I am 67 and had a PSA of 8.9 and a grade group 4 Gleason score of 4+4=8. I had radical prostatectomy with lymph node dissection on 12/1/2022. I am on the road to recovery.
The pathology report showed 60-70 % of prostate involved by tumor with extraprostatic extension present, non focal. The lymph nodes negative for tumor, fibrovascular tissue over prostate negative for tumor. I have been told that the likelihood of needing additional treatment is high due to the aggressive cancer.
I have a ultra sensitive PSA blood test set for March 1st (3 months after surgery) to see if the PSA is below the target level of 0.2 ng/ml.
My surgeon has told me that I may be a candidate in a clinical trial (ea8183 eradicate) is what to search to find the trial. It is a phase 3 double blinded study of Early intervention after Radical Prostatectomy with Androgen Deprivation Therapy with or without Darolutamide vs. placebo in men at highest risk of Prostate cancer mestastasis by Geonomic stratification (ERADICATE)
I have an appointment with a medical oncologist on December 30th to find out more details. I was told by my surgeon that this trial will likely want to start treatment before I get the PSA test done on March 1st. which will muddle the actual reading by forcing the PSA number down. At this point I’m not sure to wait out the three months and find out if the surgery removed the cancer to a 0.2 level or jump into this trial not knowing if I will get the placebo or the trial drug??I am open to any thoughts, suggestions or ideas from anyone who has any experience on this matter.
Thank you all,
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MrDexter
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My case is very similar to yours, details in my profile. The numbers you are looking into are wrong, sorry. First PSA test 5 to 6 weeks post surgery. If results are good then the following test will be at 3 months. Target value is less than 0.02, not 0.2. If 0.06 or higher, dubbed as "persistent" ( a eufimism for failed surgery), than additional treatment is warranted.
thank you for your time and thoughtfulness. I’m not surprised if my understanding of timing what numbers should be. This is all so overwhelming. My next appointment is with hematologist / oncologist on 12/30/2022. Hopefully he will have answers to questions.
If you can think of any specific questions i should ask him please let me know
I can confirm the experience regarding timing for the first ultra-sensitive PSA test following RP: For me the first was 6 weeks after surgery, the result of which fortunately was <0.01 ng/ml, despite adverse pathology with some positive margins and a rating of T3a. Based on my experience, I suppose that the RO or urologist will prescribe that you have an ultra-sensitive PSA test done in mid-January.
I share your reservations, and have a few more reservations.
We know that salvage radiation may be curative in many men who have high-risk PCa that has been treated with prostatectomy. We also suspect that salvage ADT alone is not curative. I doubt that adding darolutamide will make it curative.
If you have persistent PSA, salvage radiation is a proven option. Perhaps (depending on insurance) that can be intensified with a second generation hormonal if your Decipher score is high.
Thank you for your reservations. I appreciate your time and thoughtfulness. I don’t think I have a Decipher score at this time or at least It hasn’t been mentioned to me or in any reports I have read.
If I would be you, I would follow Tall Allen‘s recommendations and go for salvage radiation if RP alone will fail. And I would also go for a PSA test after 5 weeks latest (I’ve had mine even earlier). Did you have a PSMA Pet scan already?
I was in a similar trial - with 6 month intensive ADT before surgery (whereas your trial would have intensive ADT for one year after surgery) but the idea is similar.
Here is the thinking behind the trial. Surgery for high risk prostate cancer is often not enough. Some micro cancer cells may have escaped. The standard approach like tall Allen notes is if there is recurrence you get radiation for the escaped cancer cells. Many studies have shown that regular ADT alone is not enough to kill the escaped cells, but radiation can do it. But there are now more potent drugs. What if we added this (in your study Darolutamide) to ADT? Would it be enough to kill any escaped cancer cells? Early results from similar trials show it seems to work for some people (maybe 20-30 percent).
So why do the trial rather than the standard of care of waiting for recurrence and then doing radiation? In my case, I was fairly young (61) and I thought radiation may cure the cancer but cause other issues in the long run. I was willing to take my lumps now (eg short course of intensive adt) in the hopes of avoiding long term effects of radiation (secondary cancer, cv issues, urinary/bowel issues). If it works great, the period of intensive adt is rough but you get over it. If it doesn’t work (eg there is recurrence despite the treatment) you can always do radiation then, so you have not excluded this option.
The biggest concern I would have with the trial is that it is a double blind trial where half get a placebo. So you really don’t know what your treatment is. If you like the idea of the trial but are concerned with the placebo idea, You might do a search to see if there are any trials on this that are not double blind (I think uc San Diego might have something like this).
FYI, I was Gleason 9 but it has been 2 and a half years since surgery/intensive afy and no recurrence. So in my case the intensive adt may have helped.
I had ‘only’ 4+3 but adverse pathology (worse than yours) . Chose a trial of ADT and abiraterone post op (2019). Also 4 rounds Taxotere chemo, followed by whole pelvic radiation and continued ADT for 18 months total. The chemo probably didn’t do anything but overall I’m glad I chose an aggressive approach so far. PSA undetectable throughout. Off ADT for over 27 months so far.
Make sure you get a PSA and testosterone before you start any trial. Great luck to you!
Stay healthy, research-new things coming up all the time. Just completed Trial Study LuPSMA177 at Dana Farber. I found out about this trial here. Contacted the Doctor directly. First one to complete the trial with zero help from my MO.
ADT can halt progression but is not curative, and the side effects are crummy for most men. Your health is more important than contributing to a study. Do what is best for your health.
PSA doubling time is more important than the absolute value. If it was me, I'd have PSA tested every month or two and have local radiation at the first sign of an increasing trajectory. The earlier it rises after RP, the bigger the battle and the more weapons are usually needed.
At this point why not do the test at 10 weeks? That's what my doctor recommended post-op. The test is cheap...do one before and another after. My profile will show you a very similar Dx. GL9, decipher high agressive results. My present PSA is undetectable. On no meds of any sort at 3+ year mark. What was pre-op PSA?
My situation was similar to yours in that my PSA was 8.6. MRI showed cancer in the prostate. PSMA PET-CT scan showed no mets. Biopsy showed high grade cancer with Gleason 9. Urologist put me straight on ADT (Zolodex) to shrink prostate away from bowel wall. Then I had high dose radiation Brachytherapy followed by EBRT. Been on ADT for 18mths now, two more implants remaining. Side effects are a bummer. Also have to take Doublets (Tamsolosin + Dutasteride) to enable me to pee. All this seems to be the right choice for me as directed by my Urologist and RO. Blood test every 3 months have shown my PSA is .008 and Testosterone 0.5< for the last 3 tests. Hopefully I am on the right track to achieve remission. BUT, only time will tell. Hope this provides some insight for you. Always stay positive, exercise if you can even though sometimes the motivation is not there, good luck on your journey, because that is what it is, a journey none wants to be on.
I would not be inclined towards that trial at this juncture due to the placebo arm possibility. Would prefer early salvage radiation due to the ECE and high grade of tumor. See if PSA is undetectable postop. If not, consider it Early BCR and go for SRT. Short term ADT included in optimal strategy with it.
Was the pelvic LN dissection extensive, or just a sampling? If the latter, discuss including pelvic fields in the SRT. Go for a cure!
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