Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
177Lu-PSMA-617 · 3 trials · 3 indications
rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.
Treatment emergent adverse events will be classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events and clinically significant laboratory abnormalities (meeting Grade 3, 4, or 5 criteria according to CTCAE) will be summarized by maximum intensity and relationship to Lu-PSMA-617 and liver-directed therapy (if applicable). Descriptive statistics will be utilized to display the data on toxicity seen. Descriptive summaries of discrete data will present the number of study participants and the incidence as a frequency and a percentage.
ORR is defined as the proportion of treated participants who obtained an radiographic objective response \[confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Proportion and 95% confidence interval will be reported.
| Arm | Type | Description |
|---|---|---|
| 177Lu-PSMA-617 | EXPERIMENTAL | Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used. |
| Androgen receptor-directed therapy (ARDT) | ACTIVE_COMPARATOR | For participants randomized to the ARDT arm, abiraterone or enzalutamide was administered per the physician's orders. Best supportive care, including Androgen deprivation therapy (ADT) could be used. |
| Standard of Care | ACTIVE_COMPARATOR | For participants randomized to Standard of Care arm, ARDT +ADT is considered as SOC and treatment will be administered per the physician's order |
| Treatment (177Lu-PSMA-617) | EXPERIMENTAL | Participants with diffusely PSMA-avid disease will receive standard doses of both 177Lu-PSMA-617 (7.4 Gigabequerel (GBq) every 6 weeks for up to 6 cycles) and transarterial chemoembolization (TACE) and/or ablation. Participants with one or more PSMA-negative liver lesions and PSMA-avid disease at all other sites will be treated with a single session of liver-directed therapy (either TACE or ablation) prior to initiation of 177Lu-PSMA-617 treatment. After cycle 2 of 177Lu-PSMA-617, participants who have extrahepatic stable disease/response but hepatic stable disease or progression per RECIST v1.1 will undergo liver-directed therapy. If clinically indicated and extrahepatic disease remains stable after cycle 3 of 177Lu-PSMA-617, participants may undergo a second course of liver-directed therapy. Participants will continue on study until progressive disease, study completion, unacceptable toxicity, or death. |
| Name | Type | Description |
|---|---|---|
| 177Lu-PSMA-617 | DRUG | administered intravenously once every 6 weeks (1 cycle) for 6 cycles |
| 68Ga-PSMA-11 | DRUG | single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 185 MBq (3 - 5 mCi). |
| ARDT | DRUG | administered orally on a continuous basis, as per package insert and guidelines |
| ADT | DRUG | ADT are administered as per physician order |
| Ablation | PROCEDURE | Undergo ablation |
| Trans-arterial chemoembolization (TACE) | PROCEDURE | Undergo TACE |
| Positron Emission Tomography (PET)/Computerized tomography (CT) | PROCEDURE | Undergo imaging |
| Tumor Biopsy | PROCEDURE | Undergo biopsy |
| Questionnaire | OTHER | Participant will complete questionnaire |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Participants must be adults \>= 18 years of age. * Participants must have an ECOG performance status of 0 to 1. * Participants must have histological pathological, and/or cytological confirmation o...