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ACTIVE NOT RECRUITING
NCT04984343
PHASE2

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

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

The study is a randomized study that compares 5 radiation therapy treatments to 2 radiation therapy treatments in men with low or intermediate-risk prostate cancer.

Official title: Randomized Phase II Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2022-02-11

Completion Date

2028-12-31

Last Updated

2025-05-21

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Radiation Therapy

Eligible subjects will be randomly assigned to 5 or 2 fraction treatment groups in a 1:1 ratio using a computer-generated randomization scheme. After consent and eligibility verification, patients will undergo CT/MRI simulation and radiotherapy planning. Patients will receive treatment to the prostate +/- seminal vesicles per treating physician's discretion in either 37.5 Gy in 5 fractions or 25 Gy in 2 fractions. SIB use is at treating physician's discretion and should be concordant with imaging and biopsy findings with no PTV expansion. Subjects on 5 fraction arm should be treated on non-consecutive days. Subjects on the 2 fraction arm must have \>72 hours between beginning of each fraction.

Locations (2)

Weill Cornell Medicine

New York, New York, United States

Genesis Care

Oxford, United Kingdom