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

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · May 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat high-risk prostate cancer using advanced imaging technology called PSMA PET/MR to guide a type of radiation therapy known as Stereotactic Body Radiation Therapy with Simultaneous Integrated Boost (SBRT-SIB). The goal is to see how effective this treatment is for men with specific types of prostate cancer that have a higher risk of spreading. The trial is looking to enroll 50 male participants aged 21 and older who have been diagnosed with high-risk or unfavorable intermediate-risk prostate cancer.

To be part of this trial, participants must have a confirmed diagnosis of high-risk prostate cancer, meet certain medical criteria, and agree to use effective birth control during the study. They should not have any evidence of cancer spreading beyond the prostate. If eligible, participants can expect to receive the new treatment and be closely monitored throughout the study. It’s important to note that this trial is currently recruiting patients, so those interested should talk to their healthcare provider about the potential benefits and risks of participating.

Gender

MALE

Eligibility 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