Match Pair Analysis Study, Comparing Toxicities Between 2 Treatment Regiments Including Neo-adjuvant Hormonal Therapy Plus Hypofractionated RT With HDR Brachytherapy Boost Compare to Our Current Clinical Standard Approach at CHU de Quebec
30 patients with intermediate / extensive low risk (all core biopsies involvements > 50%)
prostate cancer (not necessitating to treat the nodal regions) will be included in this
study. Patient stage T1 - T2, Gleason score ≤ 7, prostate-specific antigen (PSA) ≤ 20 will
Fiducial gold markers will be introduced in the prostate 1-week before the CT planning. 36
gray (Gy) in 12 fractions using intensity-modulated radiation therapy (IMRT) will be
administered to the prostate (margins of 0,5cm) +/- first centimeter of the seminal
Brachytherapy boost (15 Gy x 1) dosimetric parameters should respect our current standard
(Prostate V100 > 90% and V150 ≤ 40%, V200 ≤ 15%, Urethra V125 ≤ 1 cc, Rectum V75 ≤ 1cc,
Bladder V75 ≤ 1cc). Short course (4 months) hormonal therapy (Degarelix) will be
administered to the patient based upon recommended litterature11, 12.
Genitourinary (GU), GI and Sexual toxicity will be self reported. QOL questionnaires will be
given to the patients to be answered. Results will be monitored and compared to our
currently used standard fractionation regiment.
Follow-up will be scheduled 6 weeks after the implant and every 4 months for the first year,
every 6 months for the second year 2 to 5, and on a yearly basis after 5 years. PSA &
testosterone tests will be done every 3 months for the first 3 years, every 6 months on
years 4 and 5, and yearly thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to Median international prostate symptoms scores (IPSS).
Comparison of the patient reported IPSS scores through the follow-up between each treatment group.
baseline, 6 weeks post-implant, and at 4,8,12 months
Andre-Guy Martin, MD MSc
CHUQ L'Hotel Dieu de Quebec
Canada: Public Health Agency of Canada