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Apalutamide or Prostvac or Firmagon?

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Posted 12/6/2016 2:06 PM (GMT 0)
My plan was to go with a trial of Apalutamide (NCT02811809) but the opening of that trial has been delayed again and again and my PSA is rising and there is increasing evidence of the benefits to starting ADT sooner rather than later. Should I hold out for Apalutamide (which I think has some prospect of a durable remission) or switch to a trial for Prostvac (NCT02649439) which I am convinced is quite effective, but, as far as I know, offers little prospect of a durable remission and some in the trial receive no treatment of any kind for six months, or punt and go with normal Firmagon ADT? Quite subjective question, but my thinking could use some help. See signature, but, briefly, RP, then SRT, and later IMRT to para-aorta and common iliac lymph nodes accompanied by four months of Firmagon, followed by a rapidly rising PSA after the Firmagon wore off.
Posted 12/6/2016 2:26 PM (GMT 0)
There are a few papers over the last three years that suggest benefit from PROSTVAC treatment is most pronounced in people who are NOT of blood type A or AB-

the latest paper is here:

/www.ncbi.nlm.nih.gov/pmc/articles/PMC4741674/

rf
Posted 12/6/2016 2:36 PM (GMT 0)
Cigafred,

I believe your doubling time has to be greater than 5 months in order to be eligible for Prostvac. We checked into it for Randy, but he didn't qualify because of a PSADT of 6 weeks.
Posted 12/6/2016 5:34 PM (GMT 0)
/prostatecancerinfolink.net/2015/11/03/whatever-happened-to-arn-509/
Posted 12/6/2016 6:59 PM (GMT 0)
RandyJoe
Thank you, yes, your are correct, but due to a pause for a couple of months in my PSA growth, and the specific way they measure, I believe at the moment I qualify even though for most of the time, before and after the pause, the doubling time was about 3 months.
Posted 12/6/2016 7:02 PM (GMT 0)
Fairwind, thank you, I am not CR so do not qualify for those trials, my target trial is for the non-CR.
Posted 12/6/2016 10:52 PM (GMT 0)
Perhaps you're getting hung up on terminology. By "durable remission," I suppose you mean a PSA decrease. Remember that's just one indicator of progression. The promise of immunotherapy is an increase in survival, which is really what you want, isn't it?

Another interesting "strategy" I'll put out there, is a newly announced trial of the DCFPyL PET (NCT02981368 - Cohort B) in multiple locations. It is the most accurate PET now available. If it is able to detect a bone met, which could qualify you for the big apalutamide trial (NCT02489318) that is already recruiting. They say they want a bone scan/CT but they might accept it. Just a thought.
Posted 12/7/2016 12:02 AM (GMT 0)
Thank you, Tall One.
I really did mean "durable remission." Dr. Amato, running the apalutamide trial at Memorial Hermann, said he expects something like a 33% share of participants to have a durable remission. While I in no way take that as being bankable, it is encouraging and is what has kept me waiting for the trial to open. Prostvac (I am convinced) and Firmagon certainly prolong survival, but I have not seen any reports that either have much likelihood of a durable remission.
Posted 12/7/2016 6:12 PM (GMT 0)
But what does Dr. Amato mean by the phrase "durable remission?" Undetectable PSA? Shrinking of detectable metastases? Longer survival? Cure?
Posted 12/7/2016 10:02 PM (GMT 0)
I understand it is a PSA value below 1.0 ng/ml.

At clinicaltrials I read: "Participants remain on study until continuous ADT is required to maintain castrate PSA levels (i.e., leuprolide is needed every 3 months to maintain PSA <1 ng/dL)."

So the participants at the end of the study period who still have a PSA value below 1.0 ng/ml could be considered to be in a durable remission. How long that will last after the study period nobody can tell.

George
Posted 12/8/2016 2:04 PM (GMT 0)
I do not know how others define "durable remission," and George's reading of the trial document seems reasonable to me, but I would define durable remission roughly as the ongoing, non-worsening of both PSA and of observable disease without incremental treatment, and so naturally I assumed that definition would apply when others spoke of "durable remission." The Wikipedia definition of remission is "a temporary end to the medical signs and symptoms of an incurable disease." Add to that "durable" and I think there is rough agreement with the forgoing. How long "durable" is I do not know, but personally I would think at least a year, and during that time no reason to believe that the situation cannot thus continue. I would be happy to accept any approximation of this as an outcome.
Posted 12/8/2016 3:26 PM (GMT 0)
Cigafred,
Personally, I like the term "durable remission". Dr Snuffy Myers uses it a lot in his videos.
Also as Allen reminds us, especially those of us with advanced "incurable" disease, our hope lies in longer term survival. However one defines it, "remission" shouts out to us of good news and a good status. Doctors in general do not like to even use the word remission, at all. I feel you cant attain it if you don't claim it! So I definitely do name it and claim it claim it!
And in some people like our friend Todd1963, I'm sure he would not mind me calling his status durable or even enduring or better still "everlasting remission!!!"
Keep the Faith, and stay strong my friend.
Wings aka Dan in Rainy So Cal
Posted 12/8/2016 6:21 PM (GMT 0)
Cigafred,

The point I was trying to make to you is that you seem to be hanging your decision on a term that has no real meaning. You and Dr Amato are free to make up any meanings you like, but the therapy does not have any such data attached to it. It's very nice if it causes your PSA to go down, but that in itself is really not a benefit. The bottom line is: will it increase survival or won't it? Immunotherapy, for example, has been documented to increase survival without lowering PSA. Other therapies, like SBRT to single metastases, may lower PSA and may control local mets, but has never been shown to increase survival.
Posted 12/10/2016 2:01 PM (GMT 0)
In the study details it says: "The purpose of this study is to determine the ability of Apalutamide to extend the time between the first two injections of leuprolide and improve quality of life."

Apparently Apalutamide is expected to extend the first "holiday" of an intermittent ADT with leuprolide. This does not mean that a durable remission is expected. That would be a very long holiday. Maybe Dr. Amato hopes for that.

Maybe you can already start with leuprolide now and be "randomized" later into group B of the study. Corriger la fortune :-)

George

P.S.
This is a new report about an Apalutamide study that has been finished: Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509)

Post Edited (George_) : 12/10/2016 7:57:12 AM (GMT-7)

Posted 12/11/2016 12:45 PM (GMT 0)
George,
Thanks, yes, you are correct about the posting for the study, my comments about durable remission are based on conversation with Dr. Amato. Also, I would have thought that being directly "randomized" into Group B would violate all principles of randomization, but I have nothing to lose by asking.
Posted 12/13/2016 5:40 PM (GMT 0)
Thanks Tall Allen.
For the DCFPyL PET, the only information on ClinicalTrials.gov is
"Study has passed its completion date and status has not been verified in more than two years." There are various other trials for this PET, but so far I have seen nothing that works for me. Same message for the apalutamide trial, but I will review the other apalutamide trials.
Posted 12/13/2016 7:58 PM (GMT 0)
The expanded trial for DCFpyL PET is:
/clinicaltrials.gov/ct2/show/NCT02981368

They've started it at Yale already, and other sites will be starting up soon. They have several ongoing ones at Johns Hopkins as well.

For apalutamide trials, put "apalutamide OR ARN-509" in the search bar. The big one is:

/clinicaltrials.gov/ct2/show/study/NCT02489318

The list of open Prostvac trials is:

/clinicaltrials.gov/ct2/results?term=Prostvac&recr=open
Posted 12/14/2016 1:03 AM (GMT 0)
Tall one,
So glad that you are back here after your respite, Many thanks and kudos once again for the trial info, definitely worth looking into.

Definitely don't want to squabble on semantics and interpretations, just want to agree that for most, increased survival(and QOL) is a definite benefit, and further that for others, terms that as you suggest say have "no real meaning" because there is no evidence, actually do show evidence(within) and do mean a lot!.
even if it might be psychological.
Wings
Posted 12/14/2016 3:57 AM (GMT 0)
WOE,

I'm not quibbling and it's not semantics. I think I'm asking you an important question because Cigafred's longevity and QOL depends on it. Both therapies hold the promise of increased survival, else they wouldn't even be doing clinical trials. He said that one therapy offers "lasting remission" while the other therapy doesn't, and that his decision seems to depend on this distinction. I don't understand how he arrived at that determination, and it's not necessary that I do - it's personal to him, obviously. I'm suggesting that he may be able to decide for himself based on what that term means to him. It's a subjective decision - there is no objective data to base it on. I don't think there's anything I or any other forum member can say that will help him - but self-examination can.

Whatever he decides, I hope it works!
Posted 12/14/2016 1:36 PM (GMT 0)
Thanks again Tall Allen, your contributions are invaluable.
Yes, it is subjective, but I think this discussion has helped my thinking. As for "lasting remission," I see it this way: There are lots of treatments for advanced prostate cancer, but seemingly all or almost all of them offer only an expected or mean increased survival measured in months. All or most of them occasionally result in a lasting remission, but that is unusual. Per Dr. Amato's molecular diagrams (no way I can recreate or explain those), he thinks he can demonstrate that in maybe 33% of all cases apalutamide can, with a leuprolide, stop the mechanism by which cancer cells learn to overcome ADT [no chemistry since high school, so I may have totally misunderstood]. If it works, a lasting remission, measured in years not months, would result for those cases. And in this trial everyone gets apalutamide. That is not the case for the other apalutamide trials for which I qualify. As for the 18F trial, my quick read is that Cohort A requires a prostate, Cohort B requires "Radiologic evidence of local recurrence or new or progressive metastatic disease . . ." so I cannot use it to find new metastatses.
Posted 12/14/2016 6:09 PM (GMT 0)
Cigafred,

Did they have an estimate of when the study would start up? It's a crossover design, so everyone gets the apalutamide. I can understand why you'd be anxious to get the hormone therapy started sooner rather than later. Would Dr Amato let you into the study if you started on Casodex? I see that the T level must be greater than 150 ng/dL, but Casodex should not affect that.
Posted 12/15/2016 2:34 PM (GMT 0)
Thanks Tall Allen,
I love the Casodex idea, I will ask them today.
When I went to see them in September they expected (and had so posted at clinicaltrials.gov) a September start. While I was there they said, with big smiles, that final documents had been signed that day. Then it was postponed, then postponed a second time to "December." It has not been easy to get any good feedback on where things stand, either they have some unpredictable factors or they don't want to commit themselves or some combination of both. It has been awhile since I pestered them, I will start another round now. The Casodex idea gives the perfect lead-in.
Posted 12/16/2016 12:16 PM (GMT 0)
I have asked the above questions, no response yet. But I would think that Casodex would probably sufficiently affect my PSA that I would no longer have a doubling time under 12 months as required by the trial?
Posted 12/16/2016 6:58 PM (GMT 0)
But will they accept your current pre-Casodex doubling time? They may be able to do that.
Posted 12/16/2016 8:21 PM (GMT 0)
I just got word, in response to my query as above, that there is another delay and no set date to begin (and they will accept Casodex, don't know about doubling time possibility). So I will punt and start Firmagon soonest. Thanks to all, and especially the Tall One.
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