ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
CHUdeQuebec
RECRUITING
Québec
Contact Information
Primary
Andre-Guy Martin
andre-guy.martin.med@ssss.gouv.qc.ca
14186915264
Backup
Josee Allard
josee.allard@chudequebec.ca
14186915264
Time Frame
Start Date: 2014-04
Estimated Completion Date: 2033-12
Participants
Target number of participants: 205
Treatments
Experimental: ultra hypo fractionation radiation therapy
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.
Active_comparator: moderate hypo fractionation radiation therapy
PRO's of moderate hypo fractionation, 37,5 Gy in 15 or 36 Gy in 12 daily fractions administered 5 days per week.
Related Therapeutic Areas
Sponsors
Leads: CHU de Quebec-Universite Laval

This content was sourced from clinicaltrials.gov