In a retrospective study, men with a prostate-specific antigen doubling time (PSADT) of less than 10 months saw a median metastases-free survival (MFS) of 192 months when they delayed ADT until metastasis, and a median overall survival (OS) of 204 months, reported Catherine Handy Marshall, MD, of Johns Hopkins University School of Medicine in Baltimore, and colleagues.
Marshall and colleagues found that the median MFS of men with BCR and a PSADT of less than 6 months was 144 months, with a median OS 0f 168 months.
They noted that the SPARTAN trial, a phase III study of apalutamide (Erleada) versus placebo in patients with nmCRPC, demonstrated an MFS from local treatment of 136 months in the apalutamide arm and 110 months in the placebo arm, and an estimated OS of 169 months and 154 months, respectively.
The ARAMIS trial evaluated darolutamide (Nubeqa) and demonstrated an MFS of 126.6 months in the study-drug arm and 102.6 months in the placebo arm, while OS was not reached. "Our results are in line with the estimated OS in the SPARTAN and ARAMIS trials," Marshall's group observed.
seems to conflict with RADAR. But if you boil RADAR down, it appears to base the whole "substantial benefit" conclusion on 20 guys that died that only took 6 months vs. 18 months. that's my reading. its a simplification of course
yes, always leery of small numbers of endpoints!!! the problem with so many PCa studies IMHO. Feel better about the Covid vaccine trials..at least for short-term outcomes? Real world now rpoving the validity of those trials!
Back in 2004 it was clear from the literature that ADT was never curative & was therefore of palliative value only. I was 56 and the boilerplate intro to most study papers claimed that the majority of men became "refractory" to ADT within 18-24 months. What, therefore, was the point of early ADT for me?
Doctors had somehow fooled themselves into believing there was benefit - when they were able to charge $1,000 for giving a monthly injection, but when Medicare put an end to that, there was less enthusiasm.
I had PSA persistence after RP & salvage radiation (0.3 followed by 0.8 three months later.) Imaging, such as it was back then, did not show mets. I assumed that Lupron was in my future, so I looked for ways to slow progression & put off the evil day. I didn't have the distraction of today's wonder drugs.
The issue with preemptive ADT is that CRPC (which is expected) is hard to manage. There was no Plan B, other than lackluster Taxotere.
Over the years I have heard men say "Hit it hard.", but why select for cells that cannot be managed?
Of course, ADT in combination with a second therapy is another matter - provided it is not another androgen receptor axis targeted drug.
IMO, ADT monotherapy should be saved for palliation.
Some will say: "But the cancer will keep growing!" Yes it will, but it will not be CRPC. And, IMO, one can slow progression by controling inflammation, aberrant coagulation, etc.
Delaying ADT increases QoL too.
I never did get to try Lupron, although I have been usind DES for almost 3 years (as part of a BAT approach). As of the end of July I did not have CRPC. Until something better comes along, avoiding CRPC should be a major goal. IMO
Yes, Dr.Walsh seems to be reluctant to prescribe ADT just because of some rise in PCa, and he posits that it is cancerous cells that have been there from the beginnng, slow growing initially and non-testosterone dependent, that eventuaally cause the aggressive progression of the cancer. Yes to ADT upon detection of metastasis. Not sure what he advises re any certain doubling time? need to check his book again...he seems quite informed re the progression of PCa!!
anyway, those are actually encouraging numbers for time to metastasis, for those metastasis -free at diagnosis. What methods were used to detect metastasis..standard bone scan, CT, MRI ? Or also PSMA, etc?
I’m with you in thoughts on the ADT conundrum, Patrick. And also on a BAT alternative for HSPC. Using T-cyp 400mg every 2 weeks for two months. Then two months off with no ADT for now while I assess the responses and consider adjusting the timing. So far so good. On third washout cycle now.
Thanks for your story Patrick. This is very helpful as I also had surgery and radiation and salvage ADT with Zytiga.
I completed it all about a year and a half ago and PSA had been undetectable but just popped back at 0.15 last week.
I will get another test in a month to see what happens and hopefully it will be just an aberrant test but if not I’ll be referring back to your article and the studies. Encouraging to see that your results are from 2004!
Agree with puzzling anomaly. Did they not present and have mets diagnosed until they were terminal? And if so did they self-select to not have ADT for all that time? Aramis and the other trials all included ADT even in the control arms. Reading tea leaves to try and compare. Still: there may some glimpse of insight into untreated course of disease after BCR.
Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them.
Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked.
Thinking About “Median Survival” in Clinical Trials. 
Apalutamide for Metastatic Castration-Sensitive Prostate Cancer
How Long Does the FDA’s Real-Time Oncology Review Program Take to Approve New Drug Applications?
