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Brachytherapy

Combined Radiation Therapy for Prostate Cancer (OPTiMAL Trial)

N/A
Recruiting
Led By Michael Peacock, 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
Patients must meet either: a. National Comprehensive Cancer Network (NCCN) definition of high-risk disease or b. Intermediate-risk disease with at least 3 points using the following scale: One point each for clinical stage = T2b-c, iPSA >7 ng/mL, and Gleason grade group 2 (overall Gleason sum 3+4 =7), Two points for Gleason grade group 3 (overall Gleason sum 4+3 =7).
Patients must have histologically-proven prostate cancer
Must not have
Contraindication to high-dose pelvic irradiation, Luteinizing hormone-releasing hormone (LHRH) agonists, or nonsteroidal antiandrogen therapy
Those who have received androgen deprivation therapy (ADT) prior to registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to deliver radiation therapy to prostate cancer patients that is more precise and may have fewer side effects than the current standard of care.

Who is the study for?
Men with advanced local prostate cancer who have not received prior treatments like surgery or hormone therapy, and are fit enough for the trial (ECOG performance status 0-2). They must have a life expectancy over 5 years and be able to undergo MRI and PET/CT scans. The trial is specifically for those with high-risk disease as defined by NCCN or intermediate-risk disease meeting certain criteria.
What is being tested?
The OPTiMAL trial tests whether precision radiation therapy using advanced imaging techniques can reduce side effects in treating locally advanced prostate cancer. It aims to maintain high cure rates seen in previous studies while minimizing harm through targeted brachytherapy combined with external beam radiation.
What are the potential side effects?
Potential side effects include urinary issues, bowel problems, sexual dysfunction, fatigue, skin irritation near treatment areas, and inflammation due to radiation exposure. Advanced imaging aims to minimize these by precisely targeting cancerous tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is considered high-risk or intermediate-risk with at least 3 points based on specific criteria.
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My prostate cancer diagnosis was confirmed through a tissue sample.
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My scans show no cancer spread to bones or lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo high-dose pelvic radiation or certain hormone therapies.
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I have undergone hormone therapy for cancer before signing up.
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I have had radiation therapy to my pelvis.
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My doctor thinks I have less than 5 years to live and I can't care for myself.
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I have had surgery for prostate cancer, such as TURP, cryotherapy, or HIFU.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Frequency of treatment-related GU adverse effects
Secondary study objectives
Trans-perineal biopsy and imaging correlation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combined radiation treatmentExperimental Treatment1 Intervention
Combined low-dose-rate brachytherapy and external beam radiation therapy

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor
176 Previous Clinical Trials
95,123 Total Patients Enrolled
21 Trials studying Prostate Cancer
4,103 Patients Enrolled for Prostate Cancer
Michael Peacock, MDPrincipal InvestigatorBCCANCER

Media Library

LDR Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03836196 — N/A
Prostate Cancer Research Study Groups: Combined radiation treatment
Prostate Cancer Clinical Trial 2023: LDR Brachytherapy Highlights & Side Effects. Trial Name: NCT03836196 — N/A
LDR Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03836196 — N/A
~2 spots leftby Feb 2025
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