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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.

Must not have

Gleason score ≥ 4 + 3.

Prior radical surgery for carcinoma of the prostate, or prior TURP (Trans-Urethral Resection of the Prostate).

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

No Placebo-Only Group

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.

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.

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

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

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

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My prostate symptoms are mild to moderate.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I am not on any hormonal therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer has a Gleason score of 7 or higher.

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I have had major surgery for prostate cancer or a TURP procedure.

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I have a bleeding condition that makes certain cancer treatments unsafe for me.

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My cancer has spread to other parts of my body or lymph nodes.

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I have had radiation therapy in the pelvic area before.

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I have undergone hormone therapy for cancer within the last 6 months.

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My cancer is at least stage T2b.

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I have had cryosurgery on my prostate before.

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.