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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05670106 | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC | PHASE2 | COMPLETED | 62 | — | — | May 16, 2023 | Apr 22, 2026 | Jun 8, 2026 | 17 | China |
| NCT05658003 | A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 63 | — | — | May 5, 2023 | Jan 13, 2027 | Mar 23, 2026 | 15 | China |
Confirmed Overall Response Rate (ORR) is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR is based on PCWG3-modified RECIST v1.1 response for patients with measurable disease at baseline.
Radiographic progression free survival (rPFS) is defined as the time of radiographic progression by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST V1.1 as assessed by blinded independent central review, or death.
| Arm | Type | Description |
|---|---|---|
| [177Lu]Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) | EXPERIMENTAL | Patients will receive the investigational product 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) may be used |
| [177Lu]Lu-PSMA-617 | EXPERIMENTAL | Participants will receive 7.4 GBq (200 mCi) +/- 10% \[177Lu\]Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT may be used. |
| Androgen receptor-directed therapy (ARDT) | ACTIVE_COMPARATOR | For participants randomized to the ARDT arm, the change of ARDT treatment will be administered per the physician's orders. Best supportive care, including ADT may be used. |
| Name | Type | Description |
|---|---|---|
| [177Lu]Lu-PSMA-617 | DRUG | Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles. |
| Best supportive/best standard of care (BS/BSOC) | OTHER | Best supportive/best standard of care as defined by the local investigator |
| 68Ga-PSMA-11 | DRUG | Administered single intravenous dose of approximately 150 MBq. Administered dose could not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi). |
| ARDT | DRUG | administered orally on a continuous basis, as per package insert and guidelines |
| [68Ga]Ga-PSMA-11 | DRUG | single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi). |
| Best supportive care | OTHER | Best supportive/best standard of care as defined by the local investigator |
Inclusion Criteria: * Written informed consent must be obtained before any assessment is performed. * Participants must be Chinese male adults \>= 18 years of age. * Participants must have histological, pathological, and/or cytological confirmation of prostate cancer. * Participants must be \[68Ga\...