TAK-700

[Don1157]

I am making a decision to enter a clinical trial for TAK-700 (orteronel), anybody had an experience with a clinical trial for this drug?

[JoelT]

Can't say that I have any direct experience with this trial, but I would like to thank you for considering a trial.  Trials help us make advances and they also give a person access to a cutting edge treatment that otherwise would not be available.

Joel

[Don1157 in reply to JoelT]

Newly diagnosed with metastatic PC, one rib involvement. It's kinda scary when I read the list the side effects, but a chance at more than standard treatment is welcome. So I think we will try. My oncologist is well respected in the KC area, and he said I was a good candidate. Could have had the rib treated with radiation, but the radiation oncologist said it would only delay the inevitable, ADT. He did my initial radiation treatment. Super nice guy, real human in his interaction. Both arms of the trial involve Lupron, so there is a 50/50 chance of being in the experimental group.

[JoelT]

Don,

Your comment leads me to assume that your goal is to avoid ADT.  Check very carefully because I am not sure that the TAK-700 trial you are thinking about will accomplish your goal.  I am aware of only onr active trial that is currently recruiting for prostate cancer.  It is the:

S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer (S1216)

This trial uses ADT drugs along with TAK-700.  According to the clinical trials web site the two trial arms are:

1-   Experimental: ADT + TAK-700

LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months along with TAK-700 (Orteronel), 300 mg, PO, twice daily.

 

Compared to

2-  ADT + Bicalutamide

LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.

and

Bicalutamide (Casodex), 50 mg, PO, q daily

My understanding is that this trial requires both arms to be on ADT.

If you are hoping to avoid ADT (which will probably not be reasonable over the long haul) this trial will not be to your liking.  Clarify with your doctor this information.  Maybe I missed another TAK-700 trial which he has i mind for you.

Joel

[Don1157 in reply to JoelT]

No, Joel, I have accepted the need for ADT, the cost of Lupron is the effect that I hate the most. I just mentioned that the rad oncologist said his treatment would only delay the ADT. Lupron may have effected my ECG results too, as I had a triple bypass seven months after I finished radiation treatment and while I was taking Lupron shots. Fortunately or unfortunately it was the ECG results that eventually led to the heart surgery. There was blockage. So I am concerned about the effects of ADT (and the study's other meds casodex and Tak-700) on my heart, cholesterol, blood sugar, etc.

[herb_8789 in reply to JoelT]

S1216

In the process of starting this trial at UCDavis ( Sacramento, CA )  Should know by April 8 if accepted.  I am 82, cleason 8, aggressive, PSA 13, ADT naive, one of the requirements.  Cancer has metastasized to hip and backbone.  I do not expect any life extending benefit but would have started ADT in the near future any way.  

I would recommend the book "Being Mortal" by Atual Gawande.  It has helped me in planing for my future care and end of life matters.

Herb     

[Don1157 in reply to herb_8789]

Herb, we are on the same wavelength, I "read" (audiobook) Being Mortal in late 2014, excellent book, before my bone mets was found. Now I am or shortly in the future facing the decisions found in the book. If accepted, I will start the trial the first of May. Thanks for reminding me Herb!

[JoelT]

Herb,

Hope you are accepted and thanks for participating in a trial. Trial participants are my hero.

Joel

[Don1157 in reply to JoelT]

I did not get into the TAK700 trial because of heart issues.

[katpow]

My husband just entered this trial last month and has his first follow up appointment this Wednesday. His worst side effect so far has been tiredness and one bout of constipation. I will follow up after his appointment if anybody is interested.

[Don1157 in reply to katpow]

Would be interested Katpow!

[katpow in reply to Don1157]

My husband has been in this trial now for 18 months. He has follow ups every three months where he has his blood drawn for PSA levels and receives his next Lupron shot. His PSA started out at 581 when the trial began and went down to 1.1 over the next 15 months. His last check up was in November and this time his PSA had a small rise, it was up to 3.1, I guess we'll what it is when he returns in January. I have seen major changes in him since beginning this trial. This is a man who goes to the gym everyday but it is now a struggle just to find the energy. It is hard to watch.

[wesmac]

I have been on the trial (Lupron+TAK 700). Started on the trial last June. I had previously had surgery plus radiation for prostate cancer 10 years ago. In May of last year it was determined that the cancer had spread to both pelvic bones and several lymph nodes. As I said, I began the trial in June and so far the cancer has remained in remission. The largest spot on my pelvis has shrunk to half the size it was a year ago. In the past when I was on Lupron only, the cancer went into remission so I don't know if it would be any different today if I was on just the Lupron. My only alternative would have been chemo so this treatment plan is much easier to handle.

[Hidden]

Been on Tak-700 for almost 2 yrs now..currently no visible signs of P. C. My PSA is negative..I also did radiation,but wasn't a candidate for surgery and thus avoided chemo..Also went holistic & no sugar, meat , or processed food.I am 55.also did all anti testosteroneshots like luprpne until orcheoectomy 9-1-17..Good luck! Be proactive!!