Combined Radiation Therapy for Prostate Cancer
(OPTiMAL Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on blood thinners, you must be able to stop them safely for at least 5 days.
What data supports the effectiveness of this treatment for prostate cancer?
Research shows that low-dose-rate (LDR) brachytherapy, a part of the combined radiation therapy, is effective for treating localized prostate cancer, achieving up to 90% relapse-free outcomes in low-risk cases over 10 years. Additionally, combining LDR brachytherapy with external radiation therapy can lead to 80-90% relapse-free outcomes in intermediate- and high-risk cases.12345
Is combined radiation therapy for prostate cancer safe for humans?
How is LDR Brachytherapy different from other prostate cancer treatments?
LDR Brachytherapy for prostate cancer involves implanting small radioactive seeds directly into the prostate, providing targeted radiation over a long period, which is different from external radiation that targets the prostate from outside the body. This method is minimally invasive and can be used alone for low-risk tumors or combined with other therapies for higher-risk cases, offering a high chance of long-term cancer control.12468
What is the purpose of this trial?
Multi-modality therapy that includes a brachytherapy implant improves outcomes in locally advanced prostate cancer when compared to other radiation-based treatments, but is also associated with more adverse side effects. The goal of the OPTiMAL trial is to reduce these side effects by using advanced imaging and biopsy techniques to locate cancer and deliver precision radiation therapy, while not compromising the unprecedented high cure rates obtained for the brachytherapy arm of the Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (ASCENDE-RT) randomized control trial.Additionally, some applied research in genetics, pathology and medical imaging is included. Novel medical imaging methods, namely, multi-parametric magnetic resonance imaging (MRI), multi-parametric trans-rectal ultrasound (TRUS), prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) are used for re-staging of prostate cancer. This is followed by trans-perineal biopsy to locate cancerous areas of the prostate with greater precision compared to conventional biopsy. Results from imaging are compared to those from biopsy to develop image-based cancer detection methods.
Research Team
Michael Peacock, MD
Principal Investigator
BCCANCER
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Re-staging
Participants undergo advanced imaging and trans-perineal biopsy to determine appropriate multi-modality therapy components
Treatment
Participants receive a combination of 125 iodine LDR-PB implant followed by EBRT, with possible androgen deprivation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on GU adverse effects
Treatment Details
Interventions
- External Beam Radiation Therapy
- LDR Brachytherapy
LDR Brachytherapy is already approved in United States, European Union, Canada for the following indications:
- Prostate cancer
- Prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
British Columbia Cancer Agency
Lead Sponsor