Clinical Trial Considerations??

[CubFan]

I’ve been presented with a clinical trial and I’m open to feedback.

Background: I’m 71 and in pretty good health. I was diagnosed with two Gleason 6 lesions in late 2021 and went on AS. At that point, PSA was in the low 4’s. Earlier this year, PSA rose to 6.7. MRI and guided biopsy uncovered one Gleason 4+4, so my AS days are over. The tumor is small: 3mm long and 14% of the core. PSMA scan indicates no spread.

For treatment, I’ve chosen radiation at UT Southwestern in Dallas. I’m going with 20 sessions of EBRT, 1 session of HD brachy, and 12 months of ADT. (I’ve had 3 ROs discourage SBRT for G8 because its benefits have not yet been evidenced by long-term studies).

There is also an optional clinical trial available. It consists of SBRT and 6 months of hormone therapy. The ADT adds niraparib to the traditional abiraterone, prednisone, and leuprolide mix. Niraparib (a PARP inhibitor) was recently FDA approved for prostate cancer treatment, primarily for men with castration-resistant cancer. It’s been used with cervical and ovarian cancer. This Phase I/II study is to establish the maximum tolerable dose of the drug. It has a pretty lengthy list of side effects in addition to the traditional ADT treatment.

While I want to help the PC cause, the standard treatment plan has a very high likelihood of success even with high-risk G8. The trial uses SBRT and a shorter ADT regimen. But there are a lot of unknowns (that’s why it’s a trial) and more rules and check-ins as part of the program. Given the tradeoffs, I'm pretty doubtful that it's better for me than the EBRT/brachy/ADT approach. Any thoughts on things I may not be considering?

[Tall_Allen]

PARP inhibitors are very toxic and only work well if one has a BRCA mutation.