Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

NCT05786742 | Recruiting DMC

• 1 other identifier: HYPO-5
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \& 10 years.

Conditions

Prostate Cancer; Radiotherapy Side Effect; Hypofractionation; Brachytherapy; Radiotherapy; Localized Prostate Carcinoma

Keywords

hypo fractionation; brachytherapy; Ultra Hypo fractionation

Outcome Measures

Primary Outcomes (40)

• GU toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at baseline, prior treatment

• GU toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 3 months post-therapy

• GU toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 6 months post-therapy

• GU toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 1 year post-therapy

• GU toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 2 years post-therapy

• GU toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 3 years post-therapy

• GU toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 4 years post-therapy

• GU toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 5 years post-therapy

• GI toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at baseline, prior treatment

• GI toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 3 months post-therapy

• GI toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 6 months post-therapy

• GI toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 1 year post-therapy

• GI toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 2 years post-therapy

• GI toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 3 years post-therapy

• GI toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 4 years post-therapy

• GI toxicity analysis (CTCAE)

  quantitatively evaluated using CTCAE (v5) and compare between arms

  at 5 years post-therapy

• urinary toxicity analysis (IPSS)

  median IPSS scores will be reported post-therapy and compare between arms at baseline, prior treatment

  at baseline, prior treatment

• urinary toxicity analysis (IPSS)

  median IPSS scores will be reported post-therapy and compare between arms at 3 months post-therapy

  at 3 months

• urinary toxicity analysis (IPSS)

  median IPSS scores will be reported post-therapy and compare between arms at 6 months post-therapy

  at 6 months

• urinary toxicity analysis (IPSS)

  median IPSS scores will be reported post-therapy and compare between arms at 1 year post-therapy

  at 1 year

• urinary toxicity analysis (IPSS)

  median IPSS scores will be reported post-therapy and compare between arms at 2 years post-therapy

  at 2 years

• urinary toxicity analysis (IPSS)

  median IPSS scores will be reported post-therapy and compare between arms at 3 years post-therapy

  at 3 years

• urinary toxicity analysis (IPSS)

  median IPSS scores will be reported post-therapy and compare between arms at 4 years post-therapy

  at 4 years

• urinary toxicity analysis (IPSS)

  median IPSS scores will be reported post-therapy and compare between arms at 5 years post-therapy

  at 5 years

• quality of life questionnaires analysis (EPIC26)

  median EPIC26 scores will be reported post-therapy and compare between arms at baseline, prior treatment

  baseline, prior treatment

• quality of life questionnaires analysis (EPIC26)

  median EPIC26 scores will be reported post-therapy and compare between arms at 3 months post-treatment

  at 3 months

• quality of life questionnaires analysis (EPIC26)

  median EPIC26 scores will be reported post-therapy and compare between arms at 6 months post-treatment

  at 6 months

• quality of life questionnaires analysis (EPIC26)

  median EPIC26 scores will be reported post-therapy and compare between arms at 1 year post-treatment

  at 1 year

• quality of life questionnaires analysis (EPIC26)

  median EPIC26 scores will be reported post-therapy and compare between arms at 2 years post-treatment

  at 2 years

• quality of life questionnaires analysis (EPIC26)

  median EPIC26 scores will be reported post-therapy and compare between arms at 3 years post-treatment

  at 3 years

• quality of life questionnaires analysis (EPIC26)

  median EPIC26 scores will be reported post-therapy and compare between arms at 4 years post-treatment

  at 4 years

• quality of life questionnaires analysis (EPIC26)

  median EPIC26 scores will be reported post-therapy and compare between arms at 5 years post-treatment

  at 5 years

• sexual function analysis (SHIM)

  median SHIM scores will be reported at baseline prior treatment

  baseline, prior treatment

• sexual function analysis (SHIM)

  median SHIM scores will be reported post-therapy and compare between arms at 3 months post-treatment

  at 3 months

• sexual function analysis (SHIM)

  median SHIM scores will be reported post-therapy and compare between arms at 6 months post-treatment

  at 6 months

• sexual function analysis (SHIM)

  median SHIM scores will be reported post-therapy and compare between arms at 1 year post-treatment

  at 1 year

• sexual function analysis (SHIM)

  median SHIM scores will be reported post-therapy and compare between arms at 2 years post-treatment

  at 2 years

• sexual function analysis (SHIM)

  median SHIM scores will be reported post-therapy and compare between arms at 3 years post-treatment

  at 3 years

• sexual function analysis (SHIM)

  median SHIM scores will be reported post-therapy and compare between arms at 4 years post-treatment

  at 4 years

• sexual function analysis (SHIM)

  median SHIM scores will be reported post-therapy and compare between arms at 5 years post-treatment

  at 5 years

Secondary Outcomes (2)

• Clinical outcomes

  at 5 years

• Clinical outcomes

  at 10 years

Study Arms (2)

ultra hypo fractionation radiation therapy

EXPERIMENTAL

comparative PRO's of 25 Gy in 5 daily fractions (Ultra hypo fractionation) administered to prostate and 1st centimeter of proximal seminal vesicle, starting mid week and ending mid following week.

Radiation: grade and compare reported side effects between groups

moderate hypo fractionation radiation therapy

ACTIVE COMPARATOR

PRO's of moderate hypo fractionation, 37,5 Gy in 15 or 36 Gy in 12 daily fractions administered 5 days per week.

Radiation: grade and compare reported side effects between groups

Interventions

grade and compare reported side effects between groups RADIATION

Compare experimental ultra hypo fractionation (25 Gy in 5 daily fractions administered starting mid week and ending mid following week) to our standard fractionation (either 37,5 Gy given in 15 daily fractions, or 36 Gy in 12 daily fractions). * Toxicity analysis will be quantitatively evaluated using CTCAE (v5) at 1, 2 and 5 years post-therapy, and has needed at FU visits. Kaplan-Meier statistical analysis will be used to report toxicity evolution through time. * median IPSS scores will be reported at 3, 6, 12 months and yearly (1, 2, 3, 4 et 5) post-therapy. IPSS median time to baseline return will be calculated. * IPSS urinary scores, sexual function (SHIM) and GI toxicity (CTCAE-v5) and quality of life questionnaires ( EPIC-26) will be given at 3, 6 months and yearly thereafter (1, 2, 3, 4 et 5) post-treatment.

Also known as: report and compare IPSS scores, report and compare EPIC26 scores, report and compare SHIM scores, report and compare CTCAE scores, report and compare clinical outcomes

moderate hypo fractionation radiation therapy; ultra hypo fractionation radiation therapy

Eligibility Criteria

• Age: 18 Years - 95 Years
• Gender Eligibility Details: men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven Prostate adenocarcinoma
• Stage T1c, T2 (Annex 2)
• Stage Nx or N0
• Stage Mx or M0
• PSA \< 20ng/ml
• Gleason Score 6 or 7
• Having the ability to sing a written consent

You may not qualify if:

• Age \< 18ans
• Clinical Stage T3 or T4
• Stage N1
• Stage M1
• PSA \> 20
• Gleason Score 8 to 10
• IPSS Score \> 20 alpha-blocking medication.
• Prior pelvic radiotherapy.
• History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)
• Past history of Inflammatory Bowell Disease
• Bilateral hip prosthesis

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHUdeQuebec

Québec, G1R 2J6, Canada

RECRUITING

Related Publications (19)

• Crook JM, Gomez-Iturriaga A, Wallace K, Ma C, Fung S, Alibhai S, Jewett M, Fleshner N. Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial. J Clin Oncol. 2011 Feb 1;29(4):362-8. doi: 10.1200/JCO.2010.31.7305. Epub 2010 Dec 13.

  PMID: 21149658 RESULT

• Bachand F, Martin AG, Beaulieu L, Harel F, Vigneault E. An eight-year experience of HDR brachytherapy boost for localized prostate cancer: biopsy and PSA outcome. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):679-84. doi: 10.1016/j.ijrobp.2008.05.003. Epub 2008 Oct 27.

  PMID: 18963537 RESULT

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  PMID: 22239226 RESULT

• Morris WJ, Keyes M, Palma D, Spadinger I, McKenzie MR, Agranovich A, Pickles T, Liu M, Kwan W, Wu J, Berthelet E, Pai H. Population-based study of biochemical and survival outcomes after permanent 125I brachytherapy for low- and intermediate-risk prostate cancer. Urology. 2009 Apr;73(4):860-5; discussion 865-7. doi: 10.1016/j.urology.2008.07.064. Epub 2009 Jan 24.

  PMID: 19168203 RESULT

• Morris WJ, Keyes M, Spadinger I, Kwan W, Liu M, McKenzie M, Pai H, Pickles T, Tyldesley S. Population-based 10-year oncologic outcomes after low-dose-rate brachytherapy for low-risk and intermediate-risk prostate cancer. Cancer. 2013 Apr 15;119(8):1537-46. doi: 10.1002/cncr.27911. Epub 2012 Dec 26.

  PMID: 23280183 RESULT

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MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

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

Study Officials

• Andre-Guy Martin

  CHU de Québec

  STUDY CHAIR

Central Study Contacts

Andre-Guy Martin

CONTACT

14186915264; andre-guy.martin.med@ssss.gouv.qc.ca

Josee Allard

CONTACT

14186915264; josee.allard@chudequebec.ca

Study Design

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

Model Details: Prospective comparative cohort study with non inferiority analysis UH-IMRT combined to 15 Gy HDR Brachytherapy will considerably reduce the treatment fraction delivered while maintaining b-DFS and Side-effects at comparable levels to our actual reported prostate cancer patient population, without lymph nodes involvement (risk being less than 15%). We believe that this therapeutic regime will show to be non-inferior to our actual standard therapeutic regime

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: March 28, 2023
• Study Start: April 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2033
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)