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Posted 8/27/2012 10:56 PM (GMT 0)
I'm just curious which of our members considered a clinical trial and if they in fact moved forward with it. I was offered one when I set out after surgery revealed that I had bilateral seminal vesicle invasion. The trial I was offered was from Sanofi Aventis and it was a four armed trial that did not appeal to me since it did not allow adjuvant radiation therapy which I elected to do instead.

This is for my own education and having a pool of friends like we have here at HW I think it will be a great learning point for me as I have now joined SWOG as a patient advocate. I've started receiving upcoming clinical trial papers and it made me think to ask the HW pool their thoughts about trials. I am receiving some great training already and my role at SWOG is somewhat intimidating to me as it is clearly an active role with great responsibility.

So if you don't mind...

Did you consider a clinical trial?
Did you move forward with it?
How well did you understand the trial?
Are you still in the trial period?
Have you seen the results of that trial?

If you elected to not enter the trial, why?

Thanks everyone...peace...

Tony
Posted 8/28/2012 2:17 AM (GMT 0)
Tony, my PSA started rising last fall while on ADT 3 , during my last on cycle the nadir only dropped to 0.12.. then it started moving up gradually .Several years earlier after I failed both surgery and radiation, I transitioned my care to UCSF, based on their excellent reputation in treating prostate cancer. I knew that one day I would need their expertise .

They are also involved in numerous clinical trials. Anyway as my PSA was gradually rising and before deciding what to do next, I got a call from my oncologist.....he was suggesting a Phase II Trial with ARN-509 might be a good fit...the only problem was my PSA was still very low (0.52) and he wasn't sure I would be accepted.....I was .....and my research indicated this drug to be very similiar to MDV 3100...also there was no placebo.....before finally  committing I contacted Dr. Lam in LA ( I consult with him as well). Anyway I started the drug in April....my last PSA  earlier this month was .17, so I am responding.The only side effect is intense nausea for about 20 minutes after taking the drug. I feel lucky to have this opportunity...... BUT every 30 days a whole batch of blood work, followed 2 days later with more blood work...a meeting with my doctor, then a meeting with the trial coordinator to pick up my next month supply of drugs...every 84 days another lupron shot, every 120 days a CT scan and a bone scan...throw in an EKG and MRI and who knows what else they may need.Some times I feel that I might as well take up residence at the clinic.  Again I am lucky...I hope it continues to work.

Hope this helps.

Terry

Posted 8/28/2012 8:56 AM (GMT 0)
Husband would certainly consider a clinical trial. M.D. Anderson is looking.

The problem seems to be that he doesn't have confirmed bone mets and is not yet castrate resistant (both of which seem to be good problems), even though he has positive nodes, SVI, and bladder invasion.
Posted 8/28/2012 10:16 AM (GMT 0)
Tony,

Did a clinical trial of high dose Samarium 153 early on before my presentation of bone mets. I had little response. I continue to search for trials that match my inclusion criteria but the vast majority require HRPC status. Most even demand failed chemo. Indeed, by the time you meet the enlistment requirements for the most promising emerging treatments you need to be knockin' on heaven's door. I think that the clinical trial concept is skewed to reap the highest front end financial return. Then again why would we expect differently.

Jim
Posted 8/28/2012 4:05 PM (GMT 0)
Jim,
The drug business is a business and I'm certain there's money in the equation. But the primary reason for advanced drugs to be tested later is to minimize risks and rewards. Patients with failed chemo are more apt to partake in trials as well. So it is that drugs like Provenge, Zytiga, TAK700, MDV3100 are all in post chemo testbeds, but their best use may be elsewhere and such trials are underway or getting underway. Provenge and Zytiga (abiraterone) were tested at the tail end of treatment and were fast tracked because they were proven effective in many patients. Both of these drugs are commonly prescribed before chemo these days. And looking at a trial that I have received for review it's likely that the others I mention are better suited early on and the trial I am holding is attempting to prove just that.

But stay tuned, there are still options ahead for you. If you'd like help with it let me know I do have some incite but even better I have people in the know as well...

Tony
Posted 8/29/2012 8:46 PM (GMT 0)
Tony... you are my new best friend. Oh wait...you were already my best friend.
Posted 8/29/2012 10:11 PM (GMT 0)
TC-LasVegas, it is slightly incorrect ( about PROVENGE). Yes, PROVENGE was tested in very sick men , but some of them had chemo , some didn't have. FDA approved PROVENGE for men with asymptomatic or symptomatic castrate resistant prostate cancer regardless they have chemo or didn't have. The NCCN recommends PROVENGE as a first-line treatment and give Category 1A, the highest (NCCN Cat. 1 rating, the highest for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer ). A category 1 recommendation means that, “The recommendation is based on high level evidence (e.g., randomized controlled trials) and there is uniform NCCN consensus” about the recommendation".

ZYtiga was approved for use AFTER CHEMO by FDA. The NCCN give Category 2B .

https://www.healthnet.com/static/general/unprotected/html/national/pa_guidelines/zytiga_natl.html

It's interesting that the cited document contains the following statement: "Per NCCN guidelines, use of Zytiga as secondary hormone therapy for treatment of patients with no or minimal symptoms who are not candidates for docetaxel-based regimens is a category 2B recommendation.
Zytiga has not demonstrated a prolongation in overall survival in the pre-chemotherapy setting."
The pivotal Phase 3 trial of Zytiga in a pre-chemo setting recently was terminated when the trial achieve stat significant in ONE of two endpoints, progression free survival, or PFS. The trial, however, did NOT achieve stat significant for the other endpoint, overall survival, or OS.

But we know many doctors prescribe ZYTIGA in pre chemo (it is very easy for them because it is a pill . It is amuse me that with all that research papers doctors continue prescribe ZYTIGA before PROVENGE. It looks like doctors who treat prostate cancer today don't read the literature. The same doctors who treat prostate cancer don't treat blader cancer follow the NCCN,AUA, guidelines . Noncompliance would have had patient survival consequences.
http://www.curetoday.com/index.cfm/fuseaction/news.showNewsArticle/id/5/news_id/3209

Dendreon now is running a 60-patient, Phase 2 trial to examine the co-administration and sequencing of Provenge and Zytiga (the Journal of Clinical Oncology recommends Provenge be administered first).

http://jco.ascopubs.org/content/29/27/3595.full?sid=a9e276db-0ac1-4ca1-8fd4-a16a19e7151f%23sec-14

Dendreon also run the open-label, phase II NeoACT study explored the delivery of sipuleucel-T in the neoadjuvant setting in patients with localized prostate cancer. In the trial, patients received sipuleucel-T prior to a radical prostatectomy.
The study, known as PROTECT (PROVENGE Treatment and Early Cancer Treatment) or P-11, is a double-blind, placebo-controlled Phase 3 trial designed to evaluate Provenge in men with non-metastatic androgen-dependent prostate cancer.

http://www.onclive.com/publications/obtn/2012/July-2012/Sipuleucel-T-Studies-Support-Earlier-Use-Reveal-Potential-Biomarker

Post Edited (HOPENEVERDIE) : 8/29/2012 4:39:27 PM (GMT-6)

Posted 8/30/2012 12:31 AM (GMT 0)
HopenEVERDIE, you are quite the Provenge advocate. You seem to have a great deal of information regarding it's use. I am a Provenge patient so full well understand your feelings about the drug but it does seem like you might have a shade more interest in the drug than as a potential Provenge patient. This site is a patient to patient support group and even as strongly as I feel in regards to Provenge it is my hope that you do not have ulterior motives. Just an observation.If I am mistaken then my humble apology's. Kindest regards, Todd
Posted 8/30/2012 12:32 AM (GMT 0)
Not a moderator
Posted 8/30/2012 12:36 AM (GMT 0)

I was diagnosed with PC with a PSA of 200 which rose over a week to 250, in July 2010. I had CT and bone scans and a Biopsy all confirmed I had metastized PC to my bones and lymph nodes. My gleason was 50% 4+5, 40% 4+4, 1 negative from 12 samples. I started Cosudex for 30 days and then after 15 days Zoladex . My PSA slowly came down to 3.2 by April 2011, then my PSA see sawed up and down and by the start of December 2011 my PSA was 5.3. The ADT for me really only worked for about 9 months.

I had been doing some research on clinical trials and was very impressed with the results of the Affirm MDV3100 trial which was terminated early. I decided to see if I qualified for the Prevail MDV3100 trial which is for chemotherapy niave patients.

My reasoning was I would prefer to go early and hope to prolong my life while I still had good QOL. It was a gamble because of the placebo and that was always a worry to me that I would be one of the unlucky ones who scored the dummy ! I went for the examination and tests etc and found that I qualified and would be accepted if I wanted to proceed. There was a limited number of places available to me. I thought carefully and made the decision that I would proceed. I started the trial just before Christmas.

There is a fair commitment, which is fine by me. You need to keep a diary of your daily feelings (headaches, pains etc), monthly visits to the Doctor, in the begining bimonthly CT and Bone scans, monthly blood work, ECG, questionaire to fill in, there is really nothing too difficult, just the time. But if it works who can put a price on time.

My PSA still continued to see saw up and down, by May 2012 was up to 6.6, the April scans showed no change from December. This was good on one hand because the cancer didn't appear to have advanced, but with the PSA results I was thinking "murphy's law" I have the Placebo.

Mentally this was hard even though I knew there was a 33% chance of getting the placebo you just somehow want to believe that you will be in the other section. Then my PSA stablised and started to reduce, at the beginning of August (3 months later) it was 22% down on the May figure. Whilst this is still a long way from a lot of the reductions shown in the Affirm trial, it was going in the right direction. More importantly my June scans showed a reduction of the cancer in my bones and was now classified as unmeasureable ! There was still evidence of the cancer but. So maybe I am on the real  thing after all !

These results I think are a miracle, and I feel wonderfull news for fellow PC sufferers.

I had new scans yesterday and tomorrow I go to the Doctor to get the results and have another round of blood work. I am now impatiently waiting on tomorrow's results to see if things are still going in the right direction.

It is very difficult, you seem to live by the montly PSA number and the scan results. Your mood and outlook all hinge on this number, in my case I am very fortunate that , so far i don't have any pain in my bones. So the only real measure of PC I have are the PSA numbers, scans and my urinary problems.

about clinical trials I can only say that you need to think carefully, is the trial for you ? What will the drug potentially do for me ? Think why are you wanting to do it ? Talk to the Doctors and ask questions, what are the ups and downs of the drug ? But at the end of the day it may be your only chance to extend your life and at the same time have a good or reasonable QOL. I certainly don't want to end up lying in bed in agony for a long time oblivious to all.

Live life for today and enjoy.

I have posted elsewhere information on my experiences on MDV3100 in Healing Well.

Posted 8/30/2012 12:49 AM (GMT 0)
My brother was diagnose with prostate cancer 5 years ago. He had radiation and now he is undetectable. I am scared for him . HE is 49 years old. I know one day his cancer will return . He lives in other country . I try educate myself how much I can. It is took 5 years for me understand about prostate cancer a lot. I just in shock that maybe best of the best treatment ( my opinion) didn't receive proper recognition among doctors.
Posted 8/30/2012 1:54 AM (GMT 0)
Tony,

What does SWOG stand for ?

I am new here.

Thanks
Posted 8/30/2012 2:26 AM (GMT 0)
your brother is lucky to have you as an advocate. Thank you for the clarification
Posted 8/30/2012 5:44 AM (GMT 0)
HopenEVEDIE,
Thank you for the correction. Provenge should not have been included in my example, though the others should have. I also reviewed the Provenge/Zytiga trial this evening and it is currently recruiting.

Tony
Posted 8/30/2012 5:51 AM (GMT 0)
RangerTug,
SWOG used to stand for SouthWest Oncology Group. But they commonly went by the moniker SWOG. Eventually they changed the name to just SWOG because they felt that it was misleading since the had grown to a national and then international consortium of research oncologists. SWOG currently conducts about 80%+ of all prostate cancer clinical trials as well as many other major cancer trials. You can learn more about them here...
www.swog.org

Thank you all for your responses.

Tony

Post Edited (TC-LasVegas) : 8/29/2012 11:54:11 PM (GMT-6)

Posted 8/31/2012 3:04 AM (GMT 0)
 

Tony

I was in the Punch clinical trial at COH. After dx they asked me if I wanted to be in the clinical trial and I accepted. My dx was a gleason of 4+5 and a PSA of 5.4. All Ct and bone scan were negative. The trial was to have Texatere along with Lupron and than an RP. It started with Lupron with 6 sessions of texatere. Biopsy showed 86% of prostate with cancer. The trial was to see if by debulking the tumor before RP recurrance would be less likely to happen. PSA right before RP was down to .1. Path report after RP showed no lymphnode involvement but did have Sv invasion along with positive margins. It also showed that the tumor had shrunk to 28% in the prostate. My PSA after RP was <.1 and stayed their for 7 months. It than rose to .5 at which time I had radiation. PSA got down to .23 but started to rise again. I left the trial after this and am now seeing Dr. Lam. He put me on triple blockade for the past year and my PSA is now .005. I have just started triple blockade vacation. Although the trial failed for me I am convinced that it helped me get to my current PSA. I am now 41 month since dx. 

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