NCT05079698

A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer

A Safety Study of Stereotactic Body Radiotherapy (SBRT) and 177Lu-PSMA617 for the Treatment of Hormone Sensitive, Oligometastatic Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to find out whether giving 177Lu-PSMA-617 followed by a type of radiation therapy called SBRT (stereotactic body radiation therapy) is a safe treatment for your cancer. The study agent has been shown to target tumor cells, and the researchers think that adding 177Lu-PSMA-617 to SBRT may prevent or delay the cancer from continuing to spread.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	177Lu-PSMA-617	Intravenous (IV) infusion of 177Lu-PSMA-617 on Day 1 of treatment Cycles 1 and 2. PSMA PET utilizing either the 68Ga-PSMA-11 or 18F-DCFPyL tracer is acceptable. Patients should be restaged using the same tracer which was utilized to establish initial eligibility for the trial.
PROCEDURE	Stereotactic Body Radiotherapy (SBRT)	No later than 5 weeks (+/- 7 days) after the 2nd cycle of 177Lu-PSMA-617, patients will then undergo SBRT (900 cGy x 3 fractions).

Timeline

• Start date: 2021-10-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2021-10-15
• Last updated: 2026-04-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study