Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05189457 | First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 32 | — | — | Jan 25, 2022 | Jul 1, 2028 | Dec 4, 2025 | 1 | United States |
Overall survival will be from initiation of first strike until failure or death from any cause.
| Arm | Type | Description |
|---|---|---|
| First Strike then Second Strike | EXPERIMENTAL | The first part of the study treatment or "first strike" involves 12-18 weeks of combined therapy with LHRH analog and one of the new hormonal agents (NHAs). Participants will complete the "first strike" at week 13 if their PSA has reduced \>90%; otherwise they will complete a total of 18 weeks of therapy. The second part of the treatment or "second strike" involves 4 cycles docetaxel and LHRH analog. The "second strike" will start immediately after the "first strike". MRI guided prostate biopsy will be performed after "second strike". For patients with positive prostate biopsy or detectable PSA, the "second strike" will be consolidated with 4-6 additional cycles of docetaxel plus 6 doses of tislelizumab at 200 mg, given IV once every 3 weeks. For patients with undetectable PSA at year 3 from study enrollment, LHRH analog can be discontinued. |
| Name | Type | Description |
|---|---|---|
| Luteinizing Hormone Releasing Hormone | DRUG | During the first strike, LHRH will be administered for 12 to 18 weeks. During the second strike, participants will receive 4 cycles of LHRH |
| New Hormonal Agent | DRUG | During the first strike, if Abiraterone is chosen 1000mg of Abiraterone will be taken orally. If Enzalutamide is used, 160 mg will be taken orally every 24 hours. |
| Docetaxel | DRUG | During the second strike, participants will receive 4 cycles of Docetaxel at 75mg/m2 given intravenously at day 1 of ever 21 days. For participants with positive prostate biopsy or detectable PSA, the "second strike" will receive 2 additional cycles of docetaxel. |
| Tislelizumab | DRUG | During the second strike, participants will receive 6 doses of Tislelizumab at 200 mg, given intravenously once every 3 weeks. |
Inclusion Criteria: * Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion. High risk mCSPC is defined as having 2 of the 3 risk factors: a Gleason score of 8 or more, at least 3 bone metastases, and the presence of measu...