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Optimizing Prostate Cancer Treatment in Men With Advanced Local Disease (OPTiMAL)

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ClinicalTrials.gov Identifier: NCT03836196
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: LDR Brachytherapy and External Beam Radiation Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined radiation treatment
Combined low-dose-rate brachytherapy and external beam radiation therapy
Radiation: LDR Brachytherapy and External Beam Radiation Therapy
Low Dose Rate Brachytherapy (LDR-PB) and External Beam Radiation Therapy (EBRT)




Primary Outcome Measures :
  1. Frequency of treatment-related GU adverse effects [ Time Frame: Analysis to be done at median follow-up of 2 years ]
    Cumulative frequency of Physician-reported grade 2 and above GU adverse events (scored using a modified CTCAE - Common Terminology Criteria for Adverse Events- scale).


Secondary Outcome Measures :
  1. Trans-perineal biopsy and imaging correlation [ Time Frame: 2 years ]
    Correlations between trans-perineal biopsy and multi-modality, multi-parametric imaging provided by multi-parametric TRUS, multi-parametric MRI and PSMA PET/CT



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836196


Contacts
Contact: Michael Peacock, MD 6048776000 michael.peacock@bccancer.bc.ca

Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Michael Peacock, MD BCCANCER

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT03836196     History of Changes
Other Study ID Numbers: H18-01937
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by British Columbia Cancer Agency:
Prostate Cancer
PSMA PET/CT
multi-parametric MRI
multi-parametric TRUS
Transperineal mapping biopsy
LDR Brachytherapy
External Beam Radiation Treatment

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases