Clinical Trial

Optimizing Prostate Cancer Treatment in Men With Advanced Local Disease

Study acronym: OPTiMAL
Recruiting
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Record status
This record was last updated February 9, 2023 (before its estimated February 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-02-07; most recent amendment 2023-02-07.
Status change: Not Yet Recruiting → Recruiting 2019-07-08
Trial Details
NCT Number NCT03836196
Lead Sponsor British Columbia Cancer Agency
Conditions Prostate Cancer
Enrollment 105 participants
Start Date 2019-09-13
Primary Completion 2025-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2023-02-09