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

NCT05079698 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-04-07

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Brandon Imber, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2027-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05079698 on ClinicalTrials.gov