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Radiotherapy Options for Prostate Cancer (HyBraFi Trial)

N/A

Waitlist Available

Led By Andre-Guy Martin, MD MSc

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares 2 types of radiation treatment for prostate cancer, to see if one is safer and more effective. Results may lead to a larger trial.

Who is the study for?

This trial is for up to 30 men with a specific stage of prostate cancer (T1-T2), where the cancer hasn't spread to lymph nodes. They should have a Gleason score of 7 or less, and PSA levels at or below 20. It's not suitable for those needing treatment beyond the prostate.

What is being tested?

The study compares two radiation treatments for prostate cancer: standard therapy using daily doses of radiation versus an experimental approach that gives larger doses less often, both followed by brachytherapy boost and hormone therapy.

What are the potential side effects?

Potential side effects include irritation to the bladder and bowel, fatigue, sexual dysfunction, urinary issues, and skin reactions in the treated area. The intensity may vary between standard and hypofractionated therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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).

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.

Evaluate and compare toxicity changes through follow-up between our study population and a reference group in regards to gastro-intestinal (GI) toxicity score.

Secondary study objectives

Evaluate and compare biochemical disease free survival being non inferior to comparative cohort

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HypofractionExperimental Treatment1 Intervention

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).

Group II: StandardActive Control1 Intervention

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.

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