Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This is a single-arm Phase II clinical trial assessing the clinical efficacy of prostate specific membrane antigen (PSMA) PET/MR guided MR-LINAC based SBRT-SIB with planned accrual of 50 patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Male aged 21 years or older.

• Ability to provide signed informed consent and willingness to comply with protocol requirements.

• Pathologic confirmation of high-risk adenocarcinoma of the prostate gland as follows:

a. Gleason 8-10 or tertiary component 5 disease and/or b. PSA of 20 ng/ml or greater and/or c. Tumor stage of T2c or greater; OR Unfavorable intermediate risk (Gleason 4+3=7, >50% of cores involved, or 2 or more intermediate risk factors which include Gleason 7 disease, PSA 10-20, or T2b disease)

• Participants must agree to use an acceptable form of birth control and utilize condoms for a period of seven days after each PSMA injection, if engaged in sexual activity.

• No evidence of metastatic disease, including pelvic lymph nodes.

Exclusion Criteria:

• Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MR.

• Contraindications to PSMA IV administration

• Contraindications to prostate SBRT (history of transurethral resection of prostate; prostate size greater than 150 cc; AUA score greater than 20; history of prior radiation to the prostate)

• Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment

• Patients on or intending to take abiraterone will be excluded