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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
OPTiMAL Trial 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.Check my eligibility
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.See study design
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.
OPTiMAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is considered high-risk or intermediate-risk with at least 3 points based on specific criteria.
Select...
My prostate cancer diagnosis was confirmed through a tissue sample.
Select...
My scans show no cancer spread to bones or lymph nodes.
OPTiMAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of treatment-related GU adverse effects
Secondary outcome measures
Trans-perineal biopsy and imaging correlation
OPTiMAL 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
171 Previous Clinical Trials
90,406 Total Patients Enrolled
23 Trials studying Prostate Cancer
5,707 Patients Enrolled for Prostate Cancer
Michael Peacock, MDPrincipal InvestigatorBCCANCER
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is considered high-risk or intermediate-risk with at least 3 points based on specific criteria.You are unable to undergo a PET/CT scan.I am a cancer survivor considered at low risk of recurrence, with no signs of cancer for at least 5 years.I cannot have an MRI due to certain medical devices or conditions.I cannot undergo high-dose pelvic radiation or certain hormone therapies.I have undergone hormone therapy for cancer before signing up.I cannot safely stop my blood thinner medication for 5 days.I have had radiation therapy to my pelvis.My doctor thinks I have less than 5 years to live and I can't care for myself.My prostate cancer diagnosis was confirmed through a tissue sample.I have had surgery for prostate cancer, such as TURP, cryotherapy, or HIFU.My scans show no cancer spread to bones or lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: Combined radiation treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings left in this clinical experiment?
"Affirmative. Clinicaltrials.gov's records show that this trial, which was initially published on September 13th 2019, is recruiting participants at the moment. There are 105 patient positions to be filled from a single medical centre."
Answered by AI
What is the current cohort size of this experiment?
"Affirmative. Clinicaltrials.gov has records indicating that this clinical trial, which was instituted on September 13th 2019, is actively seeking applicants. 105 individuals are expected to join from 1 medical centre throughout the course of the study."
Answered by AI
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