Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
1 other identifier
interventional
134
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Sep 2020
Longer than P75 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
ExpectedFebruary 27, 2026
February 1, 2026
5.3 years
June 5, 2020
February 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
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 Outcomes (4)
Change in the number of patient reported GI-GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
3 months, 6 months, 12 months, 24 months, 60 months
Time to progression (TTP)
3 months, 6 months, 12 months, 24 months, 60 months
Overall survival (OS)
3 months, 6 months, 12 months, 24 months, 60 months
Number of patients who expired due to prostate cancer.
Through study completion, an average of 10 years
Study Arms (2)
ARM 1 - 2 weeks
ACTIVE COMPARATORPatients 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.
ARM 2 - 4 weeks
ACTIVE COMPARATORPatients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.
Interventions
Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weill Medical College of Cornell Universitylead
- Viewray Inc.collaborator
Study Sites (1)
Weill Cornell Medicine
New York, New York, 10065, United States
Related Publications (1)
Marciscano AE, Wolfe S, Zhou XK, Barbieri CE, Formenti SC, Hu JC, Molina AM, Nanus DM, Nauseef JT, Scherr DS, Sternberg CN, Tagawa ST, Nagar H. Randomized phase II trial of MRI-guided salvage radiotherapy for prostate cancer in 4 weeks versus 2 weeks (SHORTER). BMC Cancer. 2023 Aug 22;23(1):781. doi: 10.1186/s12885-023-11278-3.
PMID: 37608258DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Weg, M.D.
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 9, 2020
Study Start
September 24, 2020
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2033
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share