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Decipher risk: prostatectomy RP vs radiation.
Prostate Cancer | Last Active: 6 days ago | Replies (75)Comment receiving replies
@brianjarvis
The Arches trial was where they compared ADT to ADT plus Enzalutamide. One Group only got ADT and a placebo. Not a very good trial for somebody that has a serious case of prostate cancer and doesn’t get both drugs.
The stampede trial did the same thing with ADT and abiraterone.
Both of these trials would be a very bad idea for somebody with a serious prostate cancer case.
This was discussed a lot in ancan.org meetings. People came in that were interested in doing those trials and were advised not to when they had serious cases that called for both drugs.
Replies to "@brianjarvis The Arches trial was where they compared ADT to ADT plus Enzalutamide. One Group only..."
@jeffmarc We know that now. But at the time, Enzalutamide (Xtandi; an ARPI) + ADT had only been approved for metastatic and nonmetastatic HRPC. The purpose of the ARCHES trial was to determine the efficacy and safety of enzalutamide + ADT in mHSPC.
So yes, it made very good sense to have both groups use what was then standard of care (SOC) for mHSPC to both receive ADT; then to have one group “add-on” Enzalutamide to the ADT and the other group to “add-on” a placebo to the ADT (both groups at least getting SOC).
Actually, it was a very good “add-on” trial. What they found was that Enzalutamide with ADT significantly reduced the risk of metastatic progression over time versus placebo plus ADT in men with mHSPC, consistent with the results of enzalutamide plus ADT in previous clinical trials in HRPC.
The discussions that occurred in the AnCan group, were those of desperate men who would have tried and done anything in their circumstances. The purpose of a well-run “add-on” clinical trial is to first determine the efficacy and safety of a drug combination, and then to move forward from there.
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@jeffmarc
I know in some medical trials, they then offer the placebo group the drug if results are promising. However, that clearly is not an option with this treatment protocol of combination therapy.