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Brachytherapy
Ultra-Hypofractionated Radiotherapy + Brachytherapy for Prostate Cancer (HYPO-5 Trial)
N/A
Recruiting
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 at 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two different radiation therapies for prostate cancer, looking at toxicity, acceptability, and long-term success rates.
Who is the study for?
Men with early-stage prostate cancer (Stage T1c or T2), no spread to lymph nodes or distant organs, PSA levels below 20ng/ml, and a Gleason Score of 6 or 7. Participants must be able to give written consent. Excluded are those with advanced disease stages, high Gleason Scores (8-10), severe urinary symptoms, prior pelvic radiotherapy, bilateral hip prosthesis, under age 18, inflammatory bowel disease history, or active collagen diseases.
What is being tested?
This Phase 1-2 study compares two types of radiation therapy for prostate cancer: ultra-hypofractionnated versus moderately hypofractionnated therapy combined with image-guided HDR brachytherapy. The goal is to determine if the shorter treatment is just as safe as the longer one in terms of side effects over time.
What are the potential side effects?
Potential side effects include typical reactions from radiation such as skin irritation near the treated area, fatigue during and after treatment sessions, urinary issues like discomfort or frequency increase and potential bowel changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
GI toxicity analysis (CTCAE)
GU toxicity analysis (CTCAE)
quality of life questionnaires analysis (EPIC26)
+2 moreSecondary study objectives
Clinical outcomes
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: ultra hypo fractionation radiation therapyExperimental Treatment1 Intervention
comparative PRO's of 25 Gy in 5 daily fractions (Ultra hypo fractionation) administered to prostate and 1st centimeter of proximal seminal vesicle, starting mid week and ending mid following week.
Group II: moderate hypo fractionation radiation therapyActive Control1 Intervention
PRO's of moderate hypo fractionation, 37,5 Gy in 15 or 36 Gy in 12 daily fractions administered 5 days per week.
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Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
171 Previous Clinical Trials
109,400 Total Patients Enrolled
Andre-Guy MartinStudy ChairCHU de Québec
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy to my pelvic area before.I have a history of autoimmune diseases like Lupus.I have a history of inflammatory bowel disease.My cancer has spread to nearby lymph nodes.My IPSS score is over 20 despite being on medication for urinary symptoms.My cancer is in a late stage, but has not spread to distant organs.I am under 18 years old.My cancer has not spread to distant parts of my body.My prostate cancer has a Gleason score of 6 or 7.I can sign a consent form.My prostate cancer was confirmed through a biopsy.My cancer is at an early stage, but not the earliest.My cancer has not spread to nearby lymph nodes.My prostate cancer is aggressive (Gleason Score 8-10).My cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: ultra hypo fractionation radiation therapy
- Group 2: moderate hypo fractionation radiation therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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