Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
NCT04422132 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2026-02-27
Summary
The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy. The investigators are also interested in looking at time to progression and the quality of life (health scores).
Conditions
Interventions
- RADIATION
-
5 days Radiation Therapy (32.5 Gy in 5 fractions)
Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.
- RADIATION
-
20 days Radiation therapy (55 Gy in 20 fractions)
Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.
Sponsors & Collaborators
-
Viewray Inc.
collaborator INDUSTRY -
Weill Medical College of Cornell University
lead OTHER
Principal Investigators
-
Emily Weg, M.D. · Weill Medical College of Cornell University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-24
- Primary Completion
- 2025-12-31
- Completion
- 2033-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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