Have you been offered a Clinical Trial? If so I need your input.

Looking for cancer survivors that have been offered a clinical trial. I need your thoughts on the experience of deciding to or not to be a part of it. Doesn't matter the site of origin of the cancer. When I went through the initial phases of being diagnosed with an advanced cancer, I was offered and ultimately declined a clinical trial after surgery showed that they didn't get all the cancer. My reasoning was that the trial did not allow me to take on follow up radiation. I would have been randomized to either to watch and wait until progression versus hormonal therapy or chemotherapy or both. I decided to take on HT and radiation and forego chemo. It worked. But the experience of being asked to join a clinical trial was surreal. I was shaking in my shoes. I will be authoring an article for a major publication with my buddy Rick Bangs on the patient experience being in or declining a clinical trial. If you've been there, your input is valuable to me. Both Rick and I are very excited to have been approached by an MD Anderson surgeon/professor to do this article. But we both want to do it right. Our target audience are oncologists.

Being randomized would not appeal to me given the shoes I'm in. What's the benefit unless you're terminal?
Bob

Break60,
That's a common misunderstanding of the clinical trials. There are a lot of clinical trials that well suited to non-terminal patients at all stages. There is always a need to improve the standard of care but the only way that will happen is with trials designed well and safe for patients. There are many types of trials available today such as the MEAL trial where half are randomized and given nutritional coaching vs. no such coaching at all that is intended to prove that a healthy lifestyle after a diagnosis helps both the patients quality of life and possible helps fight recurrence of the disease.

There are many trials that are trying to improve outcomes for the stage 3 guys and earlier. I was offered a trial as I mentioned above but stayed out because I wanted radiation add to my options. That trial had a hard time accruing and was stopped and redesigned to allow it after I was no longer eligible. I would have joined it easily had that been an option. This was ten years ago and today we know through trials that the way I did end up going had a much better success rate than believed in 2007. And thanks for those trials that proved it because mortality was in fact reduced in those trial. Those patients would not be considered by any means terminal at that point in their trek.

There are also many active surveillance versus intervention trials out there in patients with moderate/intermediate disease. These are great and needed trials that can help us define who may or may not be best candidates for as or interventional therapies.

Lastly, Many trials are made safe by using the standard of care in the control arms. And many times the active arm is the standard of care with and added agent so either way you would get treated. This is true in many immunotherapy trials going on today, i.e. Prostvac, and PD-1 and PD-L1 trials for men with intermediate to high risk disease. Which may great trial options for someone like yourself though that would be determined by your oncologist.

Post Edited (Tony Crispino) : 3/20/2017 12:01:23 AM (GMT-6)

Two experiences. First, for non-CR hormone naïve, arms of Firmagon, Zytiga, or both. I was expecting to start Firmagon, so I said yes, but my PSA was rising too slowly to qualify. More recently, I went to Houston to pre-qualify for a trial offering Apalutamide on both arms, both with Lupron, but one arm delaying the Apalutamide for six months. That was in September, the trial opening was then postponed a couple of times, and finally, in December, after another postponement, I gave up and started normal Firmagon. The second trial appealed to me because it seemed to offer a far better chance of a durable remission than is usually achieved with normal ADT. It still has not opened.
First trial:
[url]https://www.clinicaltrials.gov/ct2/show/NCT01751451?term=abiraterone&recr=Active%2C+not+recruiting&rslt=Without&type=Intr&rank=15[url]
Second trial:
[url]https://clinicaltrials.gov/ct2/show/NCT02811809?term=ARN-509&rank=17[url]

Prior to my surgery I was offered a chance to take part in a trial and declined.

In my case, however, it was not a trial for a new treatment for the cancer, but a trial for a new idea for helping to reduce incontinence. Not sure what the exact name for the type of trial was but I think it’s a double blind in that neither the patients nor the staff treating them after surgery would know if they were or were not part of the trial. I thus declined on the basis that I wanted to know that I was the one that was in control of my bladder.

The new technique involved the surgeon fitting a sling at the same time that he removed the prostate. And not just any old sling, but one constructed out of a length of the Vas Deferens that was going to be nipped out while doing the surgery.

Another aspect that contributed to me saying "No" was that this would make the operation longer and I did not fancy that.

Alf

After my DX my URO at UAB asked if I would like to participate in a blind study to see if a genetic marker of some kind could be detected in the blood of men with PCA that would eliminate more invasive testing. It required nothing of me except letting them use my blood for more research, I accepted. After I decided on SBRT my RO at UAB also, asked if I would like to participate in a study to test the toxicity of standard SBRT with an intergrated boost to the specific tumor. The treatment was 5 fractions @6.25gy with an intergrated boost of 8gy. It requires that I go back to UAB quarterly for the first year and fill out an EPIC survey and then bi-annually for the next year. I accepted that also. Tony I don't know what else you might want but I will be glad to help anyway I can.
Perry

I was offered to join the TAK-700 trial 2 yrs ago when I was first DX'd. My MO is at a leading research university, where I worked as well before retiring. I was excited to be able to join, as research has just been something that is part of my life; sort of second nature. I was also pleased that it seemed that I was getting a degree of special attention that I would not have gotten otherwise, with extra people monitoring me, getting tests scheduled and paid potentially paid for, etc. It was a very low-risk trial, as they were comparing this drug to bicalutamide (Casodex), so it was not really much of a primary treatment change. I ended up in the control group, so it was actually no change from the standard of care. When I failed HT after 18 months, my participation was done. I would absolutely be interested in doing another.

Devasted1 one we're over due for a call.