Beat Prostate Cancer

[Todd1963]

I was reading some clinical trial data the other day. To summarize, the treatment being tested did not pass muster. It worked marginally better than standard of care but not well enough to change standard of care. The irony of the study concerned overall survival and progression free survival. The control arm OS median was 70 months. That was the highest it had ever been. The study credited new hormonal therapy drugs for the difference in previous studies. Honestly, that’s pretty amazing and I am grateful for the research that has gone into these clinical trials that has brought us these new and amazing medication’s. It’s not enough. I am grateful for every clinical trial. I’m grateful for every new drug that comes of it. I’m grateful for the best and the brightest out there trying to cure this disease and trying to give warriors added time to their life, but we are still losing too many husbands, fathers, sons, and grandfathers.. We will beat this disease. We can do better.

[Tall_Allen]

I've noticed that too - the bar keeps getting higher, which is a good thing. What really slows down clinical trials is the very long natural history of the disease in most men, which is also a good thing,. But when overall survival is the endpoint, it takes over a decade to get usable results. Thankfully, the FDA has agreed to accept metastasis-free survival as a surrogate endpoint. But even that takes too long when the patient is starting with localized PCa or a first biochemical occurrence. I've tried to convince doctors to accept biochemical recurrence-free survival as an endpoint (which occurs about 5-8 years earlier), but I've so far been unsuccessful.

The accelerating mutation rate makes it harder to find solutions as time goes on. As you, of all people, can attest, early, treatment seems to be critical. Many combination therapies (like triplet) are proving themselves. Real world results aren't nearly as good as clinical trial results. Convincing patients to accept such strong therapies when they feel OK now gets a lot of pushback. What can we do on the patient side?

[TC007 in reply to Tall_Allen]

US has lot of past baggage which makes things slow as hell. I know that lot of research is moving to countries in Asia like India as the turnaround time is quite fast and the controlled group is also quite diverse.

[Tall_Allen in reply to TC007]

Some countries (notably Germany) have a "compassionate use" law that allows patients to be treated with experimental therapies. The US has such a law, but the pharmaceutical company has to agree to provide it, and it will usually be prohibitively expensive. In the US, clinical trials are the only way to get experimental drugs without cost. Most countries (even those with compassionate use laws) rely on the US FDA for approval of new drugs. Some countries don't approve even those drugs based on cost/benefit analysis.

[NJWarrior in reply to Tall_Allen]

I participated in a clinical trial once I was diagnosed. I was terrified with the diagnosis and decided the best option for me was to be a guinea pig. The trial was for G8+ on biopsy, no spread. Three arms-SoC, Apalutimide+Lupron and Apilutimide+Lupron+Abiraterone/Prednisone. I was in the third arm. The medication took a toll on me with memory loss, trouble speaking clearly, heavy fatigue and other less annoying side effects of ADT. Surgery was performed 3 months after the drug therapy. At the time of surgery my PSA was undetectable and the prostate shrunk to about 60% of the size before the therapy.

Overall, I rated the trial a success for me. I'm still waiting for the doctor to provide me more of the clinical results from the study but he indicated that preliminary result look promising.

I know participating in a CT is going to get the patient exceptional care before and after. I've heard of others being released to the care of the PCP 3 months after surgery. My study duration is 24 months post-surgery with quarterly check ups.

[maley2711 in reply to Tall_Allen]

do the best to provide the data about the effectiveness of the treatment compared to a lesser treatment, do the best to honestly inform the patient of probabilities of any side effects, and ask ...in the worst case and you do encounter the worst case scenario with side effects, which you probably fear, would you prefer to deal with those SEs for x months now, with x months of OS survival advantage, or , based in experience with the lesser treatment, have better QOL now for x months, but earlier occurence of the horrors of late metastatic PCa. Do not overpromise..be honest........ and openly discuss the horrors of end-of-life PCA disease. I'm just assuming the horrors I've read about are the norm?

IMHO, men fear that advanced treatments will destroy what few good years/months they have left, and then they still face the horrors as it rages out-of-control eventually anyway. But maybe I'm nuts?

[Apisdorsata in reply to maley2711]

No, I don't think you are nuts. You've expressed my feelings very well. It's a very personal decision that each person has to make for themselves. As Tall Allen pointed out recently treatments for castrate resistant disease, on average, do not offer more than a few months of extra life. These treatments have real side effects. But the hook is that sometimes the more toxic treatments give very durable responses. The problem is am I one of those people who get the really good response or will I just get sick for a small overall life gain? So far I haven't had to make that decision but I know it is likely that I will someday.

[maley2711 in reply to Apisdorsata]

Thanks...yes!!!!!!!!!!!!!!!!!!!!

[Todd1963]

I don’t know Alan I wish I had the answers. There really isn’t a lot of us guys out there. I suppose in a perfect world we would all sign up for a clinical trial if qualified in the name of science but it is kind of hard to roll the dice with your life.

[tango65]

The long term results of the Stampede trial using abiraterone and ADT showed a median OS of 6.6 years (78 months).

urotoday.com/conference-hig...

The median overall survival for low volume disease may be longer.

These results may be similar or better than triple therapies for castration sensitive cancer which compared OS with ADT plus docetaxel.

[Adlon57]

It makes me feel so small when I see "Everybody is different" in other words there is a chance you won't recover. How PC is so in the dark, how much is really needed for that "all clear" so many options, how many strings HAVE to be pulled to get more 'cures' realistically feasible? It goes on as it increases its black clouds, more research has to widen its fields, so many mutations, as Tall_Allen says foreign countries will have to amalgamate their findings! "What can we do on the patient side?"