STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 13, 2025

Primary Completion Date

September 11, 2025

Study Completion Date

September 11, 2026

Conditions
Malignant Neoplasm of ProstateLocally Advanced Prostate Cancer
Interventions
DRUG

Lu-PSMA-617

"Lu-PSMA will be administered at a fixed dose of 7.4GBq per cycle, on a dose escalation schedule:~* Level 0: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT.~* Level 1 (Starting Dose Level): Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2.~* Level 2: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2, followed 6 weeks later by cycle 3."

RADIATION

5-fraction Stereotactic Body Radiation Therapy (SBRT)

Prostate and nodal SBRT will begin at the completion of cycle 1 (6 weeks after the first Lu-PSMA-617 infusion, ± 4 weeks).

Trial Locations (1)

44106

RECRUITING

University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Angela Y. Jia, MD PhD

OTHER