Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment

Prostate Cancer Clinical Trial

— HyBraFi  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01851018
• Other study ID #: H12-03-90
• Secondary ID: HYBRAFI
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2012
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).
• 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

Locations

Country	Name	City	State
Canada	CHUdeQuebec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to gastro-intestinal (GI) toxicity score.	Comparison of the patient reported Gastro-intestinal toxicity scores through the follow-up between each treatment group.	baseline, 6 weeks post-implant, and at 4,8,12 months
Primary	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.	Comparison of the patient reported Sexual toxicity (EPIC or SHIM) scores through the follow-up between each treatment group.	baseline, 6 weeks post-implant, and at 4,8,12 months
Secondary	Evaluate and compare biochemical disease free survival being non inferior to comparative cohort	biochemical disease free survival (Phoenix definition)	5 years