University of Utah Huntsman Institute TAK-700 Clinical trial

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Comments

  • foamhand
    foamhand Member Posts: 93
    Old Salt said:

    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.

    TAK-700

    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
    Old Salt Member Posts: 899 Member
    foamhand said:

    TAK-700

    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.

    Yes

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

  • foamhand
    foamhand Member Posts: 93
    Update

    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.

  • VascodaGama
    VascodaGama Member Posts: 3,491 Member
    edited July 2016 #25
    Rads over rads is complicated

    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
    foamhand Member Posts: 93

    Rads over rads is complicated

    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

       

    Still conferring

    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
    foamhand Member Posts: 93
    edited July 2016 #27
    Summary...

    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.

  • VascodaGama
    VascodaGama Member Posts: 3,491 Member
    Life style change to counter the effects

    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
    foamhand Member Posts: 93
    edited July 2016 #29
    Rads nixed after all...

    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
    foamhand Member Posts: 93
    back from 2nd checkup...

    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

     

  • VascodaGama
    VascodaGama Member Posts: 3,491 Member
    edited August 2016 #31
    Congratulations

    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
    foamhand Member Posts: 93
    edited August 2016 #32

    Congratulations

    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

    Effexor not for depression...

    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.

  • VascodaGama
    VascodaGama Member Posts: 3,491 Member
    edited August 2016 #33
    Stressful exercises was good for me

    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
    foamhand Member Posts: 93

    Stressful exercises was good for me

    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,

    Thanks.

    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
    foamhand Member Posts: 93
    edited September 2016 #35
    Latest Update...

    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
    VascodaGama Member Posts: 3,491 Member
    Plugging along

    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
    foamhand Member Posts: 93
    Let's try a different drink....

    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
    foamhand Member Posts: 93
    edited October 2016 #38
    Update...

    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
    foamhand Member Posts: 93
    Latest Update

    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.

  • GeneRose1
    GeneRose1 Member Posts: 64
    This is a fascinating thread

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

  • foamhand
    foamhand Member Posts: 93
    Checking in...

    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.