Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
About this 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.
- Condition
- Prostate Cancer, Radiotherapy Side Effect, Hypofractionation, Brachytherapy, Radiotherapy, Localized Prostate Carcinoma
- Tested
- grade and compare reported side effects between groups
- Sponsor
- CHU de Quebec-Universite Laval
Who can join
- Age
- 18 to 95 years
- Sex
- Male only
- Healthy volunteers
- Accepted
Inclusion 11
- Minimum age: 18 years
- Maximum age: 95 years
- Eligible sex: Male
- Study condition: Prostate Cancer, Radiotherapy Side Effect, Hypofractionation, Brachytherapy, Radiotherapy, Localized Prostate Carcinoma
- 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 11
- 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
Where
1 site, 1 recruiting
CHUdeQuebec
Québec, Canada
Contact
-
Andre-Guy Martin
14186915264 andre-guy.martin.med@ssss.gouv.qc.ca
-
Josee Allard
14186915264 josee.allard@chudequebec.ca
Potential match only. Final eligibility is determined by the study team.