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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.
Phase 1 : consists in a feasibility study (First 28 patients).
Phase 2 : monocentric prospective comparative cohort study.
Recruitment :
Brachytherapy :
Planning imaging: TRUS or CT scan (has needed).
Structures delineation by radiation oncologist (brachytherapist).
Dosimetric optimisation
Treatment (brachytherapy dose delivery).
Foley ablation under full bladder, same day or day after therapy.
Radiotherapy:
Simulation
Multiparametric MRI
Physique
Clinical and dosimetric data will be collected prior treatment.
Primary objectives :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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).
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical outcomes |
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Inclusion Criteria:
Exclusion Criteria:
men
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andre-Guy Martin | Contact | 14186915264 | andre-guy.martin.med@ssss.gouv.qc.ca | |
| Josee Allard | Contact | 14186915264 | josee.allard@chudequebec.ca |
| Name | Affiliation | Role |
|---|---|---|
| Andre-Guy Martin | CHU de Québec | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUdeQuebec | Recruiting | Québec | G1R 2J6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21149658 | Result | 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. | |
| 18963537 | Result |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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
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|
|
| 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 |
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 |
| 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. |
| 22239226 | Result | 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, 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. |
| 19168203 | 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. |
| 23280183 | 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. |
| 21924511 | Result | 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 Oncol. 2011 Sep;100(3):463-7. doi: 10.1016/j.radonc.2011.08.022. Epub 2011 Sep 14. |
| 24188255 | Result | 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. |
| 19632069 | Result | 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.ijrobp.2009.01.078. Epub 2009 Jul 23. |
| 19616743 | Result | 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. |
| 7206090 | Result | 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. |
| 11173128 | Result | 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. |
| 3881377 | Result | 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. |
| 19362783 | Result | 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. |
| 26509844 | Result | 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. |
| 20047800 | Result | 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. |
| 18212313 | Result | 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. |
| 21751904 | Result | 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. doi: 10.1056/NEJMoa1012348. |
| 11744442 | Result | 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. |
| 8777417 | Result | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |