← Back to Search

Brachytherapy

SBRT vs LDR Brachytherapy for Prostate Cancer

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

Low-risk disease defined as: Clinical stage T1-T2a and Gleason 6 and PSA ≤ 10 ng/mL

Prostate volume ≤ 60 cc, measured by Trans-Rectal UltraSound (TRUS), CT or MRI, within the last 6 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up psa measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years

Awards & highlights

Study Summary

This trial will compare SBRT to LDRB in prostate cancer patients to see if SBRT has fewer side effects and better quality of life.

Who is the study for?

Men over 18 with low to favorable intermediate-risk prostate cancer, who are medically fit for brachytherapy and have not had hormonal therapy or certain other treatments. They must have a performance status of 0-1, an IPSS ≤ 20, no history of severe comorbidities that would interfere with the trial, and agree to fill out specific questionnaires.Check my eligibility

What is being tested?

This study compares two types of radiation therapy: SBRT (a precise external beam technique) versus LDRB (internal radiation using Iodine-125 seeds). It's designed to see which causes fewer urinary/gastrointestinal side effects and leads to better quality of life in patients with localized prostate cancer.See study design

What are the potential side effects?

Potential side effects include urinary issues like burning or increased frequency, bowel changes such as diarrhea or discomfort, fatigue from treatment stress on the body, skin irritation around treated areas, and erectile dysfunction due to nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer is early stage, with low Gleason score and PSA levels.

Select...

My prostate is 60 cc or smaller, confirmed by a recent scan.

Select...

My prostate symptoms are mild to moderate.

Select...

I am 18 years old or older.

Select...

I am fully active or can carry out light work.

Select...

I am not on any hormonal therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ psa measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~psa measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and psa measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 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

Adverse Event Evaluation according to the CTCAE version 4 to assess non-inferiority of SBRT compared to LDRB.

Secondary outcome measures

Absolute PSA nadir to evaluate biochemical disease free survival.

Quality of life issues in patients with prostate cancer

Urinary function

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stereotactic Body Radiation Therapy to the prostateExperimental Treatment1 Intervention

Stereotactic Body Radiation Therapy to the prostate using 36.25 Gy in 5 fractions.

Group II: Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implantActive Control1 Intervention

Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant to a total dose of 144 Gy.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

106,949 Total Patients Enrolled

12 Trials studying Prostate Cancer

3,634 Patients Enrolled for Prostate Cancer

Isabelle Thibault, MD, FRCPCStudy ChairCHU de Québec-Université Laval

Frequently Asked Questions

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

Is the recruitment of participants still in progress for this research?

"Indeed, the information on clinicaltrials.gov exhibits that this investigation is currently enrolling subjects. This trial was first published on September 30th 2019 and revised most recently on September 21st 2023. It seeks to recruit 208 people at one centre of research."

Answered by AI

What is the aggregate figure of participants involved in this research study?

"Affirmative. According to clinicaltrials.gov, this research study was published on 30th September 2019 and has recently been modified as of 21st September 2023. The project is recruiting 208 participants at a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.

2019. "A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052683.

All > Toxicity