Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer. (PCS-XI)

September 7, 2025 updated by: André-Guy Martin, CHU de Quebec-Universite Laval

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)

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer is the most common non-skin cancer in North American men. In 2020, an estimated 23 300 Canadian men will be diagnosed with prostate cancer of which, 4200 will die. Fortunately, with an early screening, most will have a localized disease at diagnosis. Despite this, high risk disease affects a growing portion of the population and this according to age (29.3%, 39.1%, 60.4%, et 90.6% respectively at 55-59, 65-69, 75-79, & 85-89 years of age). Gleason score 8 to 10 tumors follow the same pattern (16.5%, 23.4%, 37.2%, and 59.9% at respective ages). Those patients are at risk for harboring lymph nodes metastasis.

Multiple therapeutic options, with similar biochemical disease-free survival (bDFS) are available: surgery +/- salvage radiotherapy +/- androgen deprivation therapy (ADT) or radiotherapy (RT) +/- HDR-BT +/- ADT. For men with high-risk disease, the combined approach of RT + HDR-BT + ADT might even offer higher cancer specific survival (CSS) rates when compared to surgery.

HDR-BT allows for the delivery of a very high (ablative) dose of radiation while giving a lower dose to the nearby organs at risk (OARs). Recently published literature showed that pelvic RT plus HDR-BT significantly increased bDFS (84 vs 77%).

Pelvic RT is generally given on a daily basis (5 days/week) over a period of 4-5 weeks, with 1,8-2,15Gy per fraction. This requires a substantial time investment from patients undergoing treatment. Many studies have shown that prostate cancer offers a radiation cell kill ratio (α/β) of 0.9-1.5 Gy. Furthermore, the most commonly used α/β value for prostate cancer is 1,5 Gy (range 0,8 - 2,2). This low α/β ratio offers a more efficient cell kill with hypo-fractionated doses, offering a better tumor control with a lower cumulative dose, given in a shorter time span. Recently, a multicentric randomized phase III study has shown similar late toxicity and oncologic control outcomes between UHF (>/= 5 Gy/fraction) and conventionally fractionated RT. However, until now, no phase III study has compared combined UHF pelvic RT to standard fractionation combined with an HDR-BT in this population.

The proposed experimental fractionation scheme for whole pelvic RT in this study will be 5Gy administered every other day over 2 weeks (UHF). It will be compared to standard pelvic RT (1.8-2.15Gy/working day) given over 4 to 5 weeks. Both will be combined with a single 15 Gy fraction of HDR-BT and ADT (goserelin). The UHF treatment modality significantly reduces the overall treatment time, freeing machine-time and allowing more patients to be treated. Given its low α/β ratio, prostate cancer is readily amenable to UHF fractionation. The bio-equivalent dose calculations were done based on published litterature. Neo-adjuvant and adjuvant ADT (goserelin) will be administered for a duration according to NCCN guidelines.

In these COVID-19 pandemic times, a reduction in the number of patients' visits to the clinic is highly desirable in order to limit the risk of virus transmission. UHF would also lower the socio-economic burden incurred by the patients and their families. It also increases the therapeutic efficiency reducing costs for both, patients and health services. The proposed study aims to demonstrate the non-inferiority of UHF treatment compared to standard of care. If this hypothesis is confirmed, all future patients could benefit from it.

In order to improve the quality of life of men diagnosed with prostate cancer this study aim to demonstrate that combined UHF pelvic RT plus HDR-BT (+ ADT according to NCCN guidelines) is safe and non-inferior to standard fractionation regimens in regard to toxicities and tumor control for prostate cancer patients with risk of nodal involvement. Therefore, 500 men will be recruited, in order to confirm the hypothesis.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1R 2J6
        • CHU de Québec - Université Laval
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer Sindi Ahluwalia centre for the Southern Interior
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2N1
        • Carlo Fidani Peel Regional Cancer Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa Cancer centre
    • Quebec
      • Gatineau, Quebec, Canada, J8P 7H2
        • CISSS de l'Outaouais, Hôpital de Gatineau
      • Laval, Quebec, Canada, H7M 3L9
        • CISSS de Laval, Hôpital de la Cité-de-la-Santé
      • Longueuil, Quebec, Canada, J4V 2H1
        • CISSS de la Montérégie-Centre, Hôpital Charles-Le Moyne
      • Montreal, Quebec, Canada, H3T 1E2
        • CIUSSS du Centre-Ouest-de-l'Île-de-Montréal, Jewish General Hospital
      • Montreal, Quebec, Canada, H4A 3J1
        • Cedars Cancer Centre, McGill University Health Centre (MUHC)
      • Montreal East, Quebec, Canada, H1T 2M4
        • CIUSSS de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont
      • Sherbrooke, Quebec, Canada
        • CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultra hypo fractionation radiation therapy (UHF)
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.
Radiation: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)
Assess early and late genito-urinary (GU) toxicities induced assessed via the International Prostate Symptom Score (I-PSS) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):
Assess early and late genito-urinary (GU) and gastro-intestinal (GI) toxicities induced and quality of life assessed via expanded prostate cancer index composite (EPIC-26) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)
Assess early and late sexual health in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)
Assess early and late toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Radiation: Report and compare the biochemical disease free survival (bDFS)
Assess the 5 and 10 years biochemical disease-free survival (bDFS) in the UHF group and compare them for non-inferiority to those of the control group.
Radiation: Report and compare the disease free survival (DFS)
Assess the 5 and 10 years disease-free survival (DFS) in the UHF group and compare them for non-inferiority to those of the control group.
Radiation: Report and compare the metastase free survival (MFS)
Assess the 5 and 10 years metastasis-free survival (MFS) in the UHF group and compare them for non-inferiority to those of the control group.
Radiation: Report and compare the overall survival (OS)
Assess the 5 and 10 years overall survival (OS) in the UHF group and compare them for non-inferiority to those of the control group.
Active Comparator: standard of care fractionation (SOC)
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.
Radiation: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)
Assess early and late genito-urinary (GU) toxicities induced assessed via the International Prostate Symptom Score (I-PSS) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):
Assess early and late genito-urinary (GU) and gastro-intestinal (GI) toxicities induced and quality of life assessed via expanded prostate cancer index composite (EPIC-26) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)
Assess early and late sexual health in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)
Assess early and late toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Radiation: Report and compare the biochemical disease free survival (bDFS)
Assess the 5 and 10 years biochemical disease-free survival (bDFS) in the UHF group and compare them for non-inferiority to those of the control group.
Radiation: Report and compare the disease free survival (DFS)
Assess the 5 and 10 years disease-free survival (DFS) in the UHF group and compare them for non-inferiority to those of the control group.
Radiation: Report and compare the metastase free survival (MFS)
Assess the 5 and 10 years metastasis-free survival (MFS) in the UHF group and compare them for non-inferiority to those of the control group.
Radiation: Report and compare the overall survival (OS)
Assess the 5 and 10 years overall survival (OS) in the UHF group and compare them for non-inferiority to those of the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority analysis of early change in genito-urinary (GU) toxicities induced.
Time Frame: Every 3 months for 1 year.
Assess early genito-urinary (GU) toxicities induced opposed to baseline assessed via the International Prostate Symptom Score (I-PSS) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Every 3 months for 1 year.
Non-inferiority analysis of early change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.
Time Frame: Every 3 months for 1 year.
Assess early health-related quality of life opposed to baseline assessed via the Expanded Prostate Cancer Index Composite (EPIC-26) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year.
Every 3 months for 1 year.
Non-inferiority analysis of late change in genito-urinary (GU) toxicities induced.
Time Frame: Every 6 months up to 36 months, then annually up to 10 years.
Assess late genito-urinary (GU) toxicities induced opposed to baseline evaluated by the International Prostate Symptom Score (I-PSS) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).
Every 6 months up to 36 months, then annually up to 10 years.
Non-inferiority analysis of late change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.
Time Frame: Every 6 months up to 36 months, then annually up to 10 years.
Assess late health-related quality of life opposed to baseline assessed via the Expanded Prostate Cancer Index Composite (EPIC-26) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 6 months up to 36 months, then annually.
Every 6 months up to 36 months, then annually up to 10 years.
Non-inferiority analysis of early change in sexual health.
Time Frame: Every 3 months for 1 year.
Assess early quality of life opposed to baseline assessed via the Sexual Health Inventory for Men (SHIM) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year.
Every 3 months for 1 year.
Non-inferiority analysis of late change in sexual health.
Time Frame: Every 6 months up to 36 months, then annually up to 10 years.
Assess early sexual health status opposed to baseline assessed via the Sexual Health Inventory for Men (SHIM) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 6 months up to 36 months, then annually.
Every 6 months up to 36 months, then annually up to 10 years.
Non-inferiority analysis of early change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame: Every 3 months for 1 year.
Assess early reported toxicities opposed to baseline assessed via the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year, every 6 months up to 36 months, then annually.
Every 3 months for 1 year.
Non-inferiority analysis of late change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame: Every 6 months up to 36 months, then annually up to 10 years.
Assess early reported toxicities opposed to baseline assessed via the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year, every 6 months up to 36 months, then annually.
Every 6 months up to 36 months, then annually up to 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority analysis of 5 years biochemical Disease Free Survival.
Time Frame: 5 years (median)
Assess the 5 years the biochemical disease-free survival (bDFS) in the UH group and compare them for non-inferiority to those of the control group.
5 years (median)
Non-inferiority analysis of 5 years Disease Free Survival.
Time Frame: 5 years (median)
Assess the 5 years the disease-free survival (DFS) in the UH group and compare them for non-inferiority to those of the control group.
5 years (median)
Non-inferiority analysis of 5 years Metastasis Free Survival.
Time Frame: 5 years (median)
Assess the 5 years the Metastasis Free Survival (MFS) in the UH group and compare them for non-inferiority to those of the control group.
5 years (median)
Non-inferiority analysis of 5 years Overall Survival.
Time Frame: 5 years (median)
Assess the 5 years the Overall Survival (OS) in the UH group and compare them for non-inferiority to those of the control group.
5 years (median)
Non-inferiority analysis of 10 years biochemical Disease Free Survival.
Time Frame: 10 years (median)
Assess the 10 years the biochemical disease-free survival (bDFS) in the UH group and compare them for non-inferiority to those of the control group.
10 years (median)
Non-inferiority analysis of 10 years Disease Free Survival.
Time Frame: 10 years (median)
Assess the 10 years the disease-free survival (DFS) in the UH group and compare them for non-inferiority to those of the control group.
10 years (median)
Non-inferiority analysis of 10 years Metastasis Free Survival.
Time Frame: 10 years (median)
Assess the 10 years the Metastasis Free Survival (MFS) in the UH group and compare them for non-inferiority to those of the control group.
10 years (median)
Non-inferiority analysis of 10 years Overall Survival.
Time Frame: 10 years (median)
Assess the 10 years the Overall Survival (OS) in the UH group and compare them for non-inferiority to those of the control group.
10 years (median)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seric Testosterone change.
Time Frame: From baseline (randomisation), then every 3 months for 3 years, every 6 months for 2 years, and annually up to 10 years.
Testosterone blood level, every 3 months for 3 years, every 6 months for 2 years, then annually.
From baseline (randomisation), then every 3 months for 3 years, every 6 months for 2 years, and annually up to 10 years.
Complete blood count.
Time Frame: Baseline prior treatment.
Complete blood count.
Baseline prior treatment.
Alkaline Phosphatase.
Time Frame: Baseline prior treatment.
Alkaline Phosphatase blood level.
Baseline prior treatment.
Blood urea nitrogen (BUN)
Time Frame: Baseline prior treatment.
Serum creatinine to evaluate renal function.
Baseline prior treatment.
Serum creatinine
Time Frame: Baseline prior treatment.
Serum creatinine to evaluate renal function.
Baseline prior treatment.
Concomitant added medications list.
Time Frame: Every 3 months for 3 years, every 6 months for 2 years, then annually up to 10 years.
List of added medications (name and dosage) needed to alleviate symptoms of potential side effects of therapy and evolution of disease.
Every 3 months for 3 years, every 6 months for 2 years, then annually up to 10 years.
Treatment related loss of income evaluation in dollars estimated through the economic questionnaire.
Time Frame: Baseline and Month 3.
Evaluate loss of outcomes (dollars) due to treatment
Baseline and Month 3.
Total body bone scan in order to evaluate if bony metastasis are present or not.
Time Frame: Baseline prior treatment.
Tumor extension description if presence of bony metastasis or not (for staging purposes)
Baseline prior treatment.
Abdomino-Pelvis (thorax not compulsory) CT Scan in order to evaluate if metastasis are present or not.
Time Frame: Baseline prior treatment.
Abdominal + Pelvis (thorax not compulsory) for tumor extension description =determination if presence of distant metastasis or not (for staging purposes)
Baseline prior treatment.
Osteodensitometry.
Time Frame: Baseline within the first year.
Bone density evaluation to prevent osteoporosis
Baseline within the first year.
Prostate MRI scan in order to evaluate if extra capsular tumor extension are present or not.
Time Frame: Baseline prior treatment.
Recommended but not compulsory - Prostate MRI (tumor description of dominant involved lesion) for determination if presence extension extra capsulary or not.
Baseline prior treatment.
Total body PET scan in order to evaluate if metastasis are present or not.
Time Frame: Baseline prior treatment.
Optional (tumor extension description if presence of metastasis or not)
Baseline prior treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

TerSera Therapeutics LLC

Investigators

  • Principal Investigator: Andre-Guy Martin, MD MSc FRCPC, Andre-Guy Martin MD Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

February 26, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 7, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-20-2023-6396: PCS XI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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