Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04422132
Sponsor: Weill Medical College of Cornell University
Phase: Phase 2
Eligibility:
- Age: minimum 18 Years maximum 90 Years
- Gender: Male
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.
View trial on ClinicalTrials.gov