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Comparing two types of radiation therapy for prostate cancer treatment

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)

Not applicable Interventional CHU de Quebec-Universite Laval · NCT05820633

This study is testing if a new type of radiation therapy for prostate cancer can be just as effective as the standard treatment but with a shorter treatment time.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years to 95 Years
SexMale
SponsorCHU de Quebec-Universite Laval Academic / other
Drugs / interventionsradiation
Locations11 sites (Kelowna, British Columbia and 10 other locations)
Trial IDNCT05820633 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized Phase III study that compares pelvic ultra-hypo fractionated radiotherapy (UHF) with conventional or moderate hypo-fractionation in patients with prostate cancer. Both treatment approaches are combined with high-dose rate brachytherapy and androgen deprivation therapy according to established guidelines. The primary objective is to assess the non-inferiority of UHF in terms of treatment acceptability, tolerance, and adverse events, while secondary objectives include evaluating biochemical control and survival outcomes. The study aims to determine if the UHF technique can provide similar efficacy with potentially reduced treatment time.

Who should consider this trial

Good fit: Ideal candidates for this study are men diagnosed with high-risk prostate cancer who require pelvic radiotherapy and have a risk of lymph node involvement.

Not a fit: Patients with metastatic prostate cancer or those who have previously undergone pelvic radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more efficient radiation therapy option for prostate cancer patients, potentially reducing treatment time without compromising effectiveness.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating that ultra-hypo fractionation may be a viable treatment option.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Clinical stage M1.
* IPSS Score \> 20 with alpha-blocking medication.
* Prior pelvic radiotherapy,
* History of active collagenosis (Lupus, Scleroderma, Dermatomyositis).
* Past history of Inflammatory Bowell Disease.
* Bilateral hip prosthesis.

Where this trial is running

Kelowna, British Columbia and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerNodeProstateRadiotherapy Side Effectultra hypo fractionationbrachytherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.