Table 2 Active clinical trials evaluating pharmacotherapy at BCR after primary treatment.
Study phase | Therapy | Estimated (actual) enrollment | Comparator | Primary endpoint | Estimated completion date | NCT |
|---|---|---|---|---|---|---|
2 | Apalutamide + ADT + sEBRT, docetaxel | 40 | None | PFS at 36 mo | Completed | NCT03311555 |
2 | RV001V | 180 | Placebo | Time to PSA progression (up to 3 yr) | November 2022 | NCT04114825 |
2 | Enzalutamide + sEBRT | 96 | sEBRT + placebo | Freedom from PSA progression (assessed 2 yr from end of therapy) | December 2023 | NCT02203695 |
3 | Apalutamide + LHRH analog, apalutamide, abiraterone + prednisone, LHRH analog | 504 | LHRH analog (degarelix or leuprolide + bicalutamide) | PSA PFS up to 36 mo | January 2024 | NCT03009981 |
2 | Olaparib, durvalumab | 32(5)a | None | Number of participants with an undetectable PSA (assessed after 1 yr) | February 2024 | NCT03810105 |
Olaparib | 50b | None | Response rate as measured by 50% decline in PSA from baseline (assessed after 4 wk) | February 2024 | NCT03047135 | |
2 | pTVG-HP, nivolumab, GM-CSF | 41(19) | None | Percentage of pts within acceptable toxicity boundaries (up to 48 wk); PSA CR rate (up to 48 wk) | January 2025 | NCT03600350 |
2 | GnRH + bicalutamide + sEBRT, GnRH + abiraterone + apalutamide + prednisone + sEBRT | 345 | None | PSA PFS at 2 yr | December 2025 | NCT03141671 |
2 | Nivolumab | 15c | None | Percentage of pts with a ≥ 50% decline in PSA (up to 6 mo post-intervention) | January 2025 | NCT04019964 |
2 | Nivolumab | 34 | None | Proportion of pts with high-risk BCR that experiences PSA decline or stabilization after 12 wk of treatment | March 2025 | NCT03637543 |
2 | Pactritinib | 46 | None | Number of pts with 6-mo PSA PFS | June 2026 | NCT04635059 |
2 | sEBRT + ADT for 24 mo (triptorelin) | 394 | sEBRT + ADT for 6 mo (triptorelin) | MFS at 5 yr | February 2029 | NCT04242017 |
2 | Enhanced ADT (enzalutamide + GnRH analog) + EBRT | 242 | Standard ADT (GnRH analog ± bicalutamide) + sEBRT | PFS (assessed up to 5 yr) | September 2029 | NCT03809000 |
3 | Apalutamide + LHRH + EBRT | 490 | LHRH + EBRT | PFS at 5 yr | December 2033 | NCT04181203 |
