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Brachytherapy

HDR vs LDR Brachytherapy for Prostate Cancer (BrachyQOL Trial)

N/A

Waitlist Available

Led By Francois Bachand, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High risk prostate cancer with one of the following factors: T3a, Gleason Score 8-10, PSA > 20, Positive prostate biopsy within 6 months (reviewed centrally), International Prostate Symptom Score < 16, Prostate volume < 60 cc, Negative staging CT and Bone scan within 3 months prior to registration, History and physical examination within 90 days prior to registration, European Cooperative Oncology Group performance status 0-1 prior to registration, Age > 45, Patient suitable for procedure under anesthesia

Upper tier intermediate risk with at least 2 of the following factors: Tumor-Nodes-Metastases Tumor stage T2B or greater, Gleason Score 7, PSA > 10, > 50% of the biopsies positive

Must not have

Previous prostatectomy, cryotherapy or High Intensity Focussed Ultrasound for prostate cancer

Previous pelvic irradiation or prostate brachytherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a high dose or low dose of radiation is better for treating prostate cancer without surgery. They also want to know if there are any side effects from either dose and if quality of life is affected.

Who is the study for?

This trial is for men with intermediate to high-risk prostate cancer, who have not had surgery. They must have at least two of certain risk factors like a tumor stage T2B or higher, Gleason Score of 7, PSA over 10, or more than half their biopsies positive; or one high-risk factor like T3a stage, Gleason Score 8-10, or PSA over 20.

What is being tested?

The study compares two types of brachytherapy 'boosts' added to external beam radiotherapy for prostate cancer: High Dose Rate (HDR) and Low Dose Rate (LDR). It aims to see if HDR leads to better survival rates without the disease getting worse and has fewer side effects and improved life quality compared to LDR.

What are the potential side effects?

Potential side effects from both HDR and LDR brachytherapy may include discomfort at the treatment site, urinary issues such as frequency or urgency, bowel changes like diarrhea, erectile dysfunction, and fatigue.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is intermediate risk with at least 2 of these: T2B or higher stage, Gleason Score 7, PSA over 10, more than half of biopsies positive.

Exclusion Criteria

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

Select...

I have had surgery or specific treatments for prostate cancer.

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I have had radiation treatment to my pelvis or seed implant therapy in my prostate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compare Quality of Life between two arms as measured by EPIC questionnaire

Secondary study objectives

Quality of Life long term

Other study objectives

Efficacy: cancer free status

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: LDR boostActive Control1 Intervention

After completion of 46 Gy of external beam radiotherapy subjects will undergo a permanent seed radioactive implant to the prostate using iodine-125 seeds to deliver a dose of 110 Gy

Group II: HDR boostActive Control1 Intervention

Subjects in this arm will undergo an HDR implant to deliver 15 Gy to the prostate prior to commencing the external beam component of their treatment.

0 / 4Eligibility criteria met