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Hypofraction 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

HyBraFi Trial 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.Check my eligibility

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.See study design

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.

HyBraFi Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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).

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 outcome measures

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

HyBraFi 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ferring PharmaceuticalsIndustry Sponsor

314 Previous Clinical Trials

440,853 Total Patients Enrolled

51 Trials studying Prostate Cancer

17,837 Patients Enrolled for Prostate Cancer

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

107,127 Total Patients Enrolled

12 Trials studying Prostate Cancer

3,812 Patients Enrolled for Prostate Cancer

Andre-Guy Martin, MD MScPrincipal InvestigatorCHUQ L'Hotel Dieu de Quebec

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the experimental study permit participants younger than twenty-five to take part?

"Potential participants need to meet specific age criteria; they must be no younger than 18 and no older than 95."

Answered by AI

Which individuals are eligible to participate in this investigation?

"All candidates must be between 18 and 95 years old, have a diagnosis of prostate cancer in order to qualify for this study. There is space for 30 patients in total."

Answered by AI

What potential risks does Hypofraction present to individuals?

"We estimate that Hypofraction's safety rating stands at 2 due to data suggesting its efficacy not yet being available, although there is some evidence of its protection."

Answered by AI

Are recruitment efforts underway for this clinical research?

"Clinicaltrials.gov has reported that this specific study, which was initially posted on May 1st 2012 and last edited on May 8th 2013, is not enrolling participants at the moment. Notwithstanding this fact, there are currently 1308 other medical studies actively looking for patients to volunteer in their trials."

Answered by AI

Recent research and studies

Critical Reviews in Oncology/HematologyJournal

Is High Dose Rate Brachytherapy Reliable and Effective Treatment for Prostate Cancer Patients? A Review of the Literature

De Bari, Berardino, Antonino Daidone, and Filippo Alongi. 2015. “Is High Dose Rate Brachytherapy Reliable and Effective Treatment for Prostate Cancer Patients? A Review of the Literature”. Critical Reviews in Oncology/hematology. Elsevier BV. doi:10.1016/j.critrevonc.2015.02.003.

clinicaltrials.govStudy

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

André-Guy Martin 2012. "Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01851018.

All > Toxicity