Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
Prostate Carcinoma
About this trial
This is an interventional treatment trial for Prostate Carcinoma
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Histological confirmation of prostate cancer Planned definitive dose radiotherapy to the prostate Note: Patients are eligible for enrollment if they are already enrolled or planned for enrollment on another interventional research protocol provided that other study protocol treatment does not require procedures or treatments that would be in conflict with the eligibility or treatment protocols for this study nor, in the judgement of the enrolling physician, affect primary study objectives of this study Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 Ability to complete questionnaire(s) by themselves or with assistance Provide written informed consent Exclusion Criteria: Planned delivery of radiotherapy to pelvic lymph nodes Planned brachytherapy treatment of the prostate Significant urinary incontinence that precludes standard bladder filling Evidence of direct bladder extension or bladder wall metastases from prostate cancer Used indwelling or intermittent urinary catheterization at baseline Prior pelvic radiotherapy such that any portion of the prostate received > 5 Gy
Sites / Locations
- Mayo Clinic in Arizona
- Mayo Clinic in FloridaRecruiting
- Mayo Clinic Health System in Albert LeaRecruiting
- Mayo Clinic Health Systems-MankatoRecruiting
- Mayo Clinic in RochesterRecruiting
- Mayo Clinic Health System-Eau Claire ClinicRecruiting
- Mayo Clinic Health System-Franciscan HealthcareRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (bladder filling, CT, radiation)
Arm II (bladder emptying, CT, radiation)
Patients perform SOC bladder filling and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.
Patients perform bladder emptying and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.