Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate… (NCT04197141) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer
Canada58 participantsStarted 2020-02-07
Plain-language summary
The purpose of this research study is to determine if 5 (five) fractions of external radiotherapy with higher radiation doses per fraction to the pelvis leads to similar results to the standard of care external radiotherapy treatment that is comprised of 25 fractions of external radiotherapy with lower radiation doses per fraction to the pelvis.
This study aims to investigate the impact in quality of life associated with hypofractionated Whole Pelvis Radiotherapy (WPRT) in comparison to conventionally-fractionated WPRT in patients with unfavorable-intermediate and high-risk prostate cancers. This information is valuable as hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if proven to be well-tolerated and effective. Therefore, this study aims to provide a more rational justification for use of hypofractionated WPRT in future larger randomized trials by comparing this strategy with the current standard of care. This study will also provide an initial understanding of the toxicity profile and cancer control associated with hypofractionated WPRT and High Dose Rate Brachytherapy (HDR-BT).
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* Study Informed Consent provided
* Pathologically proven diagnosis of prostatic adenocarcinoma
* Unfavorable intermediate risk \[with greater than 15% chance of node involvement based on Memorial Sloan Kettering Cancer Center (MSKCC) nomogram https://www.mskcc.org/nomograms/prostate\] or high or very-high-risk prostate cancer based on National Comprehensive Cancer Network (NCCN) classification \[Prostatic Specific Antigen (PSA) \> 20 ng/mL or clinical cT3a or cT3b or Gleason 8-10\]
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* No prior history of pelvic irradiation, brachytherapy, cryosurgery, High-Intensity Focused Ultrasound (HIFU), Transurethral Resection of the Prostate (TURP) or radical prostatectomy
Exclusion Criteria:
* Presence of nodal or distant metastasis, as confirmed by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) of the chest/abdomen/pelvis and bone scan within 45 days of randomization
* Plan for adjuvant docetaxel post-radiotherapy
* Serious medical comorbidities or other contraindications to HDR-BT
* Presence of inflammatory bowel disease
* Presence of connective tissue disease
* Medically unfit for general anesthesia
* Unable or unwilling to complete questionnaires
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two different radiation schedules for treating the whole pelvis — can you explain how the hypofractionated schedule, which uses fewer but larger doses, differs from the conventional schedule, and what that difference might mean for my specific situation?
2Since this is a Phase 2 trial, what does that mean in terms of how much is already known about the safety and long-term effects of delivering radiation to the whole pelvic area in this way?
3The trial's main focus is on measuring late bowel function using something called the EPIC questionnaire — what kinds of bowel side effects should I realistically be prepared for with whole-pelvis radiotherapy, and how might those affect my daily life?
4The trial is no longer enrolling new patients — does that mean there are other similar approaches or studies I could explore, or would standard conventionally-fractionated radiation to the pelvis be a better option for me right now?
5Given that this study is actively running and collecting long-term quality-of-life data, is there anything about my current health or bowel function that might make one of these radiation schedules a better or worse fit for me than the other?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire
Timeframe: I year post treatment (approximately 3 years and 2 months)
Trial details
NCT IDNCT04197141
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's