Help With Treatment Decision

Hi DonJ. Sorry you're at this decision point in your PCa journey! When you speak of "doing nothing," if your PSA is doubling, your cancer is certainly doing something -- perhaps forming micromets. I don't think you can look at the possibility of clinically progression-free months in isolation -- you don't know how many months your lifespan could be shortened by waiting. In other words X months up-front could actually mean many more than X months overall.

As far as that trial, I would search (on pubmed or google scholar) for recent studies (including review papers) to see if either arm B or C has a meaningful advantage according to other studies (probably not), since you could get randomized to any arm. (I checked and the randomization is 1 : 1 : 1). Since it's an open-label trial, you could go through the scan and randomization and then withdraw if you get an arm you don't want and then do your preferred treatment with your docs. Anecdotal forum posts are fine for some info, but I would go by published study results when choosing, along with my docs' knowledge and experience. Some trials can have many advantages, including drug costs, study visits, scans, tests, etc. Check also for any travel/meal reimbursements Not all costs are always covered, however: things that are SOC are often not. If you intend to enroll in the trial, make sure you ask to take the Informed Consent Form home to read before signing. They are often very long documents and it's better to read it carefully. Then you are better equipped to ask questions when you go over it with the research nurse, when you will initial each page and sign the last.

Metastatic Prostate Cancer: Sorting Through the Treatment Maze (ASCO Post, 2020)

What I think or would do in your shoes really has no value for your decision making, but I would point out that you have been a good fighter up to now!

Keep us posted and good luck!
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Two suggestions if you aren't very familiar with searching the med literature: (1) start with 2020 articles and (2) rely on any recent Review articles you find. When reading a paper, you come across a claim or mention of another study that interests you, use the reference number given and the paper's Reference section to work your way back in time to other papers. Review articles are especially valuable: they do the research for you by finding all the relevant studies, select the meaningful studies pointing out caveats in some study results, and sometimes draw meaningful conclusions. I find that working backwards with the aid of Review articles is the best way to armchair travel

Djin

DonJ,

You're now in the "grey zone" where there isn't firm agreement on when to start palliative treatment, as highlighted by the differing opinions of your doctors.

Your Uro's suggestions mirror the views of the three MOs who have treated me. However, I agree that your six-month doubling time is concerning.

Your MO's sense of urgency seems like an overreaction to me, but I ain't no doctor.

The proposed trial makes no sense to me. The current standard of care is Lupron + one of the second line ADT medications: Zytiga or Xtandi or Erleada. If you do the trial you either have:

A) Lupron alone, which is known to be inferior.
B) Lupron + Erleada, which is a standard of care.
C) Lupron + Zytiga + Erleada. Do you really want to deal with the side-effects of three ADT medications?

In your boat, I would start an SOC palliative treatment when You are ready to do so, but that's just me

Good luck!

Thank you all for taking the time to respond. I realize that I needed a reality check. Gleason 9/10 cancer can get out of control quickly and if I let it do that to soon I may look back and wish I'd put up with the discomfort of ADT now. Thank you. Don

Hey Don, I am in AFT-19. I was randomized to ARM B - degarelix (aka Firmagon) + apalutamide (Erleada). I started treatment in February 2018, nearly 3 years after my prostatectomy and 1 year after 39 sessions of radiation to the prostate bed. I had eight months of undetectable PSA after the prostatectomy, but the radiation had done nothing to slow the progression of the cancer. When I began treatment, my PSA was only 1 but doubling time was, like yours, around 6 months. That didn't seem like time for alarm, but I did the arithmetic. A doubling every 6 months would mean 1,024 times as much cancer in 5 years. Yech. That was enough to persuade me that "I could NOT do nothing". Like you, I had had a recent highly sensitive scan (mine was a Ga 68 PSMA-MRI) that showed no visible mets that my radiation oncologist could blast. This meant that the cancer growing in my body could only be attacked with systemic treatment. At the time (and I should say I have not kept up enough to say that this is still true), the standard of care was ADT though not necessarily as early as a PSA of 1. Mattam says the current standard of care is "Lupron + one of the second line ADT medications: Zytiga or Xtandi or Erleada." I don't think that's the case for patients whose cancer is still castrate-sensitive, i.e., responds well to ADT. (Moreover, I don't think the standard of care specifies Lupron over Firmagon, which i believe has some meaningful advantages over Lupron.) I think Mattam is probably recalling results of trials involving metastatic castrate-resistant PCa.

When I decided to enter the trial, I heavily valued the ability to help fellow patients by becoming part of a clinical trial to see if either of the experimental arms would outperform the standard treatment. Little progress will take place unless we take our chances in clinical trials. It's an opportunity to take a lemon (PCa) and make lemonade (better treatments in the future).

At minimum I'd be hitting the micrometastases early and hard with degarelix. There was no way to know from previous research whether the second and third arms would do better overall (considering side effects as well as the effects on progression of PCa). Also, I considered apalutamide to be promising based on studies of those with castrate-resistant PCa. The only way to get a year of apalutamide without paying $120,000 (or some such astronomical amount) was through the trial. I was nervous about adding side effects to those of ADT, but I enlisted with a full commitment to do my one year of duty in the trial no matter which arm I wound up in.

You probably want to know how it went in Arm B for me, but, of course, the whole point of clinical trials is to get enough people going through the experiment to escape from anecdotal evidence and reach statistically meaningful results. My story is only my story, but here goes:

I had really bad hot flashes, as often as one per hour in the first few months, but these became significantly less frequent after a few months. I got a little handheld battery powered fan that I grabbed for whenever I burst out in a sweat. The hot flashes were generally all over in 3 minutes. They made me miserable. I had some other changes to my body that were disturbing but did not result in physical discomfort. I don't think I suffered any side effects that were specifically attributable to apalutamide. (By the way, the name Erleada was not unveiled until after I began the trial).

I got my last shot of Firmagon in January 2019 and took my last daily dose of apalutamide a month later. Since then, I've gone to the lab once a month to have my testosterone and PSA checked. The testosterone has climbed back to 90% of where it was before ADT. My PSA has been undetectable since I began the clinical trial nearly 3 years ago. Had I done nothing and simply waited for 3 years while my PSA kept doubling every 6 months, my PSA would be around 60 by now.

I agree with Djin's advice in the post above. If you want help sorting through the scientific reports, some of us do a lot of reading and have secret decoder rings for medical terminology. I am not very active on this forum, but I'll try to keep an eye out. I'm delighted that I don't have make any decisions right now, but I know what it's like to have to make the big decisions in fighting this disease. If you have any questions about the trial or my experiences, don't hesitate to ask.

PS, Technically, the FDA approval MAY state that the SOC I described is okayed for hormone sensitive men with demonstrable mets, but I know men who are on these treatments, including myself, without visible mets, and insurance still willing to pick up the tab.

Tomson, thank you for posting. It is so helpful to hear from someone that was in the trial. I hadn't done that math on the PSA doubling time but your example shows me how quickly my PCa could grow and worsen. Also, I too would like to help future fellow patients. The responses to my post have helped me decide to continue going forward with the trial, get the MRI and Body Bone Scan and then see which arm I'm randomized to. You are right, we humans can do almost anything for 12 months. I really appreciate you and the others for responding!

This is an apparently unpopular opinion, but I'll throw it out anyway. Low-dose estrogen via transdermal patches can relieve the symptoms of having no testosterone. Dr. Charles "Snuffy" Myers did this with his patients on long-term ADT, 0.025 to 0.05 mg/day patches, changed twice weekly.

Some have said estrogen will aggravate PCa, but it seems that could be evaluated by watching the PSA.

Just something to consider.

Duck2, I'm no expert on all of the latest science regarding estrogen and PCa. I'll just offer a couple of thoughts.

Estrogen has been used as an actual therapy for PCa. There's much about clotting issues from it, though much of that concern comes from quite old work that involved equine estrogen, not bioidentical that we have today.

This link: Prostate Cancer Treatment – Estrogen Therapy: Estrogen Patches offers quite a few links and some information about it.

My personal assessment based on reading a lot about this over the last few years is that estrogen supplementation is very low risk indeed, and it's too frickin' bad that so many men suffer so much from ADT when there is a pretty easy way to mitigate the side effects (loss of bone density, fatigue, and hot flashes). Full disclosure, I am on estradiol patches myself, now, and plan to continue.

But again, that is strictly my personal position, and it is in no way any kind of advice for anyone else.

Redwing, are you boobs growing?

NPLover, Thanks for posting. I'm right there with you knowing it's time to fight. We've both enjoyed "time-off" so to speak. Arm C does sound like overkill. I don't want to be so burdened by SE's that QOL is practically non-existent. Arm B would be the best to get into but no guarantees. I think Degarelix would be a good place for me to start. I did it in 2013 and it dropped my PSA from around 14 to 3.38 in 3 months (just prior to surgery). I also need to consider other factors like relocating from AZ to the NW to be closer to our children so my wife has more support. I don't think I want to hang around in 110 degree heat this summer feeling terrible. I'd rather sit by a stream or lake and feel terrible and see my kids and grandchild more. I am going to see if I could continue the trial in the NW after starting here at Mayo. If not I may just go for ADT. The Mayo oncologist mentioned that ADT could be intermittent. I hope the trial works well for you and you get ARM B.
Redwing57, thanks for the information on Estrogen patches. I hadn't heard about that other than my brother-in-law is on them along with Lupron for his recurrent PCa. He lives in the Seattle area and from what I've heard he has no additional symptoms other than mild ones from Lupron. Maybe the patches are helping.

Don,
Best of luck in your randomization lottery. As I said above I was hoping for arm B but was randomized into arm A. But as it has turned out the Degarelix-only treatment has worked very well for me. Your accelerating PSA trajectory is very similar to mine before I started treatment. My pre-trial scans - standard CT and bone scans showed one enlarge lymph node but nothing else. After the one-year course of Degarelix PSA was 0.00 and I as on break from ADT for nearly two years.

I just did a second round of ADT starting when my PSA had climbed to 5.5. Axumin PET scan just before I went back on ADT showed some enlarged left iliac lymph nodes and some enlarged nodes in area of prostate bed. Spot radiation was ruled out due to location of some of the nodes. I had a 3-month Elegard shot this time because, due to COVID, I didn't want monthly trips to the hospital for Degarelix shots. I just had a follow-up visit with my MO at Dana-Farber last week. PSA was down to 0.15 - below 0.2 so I could have opted to pause ADT, but doc and I agreed to a 1-month lupron shot. I'll check PSA in a month at my local hospital. With luck that will push PSA down further to undetectable. But either way I will be on break from treatment again for as long as it lasts this time. Will see MO again in September.

I can't complain with results so far.
Jim

Don, with a PSA of 4.5, it’s doubtful that scans will show any Mets, you are looking at it from the perspective of “big jump from 3.1”. It is. But it’s still a fairly low number