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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

PCS-XI Trial 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.Check my eligibility
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.See study design
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.

PCS-XI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years (median)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years (median) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more
Other outcome measures
Abdomino-Pelvis (thorax not compulsory) CT Scan in order to evaluate if metastasis are present or not.
Alkaline Phosphatase.
Blood urea nitrogen (BUN)
+9 more

PCS-XI Trial 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.

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
106,657 Total Patients Enrolled
TerSera Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
949 Total Patients Enrolled
Andre-Guy Martin, MD MSc FRCPCPrincipal InvestigatorAndre-Guy Martin MD Inc.

Media Library

Conventionally Fractionated IMRT with HDR Boost (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05820633 — N/A
Prostate Node Research Study Groups: standard of care fractionation (SOC), ultra hypo fractionation radiation therapy (UHF)
Prostate Node Clinical Trial 2023: Conventionally Fractionated IMRT with HDR Boost Highlights & Side Effects. Trial Name: NCT05820633 — N/A
Conventionally Fractionated IMRT with HDR Boost (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05820633 — N/A

Frequently Asked Questions

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

Am I eligible to sign up for this clinical examination?

"To be accepted, 500 people aged between 18 and 95 who have been diagnosed with prostate cancer will need to apply."

Answered by AI

Is it possible for individuals aged 50 or more to participate in this experiment?

"This clinical trial can only accept applicants between the ages of 18 to 95. For younger and elderly individuals, there are 67 trials open for those under 18 and 1343 studies available for people over 65."

Answered by AI

What is the approximate size of this clinical research's recruitment?

"Affirmative. According to information accessible on clinicaltrials.gov, this research project is presently looking for volunteers and was posted online on the 1st of September 2022; the data has been recently updated on April 7th 2023. This investigation needs 500 individuals across a single medical facility to participate."

Answered by AI

Is enrollment still ongoing for this research project?

"Indeed, the information posted on clinicaltrials.gov confirms that this medical research is recruiting test subjects. It was first listed online on September 1st 2022 and has gone through subsequent revisions as recently as April 7th 2023. The study requires 500 participants to be enrolled at one location."

Answered by AI

What is the overarching objective of this research trial?

"TerSera Therapeutics LLC, the trial sponsor, is assessing primary outcomes every 3 months for 1 year. Specifically, they are conducting a non-inferiority analysis of late change in genito-urinary (GU) toxicities induced. Additionally, there will be secondary endpoints such as comparing 5 years Disease Free Survival and Metastasis Free Survival between two groups through a non-inferiority approach as well as evaluating five years Overall Survival with an intent to measure any lack of inferiority."

Answered by AI
Recent research and studies
~300 spots leftby Nov 2026