RecruitingPhase 1NCT05079698

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

27 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is combining focused radiation (SBRT) to individual metastatic tumors with a radioactive drug called lutetium PSMA-617 (which seeks out prostate cancer cells throughout the body) in men with prostate cancer that has spread to a limited number of sites. **You may be eligible if...** - You have biopsy-proven prostate cancer that has been previously treated with surgery or radiation - Your prostate cancer has spread to 1–5 tumors (oligometastatic) visible on a PSMA PET scan - You have had a PSMA scan within the last 2 months - You have a negative MRI or biopsy showing no cancer remaining in the prostate bed - You have not received any prostate cancer treatment since your PSMA scan **You may NOT be eligible if...** - Your cancer has spread to more than 5 sites - You have previously received lutetium PSMA-617 therapy - Your kidney function or blood counts are inadequate - You have active non-prostate cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-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.

PROCEDUREStereotactic 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).