Ultra-Hypo vs Conventional IMRT for Prostate Cancer
(PCS-XI Trial)
Trial Summary
What is the purpose of this trial?
Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Ultra-Hypo vs Conventional IMRT for Prostate Cancer?
Research shows that high-dose-rate brachytherapy (HDR-BT) and ultrahypofractionated radiation therapy, like stereotactic body radiotherapy (SBRT), are effective in treating prostate cancer by delivering higher doses of radiation in fewer sessions, which can improve outcomes without increasing side effects.12345
Is Ultra-Hypo Fractionated Radiotherapy safe for prostate cancer treatment?
Ultra-Hypo Fractionated Radiotherapy (UHF) for prostate cancer has been studied for safety, showing that lower doses (L-UHF) have a good balance between safety and effectiveness, with fewer side effects compared to higher doses (H-UHF). However, higher doses can lead to more gastrointestinal and urinary side effects.14678
How does Ultra-Hypo Fractionated Radiotherapy differ from other prostate cancer treatments?
Ultra-Hypo Fractionated Radiotherapy (UHF) for prostate cancer is unique because it delivers higher doses of radiation in fewer sessions compared to conventional methods, potentially reducing treatment time while maintaining similar effectiveness and safety. This approach combines Intensity-Modulated Radiation Therapy (IMRT) with a High-Dose Rate Brachytherapy (HDR-BT) boost, which allows for precise targeting of the cancer with minimal impact on surrounding healthy tissue.1591011
Research Team
Andre-Guy Martin, MD MSc FRCPC
Principal Investigator
Andre-Guy Martin MD Inc.
Eligibility Criteria
This trial is for men with a specific type of prostate cancer that hasn't spread to other parts of the body. They should be at an intermediate to very high risk according to NCCN guidelines and have not had pelvic radiotherapy before. Men with autoimmune diseases like Lupus, past inflammatory bowel disease, advanced prostate cancer (stage M1), severe urinary symptoms even on medication, or bilateral hip replacements cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either ultra-hypo fractionated radiotherapy (5 Gy/fraction) over 2 weeks or standard fractionation (1.8-2.15 Gy/fraction) over 4-5 weeks, combined with HDR brachytherapy and ADT
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments every 3 months for 1 year, then every 6 months up to 36 months, and annually up to 10 years
Long-term Monitoring
Long-term monitoring of testosterone levels and other health metrics to assess disease-free survival and overall survival
Treatment Details
Interventions
- Conventionally Fractionated IMRT with HDR Boost
- HDR Prostate +/- Adjacent Seminal Vesicles Brachytherapy Boost (HDR-BT)
- Pelvic Nodes Ultra-Hypo Fractionated Radiotherapy (UHF)
Conventionally Fractionated IMRT with HDR Boost is already approved in United States, European Union, Canada, Japan for the following indications:
- Prostate cancer
- Prostate cancer
- Prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
CHU de Quebec-Universite Laval
Lead Sponsor
TerSera Therapeutics LLC
Industry Sponsor