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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03525288 | PSMA-PET Guided Radiotherapy | PHASE2 | ACTIVE NOT_RECRUITING | 130 | — | — | May 15, 2018 | May 30, 2027 | Mar 13, 2025 | 3 | Canada |
Time to failure event
| Arm | Type | Description |
|---|---|---|
| PSMA-PETgRT | EXPERIMENTAL | PSMA-PET/CT imaging is performed during treatment planning. Treating physicians are informed of test results and advised to include up to 5 PSMA-PET avid sites distant to the prostate gland, if present, in the radiotherapy treatment plan. |
| Standard | ACTIVE_COMPARATOR | Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging. |
| Name | Type | Description |
|---|---|---|
| PSMA -PET/CT simulation | RADIATION | * PET/CT simulation. * If no additional lesions detected: RT as planned per standard care. * If PSMA-PET/CT imaging consistent with oligometastases (1-5 lesions): all lesions must be treated with definitive RT. * If PSMA-PET/CT imaging consistent with widely metastatic disease (\>5 lesions): treatment of all detected disease with RT is not recommended, but treatment of the primary site as initially planned is encouraged. |
| Standard-care simulation | RADIATION | No PSMA-PET/CT as part of RT treatment planning. |
Inclusion Criteria: 1. Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials. 2. Histological diagnosis of prostate cancer planned for curative-intent radiotherapy. 3. ECOG 0-1 4. Charlson Cormobidity Index ≤ 4 5. High-risk of distant metastases as defined by any o...