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

NCT05820633 | Suspended DMC

• 1 other identifier: MP-20-2023-6396: PCS XI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Prostate Cancer; Node; Prostate; Radiotherapy Side Effect

Keywords

ultra hypo fractionation; brachytherapy

Outcome Measures

Primary Outcomes (8)

• Non-inferiority analysis of early change in genito-urinary (GU) toxicities induced.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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 Outcomes (8)

• Non-inferiority analysis of 5 years biochemical Disease Free Survival.

  5 years (median)

• Non-inferiority analysis of 5 years Disease Free Survival.

  5 years (median)

• Non-inferiority analysis of 5 years Metastasis Free Survival.

  5 years (median)

• Non-inferiority analysis of 5 years Overall Survival.

  5 years (median)

• Non-inferiority analysis of 10 years biochemical Disease Free Survival.

  10 years (median)

Other Outcomes (12)

• Seric Testosterone change.

  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.

  Baseline prior treatment.

• Alkaline Phosphatase.

  Baseline prior treatment.

Study Arms (2)

ultra hypo fractionation radiation therapy (UHF)

EXPERIMENTAL

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); Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):; Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM); Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE); Radiation: Report and compare the biochemical disease free survival (bDFS); Radiation: Report and compare the disease free survival (DFS); Radiation: Report and compare the metastase free survival (MFS); Radiation: Report and compare the overall survival (OS)

standard of care fractionation (SOC)

ACTIVE COMPARATOR

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); Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):; Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM); Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE); Radiation: Report and compare the biochemical disease free survival (bDFS); Radiation: Report and compare the disease free survival (DFS); Radiation: Report and compare the metastase free survival (MFS); Radiation: Report and compare the overall survival (OS)

Interventions

Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS) RADIATION

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).

standard of care fractionation (SOC); ultra hypo fractionation radiation therapy (UHF)

Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26): RADIATION

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).

standard of care fractionation (SOC); ultra hypo fractionation radiation therapy (UHF)

Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM) RADIATION

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).

standard of care fractionation (SOC); ultra hypo fractionation radiation therapy (UHF)

Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE) RADIATION

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).

standard of care fractionation (SOC); ultra hypo fractionation radiation therapy (UHF)

Report and compare the biochemical disease free survival (bDFS) RADIATION

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.

standard of care fractionation (SOC); ultra hypo fractionation radiation therapy (UHF)

Report and compare the disease free survival (DFS) RADIATION

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.

standard of care fractionation (SOC); ultra hypo fractionation radiation therapy (UHF)

Report and compare the metastase free survival (MFS) RADIATION

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.

standard of care fractionation (SOC); ultra hypo fractionation radiation therapy (UHF)

Report and compare the overall survival (OS) RADIATION

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.

standard of care fractionation (SOC); ultra hypo fractionation radiation therapy (UHF)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• TerSera Therapeutics LLC: collaborator

Study Sites (11)

BC Cancer Sindi Ahluwalia centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Carlo Fidani Peel Regional Cancer Centre

Mississauga, Ontario, L5M 2N1, Canada

Location

Lakeridge Health Oshawa Cancer centre

Oshawa, Ontario, L1G 2B9, Canada

Location

CISSS de l'Outaouais, Hôpital de Gatineau

Gatineau, Quebec, J8P 7H2, Canada

Location

CISSS de Laval, Hôpital de la Cité-de-la-Santé

Laval, Quebec, H7M 3L9, Canada

Location

CISSS de la Montérégie-Centre, Hôpital Charles-Le Moyne

Longueuil, Quebec, J4V 2H1, Canada

Location

CIUSSS du Centre-Ouest-de-l'Île-de-Montréal, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Cedars Cancer Centre, McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada

Location

CIUSSS de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont

Montreal East, Quebec, H1T 2M4, Canada

Location

CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

Location

CHU de Québec - Université Laval

Québec, G1R 2J6, Canada

Location

Related Publications (15)

• Huynh-Le MP, Myklebust TA, Feng CH, Karunamuni R, Johannesen TB, Dale AM, Andreassen OA, Seibert TM. Age dependence of modern clinical risk groups for localized prostate cancer-A population-based study. Cancer. 2020 Apr 15;126(8):1691-1699. doi: 10.1002/cncr.32702. Epub 2020 Jan 3.

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• Greenberger BA, Zaorsky NG, Den RB. Comparison of Radical Prostatectomy Versus Radiation and Androgen Deprivation Therapy Strategies as Primary Treatment for High-risk Localized Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol Focus. 2020 Mar 15;6(2):404-418. doi: 10.1016/j.euf.2019.11.007. Epub 2019 Dec 5.

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• Yin M, Zhao J, Monk P, Martin D, Folefac E, Joshi M, Jin N, Mortazavi A, Verschraegen C, Clinton S. Comparative effectiveness of surgery versus external beam radiation with/without brachytherapy in high-risk localized prostate cancer. Cancer Med. 2020 Jan;9(1):27-34. doi: 10.1002/cam4.2605. Epub 2019 Nov 7.

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• Tharmalingam H, Tsang Y, Choudhury A, Alonzi R, Wylie J, Ahmed I, Henry A, Heath C, Hoskin PJ. External Beam Radiation Therapy (EBRT) and High-Dose-Rate (HDR) Brachytherapy for Intermediate and High-Risk Prostate Cancer: The Impact of EBRT Volume. Int J Radiat Oncol Biol Phys. 2020 Mar 1;106(3):525-533. doi: 10.1016/j.ijrobp.2019.09.044. Epub 2019 Oct 11.

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• McCammon R, Rusthoven KE, Kavanagh B, Newell S, Newman F, Raben D. Toxicity assessment of pelvic intensity-modulated radiotherapy with hypofractionated simultaneous integrated boost to prostate for intermediate- and high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):413-20. doi: 10.1016/j.ijrobp.2008.10.050. Epub 2009 Apr 11.

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• Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellen E, Franzen L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019 Aug 3;394(10196):385-395. doi: 10.1016/S0140-6736(19)31131-6. Epub 2019 Jun 18.

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• Arcangeli G, Saracino B, Gomellini S, Petrongari MG, Arcangeli S, Sentinelli S, Marzi S, Landoni V, Fowler J, Strigari L. A prospective phase III randomized trial of hypofractionation versus conventional fractionation in patients with high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):11-8. doi: 10.1016/j.ijrobp.2009.07.1691. Epub 2010 Jan 4.

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Related Links

• Canadian Cancer Society, statistics on prostate cancer

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Interventions

Menogaril

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nogalamycin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Andre-Guy Martin, MD MSc FRCPC

  Andre-Guy Martin MD Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D., M.Sc., F.R.C.P.C.

Model Details: randomized phase 3 study

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: April 19, 2023
• Study Start: September 1, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2035
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)