Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
Running, not enrolling · Phase 2
Conditions studied: Prostate Cancer
In brief
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).
Key facts
- Study ID
- NCT04422132
- Run by
- Weill Medical College of Cornell University
- People needed
- 134
- Starts
- 2020-09-24
- Expected to finish
- 2033-12-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.
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.
Where it is running
- Weill Cornell Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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