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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06120491 | Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents | PHASE3 | ACTIVE NOT_RECRUITING | 1,889 | — | — | Nov 21, 2023 | Apr 30, 2031 | May 27, 2026 | 322 | United States, Australia +22 |
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Saruparib (AZD5305) + Physician's Choice NHA | EXPERIMENTAL | Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide) |
| Arm 2: Placebo + Physician's Choice NHA | PLACEBO_COMPARATOR | Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide) |
| Name | Type | Description |
|---|---|---|
| Saruparib | DRUG | Oral |
| Placebo | DRUG | Oral |
| Abiraterone Acetate | DRUG | Oral |
| Darolutamide | DRUG | Oral |
| Enzalutamide | DRUG | Oral |
Inclusion Criteria: * Male ≥ 18 years of age. * Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible. * Meta...