RecruitingPhase 1Phase 2NCT06574880

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

STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I/II Trial

Sponsor

Angela Y. Jia, MD PhD

Enrollment

45 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

Malignant Neoplasm of Prostate Locally Advanced Prostate Cancer

Summary

The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer. Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of stereotactic body radiation therapy (SBRT — a precise, high-dose form of radiation) with a radioactive drug called lutetium-177 PSMA (which targets prostate cancer cells that express the PSMA protein) for men with locally advanced prostate cancer that has spread to nearby lymph nodes. **You may be eligible if...** - You are 18 or older - You have been confirmed to have prostate adenocarcinoma - Your cancer shows up strongly on a PSMA PET/CT scan (SUVmax ≥ 10 in the prostate) - Your cancer has spread to pelvic or regional lymph nodes on PSMA PET/CT or conventional imaging - Your performance status is good (ECOG ≤ 1) **You may NOT be eligible if...** - Your cancer does not show up well on PSMA PET/CT - You have serious organ problems or other active cancers - You are not eligible for the hormone therapy component 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

DRUGLu-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.

RADIATION5-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).

Locations(1)

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

Cleveland, Ohio, United States

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NCT06574880

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