Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer
Recruiting now · Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT04402151
- Run by
- Weill Medical College of Cornell University
- People needed
- 50
- Starts
- 2020-06-30
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-01-26
Who can join
Age: 21 and older, up to 90. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Weill Cornell Medicine — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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