Actively Recruiting
Optimizing Prostate Cancer Treatment in Men With Advanced Local Disease
Led by British Columbia Cancer Agency · Updated on 2023-02-09
105
Participants Needed
1
Research Sites
437 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing Prostate Cancer Treatment in Men With Advanced Local Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically-proven prostate cancer
- 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 N0 M0 status on the basis of technetium bone scan and computed tomography (CT) scan of the pelvis
You will not qualify if you...
- Pre-intervention prostate specific antigen (iPSA) above 100 ng/mL
- Prior surgical treatment for prostate cancer including transurethral resection of the prostate (TURP), transurethral resection of the bladder neck (TURB), cryotherapy, laser ablation, or high frequency ultrasound (HIFU)
- Estimated life expectancy of less than 5 years with an Eastern Cooperative Oncology Group (ECOG) performance status above 0-2
- Prior radiation therapy to the pelvis
- Prior androgen deprivation therapy (ADT) before registration
- Contraindication to high-dose pelvic irradiation, Luteinizing hormone-releasing hormone (LHRH) agonists, or nonsteroidal antiandrogen therapy
- Unable to participate in MRI scan due to renal impairment, implanted devices, or metal fragments
- Unable to participate in PET/CT scan
- Cancer survivors who do not meet all three criteria: a) undergone potentially curative therapy for all prior malignancies, b) no recurrence for at least five years (except non-melanoma skin cancer), c) considered low risk of recurrence by physician
- On anticoagulation therapy and unable to safely stop medication for at least 5 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
BC Cancer - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
Research Team
M
Michael Peacock, MD
CONTACT
S
Sara Mahdavi, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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