Actively Recruiting
Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer
Led by Weill Medical College of Cornell University · Updated on 2026-01-26
50
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine
New York, New York, United States, 10065'
Actively Recruiting
Research Team
F
Fabiana Gregucci, M.D.
CONTACT
D
Dakota Trick
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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