HyBraFi: Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Radiation: 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: 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. |
Radiation: 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
|
Outcome Measures
Primary Outcome Measures
- 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). [baseline, 6 weeks post-implant, and at 4,8,12 months]
Comparison of the patient reported IPSS scores through the follow-up between each treatment group.
- Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to gastro-intestinal (GI) toxicity score. [baseline, 6 weeks post-implant, and at 4,8,12 months]
Comparison of the patient reported Gastro-intestinal toxicity scores through the follow-up between each treatment group.
- 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. [baseline, 6 weeks post-implant, and at 4,8,12 months]
Comparison of the patient reported Sexual toxicity (EPIC or SHIM) scores through the follow-up between each treatment group.
Secondary Outcome Measures
- Evaluate and compare biochemical disease free survival being non inferior to comparative cohort [5 years]
biochemical disease free survival (Phoenix definition)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHUdeQuebec | Quebec | Canada | G1R 2J6 | |
| 2 | CHUQ L'Hotel-Dieu de Quebec | Quebec | Canada | G1R 2J6 |
Sponsors and Collaborators
- CHU de Quebec-Universite Laval
- Ferring Pharmaceuticals
Investigators
- Principal Investigator: Andre-Guy Martin, MD MSc, CHUQ L'Hotel Dieu de Quebec
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H12-03-90
- HYBRAFI