional life.

The cysts at the liver must be rechecked. PCa in the liver would not be a favorable finding and the CT is not much reliable when detecting small size tumours. I believe that Dr. Agarwal can include in the trial a PET scan with 18F choline, which would provide a more precise conclusion on the disease progression/regression. The PSA of 0.6 is still within the parameters for detection so that you could comment on the exam in your next meeting/conversation.

Best wishes for better results and enjoyment (I would like to presence one day one of those famous speed races at the lake).

VG

foamhand
Posts: 68
Joined: May 2016

I submitted my questions to Dr. Agarwal about the liver and my work requirments. I missed his return call but he did leave a message stating that due to my excellent response to the therapy he saw no need to change anything at this time. I hope to discuss things further with him on my October visit.

foamhand

foamhand
Posts: 68
Joined: May 2016

6 week interval blood draw shows PSA down from 0.6 to 0.5. Maybe it isn't done dropping yet. Fingers crossed.

foamhand.

 

 

foamhand
Posts: 68
Joined: May 2016

Well, good news and some concerning news. The good news, My Oct 9th follow up bone scan showed no new bone metastasis, supporting Dr. Agarwal's belief that the later bone mets were flare effect. The concerning thing to me is that now I've learned there is a small lesion on my right Tibia. It seems there was more bone spread than I was originally aware of. I am wondering if the bone scans are somewhat of an imperfect tool or if there could be that much difference between radiologists interpretations of scans? 

The APRN under Dr. Agarwal still assures me I'm doing great and the only pain I have is in areas that so far show free of cancer, so probably side effect related.

Still doing well mentally as what else can I do but continue on as positively as I can. Worry or fretting doesn't help and would most likely hurt my overall health.

My best to all, hope everyone is having some success.

foamhand.

Old Salt
Posts: 721
Joined: Aug 2014

Thanks again for reporting back to us. More importantly, it was good to read that Dr A thinks that you are doing well. 

VascodaGama's picture
VascodaGama
Posts: 2873
Joined: Nov 2010

Hi again,

I believe in both your comments regarding the CT capabilities, in both the machine  and the interpretation of the findings. It is always better to get second opinions. In any case if such hidden metastases exist the treatment would not be different from what you do now. Resent radiopharmaceuticals have shown better and more accurate results in PET scans identifying cancer lessons in bone.

Lesions at the tibia are common in particular in Soccer players. It could be from a past occurrence you do not recall. It is good to have realistic details but at it's own timing. Be aware that ADT can lead you to worry about unimportant trivials.

Best wishes for continuing success.

VG

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