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

Description

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

Prostate Cancer

Study Overview

Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10065'

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

21 Years to 90 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Silvia Formenti, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2025-12-31