RecruitingPhase 2NCT06200103

Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Minority-Inclusive Imaging Biomarker-Based End of Therapy Trial for 177Lu-PSMA-617, a Randomized De-Escalation Theranostic Trial for Metastatic Castrate Resistant Prostate Cancer


Sponsor

Mayo Clinic

Enrollment

236 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how to improve the usage of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen \[PSMA\]-617) for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site), to other places in the body (metastatic) utilizing a treatment pause after 5 cycles of therapy versus standard continuous treatment for 6 cycles. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic castrate resistant prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether reducing the frequency of lutetium-177 PSMA-617 (a radioactive drug that targets prostate-specific membrane antigen) from the standard 4 doses to fewer doses can maintain effectiveness while reducing side effects in men with advanced prostate cancer. **You may be eligible if...** - You are being treated at Mayo Clinic Rochester - You have metastatic castration-resistant prostate cancer (cancer that has spread and is no longer responding to hormone therapy) - Your tumor tests positive for PSMA on a PET scan (miPSMA score ≥2) - You are scheduled to receive 177Lu PSMA-617 therapy **You may NOT be eligible if...** - You do not have PSMA-positive disease on PET scan - Your prostate cancer is not castration-resistant - You are not being treated at Mayo Clinic Rochester 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

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

OTHERClinical Observation

Undergo active monitoring

PROCEDUREComputed Tomography

Undergo SPECT/CT or PET/CT

OTHERGallium Ga 68 Gozetotide

Given IV

DRUGLutetium Lu 177 Vipivotide Tetraxetan

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06200103


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