NCT04422132Active, not recruitingPhase 2
Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 137 (actual)
- First submitted
- 5 Jun 2020
- Start date
- 24 Sept 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Prostate cancer
- NCT number
- NCT04422132
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 137
- From 24 Sept 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of receiving pelvic radiotherapy.
- 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.
Other illness
- Patient with inflammatory bowel disease.
- History of bladder neck or urethral stricture.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.