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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05786742
Other study ID # HYPO-5
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date December 2033

Study information

Verified date March 2024
Source CHU de Quebec-Universite Laval
Contact Andre-Guy Martin
Phone 14186915264
Email andre-guy.martin.med@ssss.gouv.qc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 205
Est. completion date December 2033
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Radiation:
grade and compare reported side effects between groups
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.

Locations

Country Name City State
Canada CHUdeQuebec Quebec

Sponsors (1)

Lead Sponsor Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

References & Publications (19)

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 c — View Citation

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. Ep — View Citation

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( — View Citation

D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. doi: 10.1001/jama.299.3.289. — View Citation

Gregoire JP, Moisan J, Labrecque M, Cusan L, Diamond P. [Validation of a French adaptation of the international prostatic symptom score]. Prog Urol. 1996 Apr;6(2):240-9. French. — View Citation

Grimm 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, Langl — View Citation

Hill 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. — View Citation

Holm 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. — View Citation

Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. d — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

Morton 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 O — View Citation

Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millennium. Urology. 2001 Dec;58(6):843-8. doi: 10.1016/s0090-4295(01)01441-8. — View Citation

Schmidt 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. — View Citation

Stone 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 — View Citation

Viani 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. — View Citation

Williams 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. — View Citation

Wright 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. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary GU toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at baseline, prior treatment
Primary GU toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 3 months post-therapy
Primary GU toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 6 months post-therapy
Primary GU toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 1 year post-therapy
Primary GU toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 2 years post-therapy
Primary GU toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 3 years post-therapy
Primary GU toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 4 years post-therapy
Primary GU toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 5 years post-therapy
Primary GI toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at baseline, prior treatment
Primary GI toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 3 months post-therapy
Primary GI toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 6 months post-therapy
Primary GI toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 1 year post-therapy
Primary GI toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 2 years post-therapy
Primary GI toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 3 years post-therapy
Primary GI toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 4 years post-therapy
Primary GI toxicity analysis (CTCAE) quantitatively evaluated using CTCAE (v5) and compare between arms at 5 years post-therapy
Primary urinary toxicity analysis (IPSS) median IPSS scores will be reported post-therapy and compare between arms at baseline, prior treatment at baseline, prior treatment
Primary urinary toxicity analysis (IPSS) median IPSS scores will be reported post-therapy and compare between arms at 3 months post-therapy at 3 months
Primary urinary toxicity analysis (IPSS) median IPSS scores will be reported post-therapy and compare between arms at 6 months post-therapy at 6 months
Primary urinary toxicity analysis (IPSS) median IPSS scores will be reported post-therapy and compare between arms at 1 year post-therapy at 1 year
Primary urinary toxicity analysis (IPSS) median IPSS scores will be reported post-therapy and compare between arms at 2 years post-therapy at 2 years
Primary urinary toxicity analysis (IPSS) median IPSS scores will be reported post-therapy and compare between arms at 3 years post-therapy at 3 years
Primary urinary toxicity analysis (IPSS) median IPSS scores will be reported post-therapy and compare between arms at 4 years post-therapy at 4 years
Primary urinary toxicity analysis (IPSS) median IPSS scores will be reported post-therapy and compare between arms at 5 years post-therapy at 5 years
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary sexual function analysis (SHIM) median SHIM scores will be reported at baseline prior treatment baseline, prior treatment
Primary sexual function analysis (SHIM) median SHIM scores will be reported post-therapy and compare between arms at 3 months post-treatment at 3 months
Primary sexual function analysis (SHIM) median SHIM scores will be reported post-therapy and compare between arms at 6 months post-treatment at 6 months
Primary sexual function analysis (SHIM) median SHIM scores will be reported post-therapy and compare between arms at 1 year post-treatment at 1 year
Primary sexual function analysis (SHIM) median SHIM scores will be reported post-therapy and compare between arms at 2 years post-treatment at 2 years
Primary sexual function analysis (SHIM) median SHIM scores will be reported post-therapy and compare between arms at 3 years post-treatment at 3 years
Primary sexual function analysis (SHIM) median SHIM scores will be reported post-therapy and compare between arms at 4 years post-treatment at 4 years
Primary 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 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. at 5 years
Secondary 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. at 10 years
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