Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments hypofraction, standard
Phase phase 2
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborator Ferring Pharmaceuticals
Start date May 2012
End date May 2015
Trial size 30 participants
Trial identifier NCT01851018, H12-03-90, HYBRAFI

Summary

The purpose of this study is to compare toxicities between 2 external beam radiation fractionation schemes plus a brachytherapy boost for prostate cancer. Our current standard use a 2 Gy per fraction schedule which is compare to the experimental hypofractionated 3 Gy per day approach with neo adjuvant hormonal therapy. It will demonstrate the feasibility and safety of such a treatment regimen in prostate cancer. It may also set base for a larger randomized trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patient reported toxicities related to Hypofraction radiation treatment (3 Gy daily, 5 fractions per week) up to a total of 36 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant firmagon (240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL as a starting dose with a maintenance dose of 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL administered every 28 days).
hypofraction
Patient reported toxicities related to Hypofraction radiation treatment (3 Gy daily, 5 fractions per week) up to a total of 36 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant firmagon (240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL as a starting dose with a maintenance dose of 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL administered every 28 days).
(Active Comparator)
Patient reported toxicities related to the Standard radiation treatment (2 Gy daily, 5 fractions per week) up to a total of 44 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant LHRH agonists.
standard
Patient reported toxicities related to the Standard radiation treatment (2 Gy daily, 5 fractions per week) up to a total of 44 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant LHRH agonists

Primary Outcomes

Measure
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).
time frame: baseline, 6 weeks post-implant, and at 4,8,12 months
Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to gastro-intestinal (GI) toxicity score.
time frame: baseline, 6 weeks post-implant, and at 4,8,12 months
Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to Sexual toxicity (EPIC or SHIM) score.
time frame: baseline, 6 weeks post-implant, and at 4,8,12 months

Secondary Outcomes

Measure
Evaluate and compare biochemical disease free survival being non inferior to comparative cohort
time frame: 5 years

Eligibility Criteria

Male participants from 18 years up to 95 years old.

Inclusion Criteria: - 30 patients - intermediate / extensive low risk (all core biopsies involvements > 50%) - prostate cancer (not necessitating to treat the nodal regions) - Patient stage T1 - T2, - Gleason score ≤ 7, - PSA ≤ 20 will be considered Exclusion Criteria: - patient unfit for biopsy or brachytherapy - high or low risk prostate cancer

Additional Information

Official title 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
Principal investigator Andre-Guy Martin, MD MSc
Description 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 be considered. 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 vesicles. 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.