University of Utah Huntsman Institute TAK-700 Clinical trial

foamhand
foamhand Member Posts: 93
edited November 2020 in Prostate Cancer #1

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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Comments

  • VascodaGama
    VascodaGama Member Posts: 3,501 Member
    Clinical Trial

    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
    foamhand Member Posts: 93
    edited June 2016 #3
    Thanks VGama

    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
    Max Former Hodgkins Stage 3 Member Posts: 3,725 Member
    Rads

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

  • VascodaGama
    VascodaGama Member Posts: 3,501 Member
    edited June 2016 #5
    Mechanics behind Hormonal Treatments (ADT)

    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
    foamhand Member Posts: 93

    Rads

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

    Not yet time.

    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.

  • foamhand
    foamhand Member Posts: 93
    Suspicions...

    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

  • VascodaGama
    VascodaGama Member Posts: 3,501 Member
    edited June 2016 #8
    "Quem tem Boca vai a Roma"

    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
    foamhand Member Posts: 93
    Thanks.

    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
    foamhand Member Posts: 93
    Notes for For VGama and Max

    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
    foamhand Member Posts: 93
    Update

    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
    Max Former Hodgkins Stage 3 Member Posts: 3,725 Member
    Assessment

    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

  • VascodaGama
    VascodaGama Member Posts: 3,501 Member
    Talk about the Testosterone test

    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

  • VascodaGama
    VascodaGama Member Posts: 3,501 Member
    Orteronel (TAK 700)

    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

     

  • foamhand
    foamhand Member Posts: 93
    You are correct.

    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.

     

  • VascodaGama
    VascodaGama Member Posts: 3,501 Member
    edited June 2016 #16
    Orteronel vs Casodex in conjunction with Lupron

    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
    foamhand Member Posts: 93
    Update

    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
    foamhand Member Posts: 93
    Accepted To Clinical Trial / Getting TAK-700

    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

  • VascodaGama
    VascodaGama Member Posts: 3,501 Member
    Good News

    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
    foamhand Member Posts: 93
    Now Adding Radiation...

    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.

  • Old Salt
    Old Salt Member Posts: 910 Member

    Orteronel (TAK 700)

    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

     

    Pessimistic about TAK-700

    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.