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Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer

Clinical Trial Details

This is a randomized study comparing 5 radiation therapy treatments to 2 radiation therapy treatments with MRI guidance in patients with prostate cancer. The study will assess the potential benefit of limiting radiation doses received by normal tissues, namely the bladder and the rectum, with advanced MRI image guidance and to compare urinary and bowel side effects between the two treatment options.  Prostate cancer cure and control and quality of life will also be examined. 

Learn more about the trial details in this informational video:

This is one of the only Phase II randomized trials in the world exploring 2 fraction treatment in the definitive setting with MRI-based planning and treatment and it lays the foundation to potentially redefine the standard of care to include 2 fraction radiotherapy treatment. The potential advantages of further decreasing treatment burden with 2 treatment radiotherapy are: 
  • Increase convenience to patients because of fewer treatment days,
  • Increase access for patients to radiotherapy because of fewer treatment days,
  • Reduced cost to patients because of fewer travel expenses and copays,
  • Improved resource utilization for physicians because fewer number of treatments per patient and overall,
  • Reduced cost to society.

There is no guarantee that patients will receive any benefits from this study. Common side effects of radiotherapy include mild pain, tiredness, diarrhea, increased urinary frequency, and erectile dysfunction. Participants may experience all, some, or none of the side effects listed, as well as other more occasionally experienced side effects. Associated risks from radiotherapy will be carefully discussed prior to participation.

Participants will be randomized into one of the study groups by chance: 5 treatments or 2 treatments. Randomization is like flipping a coin and neither the participant nor the researchers will choose the groups.

Study participation will last approximately 5 years with regular follow ups every 3 months for the first 2 years and again after completion of the study. Participants will also undergo physical exams, routine blood testing, scans, and provide urine samples as an ongoing part of the study.

Key Eligibility: 
  • Men over the age of 18 with histologically confirmed low or intermediate-risk prostate cancer per NCCN guidelines. 
  • Ability to receive MRI-guided radiotherapy.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Sharanya Chandrasekhar
(646) 962-2196
shc2043@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2102023315

ClinicalTrials.gov:

NCT04984343

Sponsor:

21-02023315

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease