Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.
Key facts
- Who runs it
- CHU de Quebec-Universite Laval
- Where
- Canada11 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Suspended
- People taking part
- 500 people, planned
- Started
- 1 Sept 2022
- Expected to end
- Dec 2035
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)
- Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):
- Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)
- Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)
- Report and compare the biochemical disease free survival (bDFS)
- Report and compare the disease free survival (DFS)
- Report and compare the metastase free survival (MFS)
- Report and compare the overall survival (OS)
- Record updated
- 12 September 2025
- Why it stopped
- amendment to be done, adding 200 patients
Who can take part
- Age
- 18 years to 95 years
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Histopathologically confirmed adenocarcinoma of the prostate
- All clinical stages with lymph node involvement risk needing pelvis RT
- Stage Mx or M0
- Unfavorable Intermediate, high or very high-risk disease according to NCCN guidelines
- Having the ability to give free and informed consent
Who cannot take part
- IPSS Score > 20 with alpha-blocking medication
- Prior pelvic radiotherapy,
- History of active collagenosis (Lupus, Scleroderma, Dermatomyositis)
- Past history of Inflammatory Bowell Disease
- Clinical stage M1
- Bilateral hip prosthesis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ultra hypo fractionation radiation therapy (UHF)Treatment being tested
5 radiation treatments (5 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given every other day over 2 weeks for a total of 25 Gy.
Treatment: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS), Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):, Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM), Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE), Report and compare the biochemical disease free survival (bDFS), Report and compare the disease free survival (DFS), Report and compare the metastase free survival (MFS), and Report and compare the overall survival (OS)
- standard of care fractionation (SOC)Existing treatment, for comparison
20-25 radiation treatments (range: 1,8 to 2,15 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given in 20-25 working day treatments over 4-5 weeks for a total of 43 Gy to 46 Gy.
Treatment: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS), Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):, Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM), Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE), Report and compare the biochemical disease free survival (bDFS), Report and compare the disease free survival (DFS), Report and compare the metastase free survival (MFS), and Report and compare the overall survival (OS)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pelvic Nodes Ultra-Hypo Fractionated Versus Conventionally Fractionated IMRT With HDR Brachytherapy Boost in Prostate Cancer: A Collaborative Multi-institutional Non-inferiority Phase 3 Trial. (PCS-XI)
- Record updated
- 12 September 2025