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NRG-GU013: The Phase III `High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer

Clinical Trial Details

 The purpose of this study is to compare two radiation treatment schedules: one delivers a higher dose of radiation per treatment for fewer treatments over a shorter length of time (SBRT); the other delivers a lower dose of radiation per treatment but for more treatments over a longer time. Short duration radiation therapy instead of the usual treatment could prevent your cancer from coming back.

Participants will be randomized into one of two treatment groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Group 1 will receive the study approach, which is fewer radiation treatments given at a higher dose. Participants will receive this radiation therapy, every other weekday, for up to 2 weeks, for a total of 5 treatments. 

Group 2 will receive the usual radiation therapy used to treat this type of cancer, which is more radiation treatments given at lower dose. Participants will receive radiation therapy, 5 days a week for 4 -9 weeks for a total of 20 to 45 treatments.

After completing radiation treatment, participants will continue to be monitored and watched for side effects. The study team will check participants every 6 months for a total of 5 years and then switch to yearly checks.

Study participation also consists of study visits, quality of life surveys, and optional sample/biospecimen collections.

Key Eligibility: 
  1. Open to men 18 and older who have a proven diagnosis of adenocarcinoma of prostate cancer
  2. No prior radiotherapy to the region of the study cancer 
  3. No prior radical prostatectomy. 

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

Study contact by location

Queens

Contact(s)

Charlotte Fong
718-660-1716
ccf4001@med.cornell.edu

Brooklyn

Contact(s)

Kate Santoso
929-470-9507
bnk9002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2502028598

ClinicalTrials.gov:

NCT05946213

Sponsor:

NRG-GU013

Status

Not Yet Recruiting

Age Group

Adult

Sponsor

Disease