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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06526299 | Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease | PHASE2 | RECRUITING | 51 | — | — | Apr 29, 2025 | Dec 31, 2027 | Mar 24, 2026 | 3 | United States |
PSA progression is defined as a rise in PSA at \> 12 weeks by more than 25% and more than 2ng/mL above the nadir (lowest PSA point). Time-to-event endpoints will be analyzed graphically and numerically using the Kaplan-Meier method and summarized in terms of median or 1-year survival point estimates with corresponding 95% confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Treatment (177Lu-PSMA-617) | EXPERIMENTAL | Patients receive 177Lu-PSMA-617 IV over 30 minutes on days 1, 8, 50, 57, 99 and 141. Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle 2 and subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA-PET/CT during screening and SPECT/CT on study. Patients also undergo CT or MRI, bone scan, as well as blood sample collection throughout the study. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Scan | PROCEDURE | Undergo bone scan |
| Computed Tomography | PROCEDURE | Undergo SPECT/CT and CT |
| Lutetium Lu 177 Vipivotide Tetraxetan | DRUG | Given IV |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| PSMA PET-CT Scan | PROCEDURE | Undergo PSMA PET/CT |
| Questionnaire Administration | OTHER | Ancillary studies |
| Single Photon Emission Computed Tomography | PROCEDURE | Undergo SPECT/CT |
Inclusion Criteria: * Patients must have the ability to understand and sign an approved informed consent. * Patients must have the ability to understand and comply with all protocol requirements. * Patients must be ≥ 18 years of age. * Patients must have an Eastern Cooperative Oncology Group (ECOG)...