Recruiting

Prostate Cancer TreatmentOptimizing Prostate Cancer Treatment in Men With Advanced Local Disease

Sponsor:

British Columbia Cancer Agency

Code:

NCT03836196

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LDR Brachytherapy and External Beam Radiation Therapy

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT03836196

Start date

Sep 13, 2019

Status verified date

Feb, 2023

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

Those with pre-intervention prostate specific antigen (iPSA) above 100 ng/mL.
Those who have received 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)
Those with an estimated life expectancy of less than 5 years with an Eastern Cooperative Oncology Group (ECOG ) performance status above 0-2
Those with prior radiation therapy to the pelvis.
Those who have received androgen deprivation therapy (ADT) prior to registration.
Contraindication to high-dose pelvic irradiation, Luteinizing hormone-releasing hormone (LHRH) agonists, or nonsteroidal antiandrogen therapy
Those who are not able to participate in an MRI scan (i.e. significant renal impairment that would preclude the use of contrast agent, some patients with cardiac pacemaker, wires, or defibrillator; artificial heart valve; brain aneurysm clip; electrical stimulator for nerves or bones; ear or eye implant; implanted drug infusion pump; coil; catheter, or filter in any blood vessel. Some men with metallic prosthesis; shrapnel, bullets, or other metal fragments retained in the body)
Those who are not able to participate in a PET/CT scan
Cancer survivors who do not meet all three of the following criteria: a) The patient has undergone potentially curative therapy for all prior malignancies. b) There has been no evidence of recurrence for at least five years following potentially curative therapy. (For non-melanoma skin cancer the five-year requirement does not apply.) and c) The patient is considered by the treating physician to be at low risk of recurrence from prior malignancies.
Those who are on anticoagulation therapy (blood thinners) and are unable stop this medication safely for at least 5 days.

Study Design

Enrollment

105 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Combined radiation treatment

Combined low-dose-rate brachytherapy and external beam radiation therapy

Interventions

LDR Brachytherapy and External Beam Radiation Therapy

Low Dose Rate Brachytherapy (LDR-PB) and External Beam Radiation Therapy (EBRT)

Primary outcome measure

Frequency of treatment-related GU adverse effects [ Time Frame: Analysis to be done at median follow-up of 2 years ]

Central Contacts and Locations

Central contacts

Michael Peacock, MD

6048776000 michael.peacock@bccancer.bc.ca

Sara Mahdavi, PhD

6048776000 sara.mahdavi@bccancer.bc.ca

Locations

BC Cancer - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Sara Mahdavi, PhD

6048776000 sara.mahdavi@bccancer.bc.ca

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Feb 9, 2023

Last verified

Feb, 2023

Keywords

Prostate Cancer
PSMA PET/CT
multi-parametric MRI
multi-parametric TRUS
Transperineal mapping biopsy
LDR Brachytherapy
External Beam Radiation Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2023-02-09.