Optimizing Prostate Cancer Treatment in Men With Advanced Local Disease

NCT03836196 | Recruiting DMC

• 1 other identifier: H18-01937
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Frequency of treatment-related GU adverse effects

  Cumulative frequency of Physician-reported grade 2 and above GU adverse events (scored using a modified CTCAE - Common Terminology Criteria for Adverse Events- scale).

  Analysis to be done at median follow-up of 2 years

Secondary Outcomes (1)

• Trans-perineal biopsy and imaging correlation

  2 years

Study Arms (1)

Combined radiation treatment

EXPERIMENTAL

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

Radiation: LDR Brachytherapy and External Beam Radiation Therapy

Interventions

LDR Brachytherapy and External Beam Radiation Therapy RADIATION

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

Combined radiation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Peacock, MD

  BCCANCER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Peacock, MD

CONTACT

6048776000; michael.peacock@bccancer.bc.ca

Sara Mahdavi, PhD

CONTACT

6048776000; sara.mahdavi@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: February 11, 2019
• Study Start: September 13, 2019
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

CA (1)