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Radiation
Ultra-Hypo vs Conventional IMRT for Prostate Cancer (PCS-XI Trial)
N/A
Recruiting
Led By Andre-Guy Martin, MD MSc FRCPC
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 baseline within the first year.
Awards & highlights
Summary
This trial compares the effectiveness of two radiation treatments for prostate cancer with the aim of finding which one is best.
Who is the study for?
This trial is for men with a specific type of prostate cancer that hasn't spread to other parts of the body. They should be at an intermediate to very high risk according to NCCN guidelines and have not had pelvic radiotherapy before. Men with autoimmune diseases like Lupus, past inflammatory bowel disease, advanced prostate cancer (stage M1), severe urinary symptoms even on medication, or bilateral hip replacements cannot join.
What is being tested?
The study compares two types of radiation therapy: ultra-hypo fractionated radiotherapy delivering higher doses per session versus standard or moderate hypo-fractionation with lower doses per session. Both methods are combined with HDR brachytherapy boost and hormone therapy as per NCCN guidelines. The main goal is to see if the new method is just as good without causing more side effects.
What are the potential side effects?
Possible side effects include urinary issues, bowel problems, sexual dysfunction, fatigue, skin reactions in treated areas, and potential risks associated with hormone therapy such as hot flashes and bone thinning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years (median)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years (median)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Non-inferiority analysis of early change in genito-urinary (GU) toxicities induced.
Non-inferiority analysis of early change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.
Non-inferiority analysis of early change in sexual health.
+5 moreSecondary study objectives
Non-inferiority analysis of 10 years Disease Free Survival.
Non-inferiority analysis of 10 years Metastasis Free Survival.
Non-inferiority analysis of 10 years Overall Survival.
+5 moreOther study objectives
Abdomino-Pelvis (thorax not compulsory) CT Scan in order to evaluate if metastasis are present or not.
Alkaline Phosphatase.
Blood urea nitrogen (BUN)
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ultra hypo fractionation radiation therapy (UHF)Experimental Treatment8 Interventions
5 radiation treatments (5 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given every other day over 2 weeks for a total of 25 Gy.
Group II: standard of care fractionation (SOC)Active Control8 Interventions
20-25 radiation treatments (range: 1,8 to 2,15 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given in 20-25 working day treatments over 4-5 weeks for a total of 43 Gy to 46 Gy.
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Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
171 Previous Clinical Trials
109,199 Total Patients Enrolled
12 Trials studying Prostate Cancer
3,342 Patients Enrolled for Prostate Cancer
TerSera Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
842 Total Patients Enrolled
Andre-Guy Martin, MD MSc FRCPCPrincipal InvestigatorAndre-Guy Martin MD Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of autoimmune diseases like Lupus.I have a history of inflammatory bowel disease.My cancer has spread to other parts of my body.My cancer has not spread to distant parts of my body.My condition is classified as intermediate to very high risk.My cancer has a risk of spreading to lymph nodes needing pelvic radiation.My prostate cancer is confirmed by a tissue examination.I have had radiation therapy to my pelvic area before.I can make my own medical decisions.My prostate symptoms are severe, even with medication.
Research Study Groups:
This trial has the following groups:- Group 1: standard of care fractionation (SOC)
- Group 2: ultra hypo fractionation radiation therapy (UHF)
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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