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Optimizing the Management of High-risk and Unfavorable Intermediate-risk Disease: the Use of Advanced Imaging, Trans-perineal Mapping Biopsies, and Dual-strength Brachytherapy Sources to Minimize Radiation Dose to Normal Tissues

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
BC Cancer - Vancouver
RECRUITING
Vancouver
Contact Information
Primary
Michael Peacock, MD
michael.peacock@bccancer.bc.ca
6048776000
Backup
Sara Mahdavi, PhD
sara.mahdavi@bccancer.bc.ca
6048776000
Time Frame
Start Date: 2019-09-13
Estimated Completion Date: 2028-02
Participants
Target number of participants: 105
Treatments
Experimental: Combined radiation treatment
Combined low-dose-rate brachytherapy and external beam radiation therapy
Related Therapeutic Areas
Sponsors
Leads: British Columbia Cancer Agency

This content was sourced from clinicaltrials.gov

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