๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
๐
What it tests
- PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC
- Stereotactic Body Radiation Therapy (SBRT)
Weill Cornell Medicine
New York, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.