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

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Conditions

Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2020-06-30
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04402151

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.

Ages Eligible for Study:21 Years to 90 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male aged 21 years or older.
  2. * Ability to provide signed informed consent and willingness to comply with protocol requirements.
  3. * 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)
  4. * 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.
  5. * No evidence of metastatic disease, including pelvic lymph nodes.
  1. * Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MR.
  2. * Contraindications to PSMA IV administration
  3. * 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)
  4. * Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment
  5. * Patients on or intending to take abiraterone will be excluded

Contacts and Locations

Study Contact

Sharanya Chandrasekhar, M.S.
CONTACT
646-962-2196
shc2043@med.cornell.edu
Pragya Yadav, Ph.D.
CONTACT
646-962-2199
pry2003@med.cornell.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-30
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-06-30
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer