Prostate CancerHYPO-5NCT05786742
Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
A study testing grade and compare reported side effects between groups in people with Prostate Cancer and Radiotherapy Side Effect, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Radiotherapy Side Effect, Hypofractionation
- What is being tested?
- grade and compare reported side effects between groups
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Dec 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18ans
- Clinical Stage T3 or T4
- Stage N1
- Stage M1
- PSA > 20
- Gleason Score 8 to 10
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHUdeQuebec
Québec, G1R 2J6
Andre-Guy Martin, MD,MSc,FRCPC, 1-418-691-5264, Andre-Guy.Martin.med@ssss.gouv.qc.ca
Josée Allard, MSc, 1-418-691-5264 ext. 16730, Josee.Allard@chuq.qc.ca
About this study
Official title: ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.
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.
Read the detailed description
Phase 1 : consists in a feasibility study (First 28 patients).
Phase 2 : monocentric prospective comparative cohort study.
Recruitment :
- "Centre intégré de cancérologie du CHU de Québec-Université Laval."
- Recruitment period: December 2015 to June 2023
Brachytherapy :
- Implantation under general or spinal anesthesia
- Foley catheter insertion in bladder.
- TRUS prostate localisation.
- Prostate volume measurement.
- Gold fiducial markers (3) insertion.
- Prostate brachytherapy catheters (14 à 21) insertion.
- Cystoscopy for bladder and urethra integrity control.
- Re-insertion of foley catheter after cystoscopy.
Planning imaging: TRUS or CT scan (has needed).
Structures delineation by radiation oncologist (brachytherapist).
- Prostate
- Seminale vesicles
- Rectum
- Colon sigmoïde
- Bladder
- Urethra
- Penile bulb
Dosimetric optimisation
- Oncentra Prostate v. 4.2.2 d'Elekta brachytherapy (Veenendaal, The Netherlands)
- Oncentra Brachy version 4.6 (if under CT scan).
Treatment (brachytherapy dose delivery).
- 15 Gy in one fraction
- Direct interstitial dose monitoring (20 patients or more). Fiber-optic dosimeter inserted in prostate brachytherpy catheter for live dose delivery mesurements.
Foley ablation under full bladder, same day or day after therapy.
Radiotherapy:
- Via IMRT, VMAT or SBRT technics.
- Dose : 25 Gy in 5 fractions administered over a 7 days period. 2 to 3 fractions separated by 2 days, weekend break.
- PTV includes prostate and the first centimeter of seminal vesicle.
Simulation
- one week post brachytherapy
- standard has described in the department procedure manual.
- maximal CT scan slice thickness : 2-3mm.
- uretro-graphy done to identify urogenital sphincter.
Multiparametric MRI
- If no counter-indication and available,
- a T2 tridimensional sequence for prostate delineation
- slice thickness : 1 mm.
- a diffusion weighted sequence will be done.
- a DTI with tractography can be done optionally.
- contrast media (gadolinium) is optional.
Physique
- Linac energy (between 6 MV to 18 MV).
- ARC therapy technique will be used
- planification softwares: Éclipse, Pinnacle or Raystation.
- Portal (kV-kV) imagery will be used for marker match.
- CBCT will be done at each fraction delivered.
Clinical and dosimetric data will be collected prior treatment.
Primary objectives :
- 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.
Secondary objectives : Biochemical disease-free survival has per Phoenix definition (by American Society of Radiation Oncology - ASTRO) recommendation will be reported using Kaplan-Meier analysis.
- Conditions
- Prostate Cancer, Radiotherapy Side Effect, Hypofractionation, Brachytherapy, Radiotherapy, Localized Prostate Carcinoma
- Being tested
- grade and compare reported side effects between groups
- Keywords
- hypo fractionation, brachytherapy, Ultra Hypo fractionation
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grade and compare reported side effects between groupsRadiation
Also called report and compare IPSS scores, report and compare EPIC26 scores, report and compare SHIM scores, report and compare CTCAE scores
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: grade and compare reported side effects between groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at baseline, prior treatment
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 3 months post-therapy
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 6 months post-therapy
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 1 year post-therapy
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 2 years post-therapy
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 3 years post-therapy
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 4 years post-therapy
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 5 years post-therapy
GI toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at baseline, prior treatment
GI toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 3 months post-therapy
GI toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 6 months post-therapy
GI toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 1 year post-therapy
GI toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 2 years post-therapy
GI toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 3 years post-therapy
GI toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: at 4 years post-therapy
GI toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Measured: 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
Measured: 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
Measured: at 3 months
urinary toxicity analysis (IPSS)
median IPSS scores will be reported post-therapy and compare between arms at 6 months post-therapy
Measured: at 6 months
urinary toxicity analysis (IPSS)
median IPSS scores will be reported post-therapy and compare between arms at 1 year post-therapy
Measured: at 1 year
urinary toxicity analysis (IPSS)
median IPSS scores will be reported post-therapy and compare between arms at 2 years post-therapy
Measured: at 2 years
urinary toxicity analysis (IPSS)
median IPSS scores will be reported post-therapy and compare between arms at 3 years post-therapy
Measured: at 3 years
urinary toxicity analysis (IPSS)
median IPSS scores will be reported post-therapy and compare between arms at 4 years post-therapy
Measured: at 4 years
urinary toxicity analysis (IPSS)
median IPSS scores will be reported post-therapy and compare between arms at 5 years post-therapy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 5 years
sexual function analysis (SHIM)
median SHIM scores will be reported at baseline prior treatment
Measured: baseline, prior treatment
sexual function analysis (SHIM)
median SHIM scores will be reported post-therapy and compare between arms at 3 months post-treatment
Measured: at 3 months
sexual function analysis (SHIM)
median SHIM scores will be reported post-therapy and compare between arms at 6 months post-treatment
Measured: at 6 months
sexual function analysis (SHIM)
median SHIM scores will be reported post-therapy and compare between arms at 1 year post-treatment
Measured: at 1 year
sexual function analysis (SHIM)
median SHIM scores will be reported post-therapy and compare between arms at 2 years post-treatment
Measured: at 2 years
sexual function analysis (SHIM)
median SHIM scores will be reported post-therapy and compare between arms at 3 years post-treatment
Measured: at 3 years
sexual function analysis (SHIM)
median SHIM scores will be reported post-therapy and compare between arms at 4 years post-treatment
Measured: at 4 years
sexual function analysis (SHIM)
median SHIM scores will be reported post-therapy and compare between arms at 5 years post-treatment
Measured: at 5 years
Secondary outcomes (2)
Clinical outcomes
Biochemical disease-free survival has per Phoenix definition (by American Society of Radiation Oncology - ASTRO) will be reported using Kaplan-Meier analysis, as well for disease free survival, metastasis free survival and overall survival.
Measured: at 5 years
Clinical outcomes
Biochemical disease-free survival has per Phoenix definition (by American Society of Radiation Oncology - ASTRO) will be reported using Kaplan-Meier analysis, as well for disease free survival, metastasis free survival and overall survival.
Measured: at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study startApr 2014
- Primary completionJun 2026 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André-Guy Martin, CHU de Quebec-Universite Laval
- Investigators
- Andre-Guy Martin, Study chair, CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786742
- Sponsor's protocol ID
- HYPO-5
- Acronym
- HYPO-5
- Status last verified
- Sep 2025
- First submitted
- 23 Dec 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21149658Bachand 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.
PubMed 18963537Grimm P, Billiet I, Bostwick D, Dicker AP, Frank S, Immerzeel J, Keyes M, Kupelian P, Lee WR, Machtens S, Mayadev J, Moran BJ, Merrick G, Millar J, Roach M, Stock R, Shinohara K, Scholz M, Weber E, Zietman A, Zelefsky M, Wong J, Wentworth S, Vera R, Langley S. Comparative analysis of prostate-specific antigen free survival outcomes for patients with low, intermediate and high risk prostate cancer treatment by radical therapy. Results from the Prostate Cancer Results Study Group. BJU Int. 2012 Feb;109 Suppl 1:22-9. doi: 10.1111/j.1464-410X.2011.10827.x.
PubMed 22239226Morris 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.
PubMed 19168203Morris 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.
PubMed 23280183Morton G, Loblaw A, Cheung P, Szumacher E, Chahal M, Danjoux C, Chung HT, Deabreu A, Mamedov A, Zhang L, Sankreacha R, Vigneault E, Springer C. Is single fraction 15 Gy the preferred high dose-rate brachytherapy boost dose for prostate cancer? Radiother Oncol. 2011 Sep;100(3):463-7. doi: 10.1016/j.radonc.2011.08.022. Epub 2011 Sep 14.
PubMed 21924511Wright JL, Izard JP, Lin DW. Surgical management of prostate cancer. Hematol Oncol Clin North Am. 2013 Dec;27(6):1111-35, vii. doi: 10.1016/j.hoc.2013.08.010.
PubMed 24188255Stone NN, Stock RG, Cesaretti JA, Unger P. Local control following permanent prostate brachytherapy: effect of high biologically effective dose on biopsy results and oncologic outcomes. Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):355-60. doi: 10.1016/j.ijrobp.2009.01.078. Epub 2009 Jul 23.
PubMed 19632069Viani GA, Stefano EJ, Afonso SL. Higher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized, controlled trials. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1405-18. doi: 10.1016/j.ijrobp.2008.10.091.
PubMed 19616743Holm HH, Gammelgaard J. Ultrasonically guided precise needle placement in the prostate and the seminal vesicles. J Urol. 1981 Mar;125(3):385-7. doi: 10.1016/s0022-5347(17)55044-2. No abstract available.
PubMed 7206090Hill RP, Rodemann HP, Hendry JH, Roberts SA, Anscher MS. Normal tissue radiobiology: from the laboratory to the clinic. Int J Radiat Oncol Biol Phys. 2001 Feb 1;49(2):353-65. doi: 10.1016/s0360-3016(00)01484-x.
PubMed 11173128Williams MV, Denekamp J, Fowler JF. A review of alpha/beta ratios for experimental tumors: implications for clinical studies of altered fractionation. Int J Radiat Oncol Biol Phys. 1985 Jan;11(1):87-96. doi: 10.1016/0360-3016(85)90366-9.
PubMed 3881377McCammon 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.
PubMed 19362783Schmidt MA, Payne GS. Radiotherapy planning using MRI. Phys Med Biol. 2015 Nov 21;60(22):R323-61. doi: 10.1088/0031-9155/60/22/R323. Epub 2015 Oct 28.
PubMed 26509844Arcangeli 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.
PubMed 20047800