Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks

February 23, 2026 updated by: Weill Medical College of Cornell University
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The standard treatment for most patients with biochemical recurrence after radical prostatectomy is salvage radiotherapy. Salvage radiotherapy delays the need for chronic, non-curative treatment, such as long-term androgen suppression, and is the only potentially curative treatment of some biochemical recurrences after prostatectomy.

Patients are recommended to undergo salvage radiotherapy to eradicate biochemical disease delivered in approximately 40 treatments over the course of 8 weeks, representing a high burden of therapy, which may be related to lower utilization of salvage radiotherapy. Modern radiotherapy for prostate cancer has been afforded many advantages including advanced image-guided radiotherapy allowing for larger dose delivery in fewer treatments and smaller margins with hypofractionated (20 treatments) and ultra-hypofractionated (5 treatments) radiotherapy.

In patients that need salvage radiotherapy, the potential advantages of hypofractionated and ultra-hypofractionated radiotherapy delivered over 20 or 5 treatments are: 1) increased convenience to patients because of fewer treatment days, 2) reduced costs to patients because of reduced travel expenses and copays, 3) improved resource utilization for physicians because of the fewer number of treatments per patient and consequently 4) reduced cost to society. In prostate cancer specifically, hypofractionated and ultra-hypofractionated radiotherapy has the added potential of not increasing toxicity with shorter treatment times.

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
  • KPS >=70
  • Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan < 9 months prior to enrollment. Patients with positive pelvic lymph nodes are eligible.
  • Ability to receive MRI-guided radiotherapy.
  • Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy.
  • Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

Exclusion Criteria:

  • Prior history of receiving pelvic radiotherapy.
  • Patient with inflammatory bowel disease.
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy.
  • History of bladder neck or urethral stricture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ARM 1 - 2 weeks
Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days.
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.
Active Comparator: ARM 2 - 4 weeks
Patients will receive treatment to the prostate fossa +/- nodes in 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
Time Frame: Baseline, 1 month, 24 months

The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC.

Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Baseline, 1 month, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the number of patient reported GI-GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
Time Frame: 3 months, 6 months, 12 months, 24 months, 60 months

Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.

Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.

Adverse events can be unexpected or expected, related to treatment.
3 months, 6 months, 12 months, 24 months, 60 months
Time to progression (TTP)
Time Frame: 3 months, 6 months, 12 months, 24 months, 60 months
Compare time to progression (TTP) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).
3 months, 6 months, 12 months, 24 months, 60 months
Overall survival (OS)
Time Frame: 3 months, 6 months, 12 months, 24 months, 60 months
Overall survival (OS) will be measured among the participants
3 months, 6 months, 12 months, 24 months, 60 months
Number of patients who expired due to prostate cancer.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Viewray Inc.

Investigators

  • Principal Investigator: Emily Weg, M.D., Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-03021572

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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