No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Interventional
Purpose
Health Services Research
Participants needed
105 (estimated)
Sponsor
British Columbia Cancer Agency · Other
Who this trial is looking for
This trial is looking for men with advanced prostate cancer to test new imaging methods that help locate cancer more accurately. Participants will receive a special type of radiation treatment aimed at improving outcomes while reducing side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with prostate cancer.
I have high-risk or certain intermediate-risk prostate cancer.
I have no cancer spread to my bones or other organs.
You may not be able to join if
My prostate-specific antigen (iPSA) level is above 100 ng/mL.
I have had previous surgery for prostate cancer.
I have had radiation therapy to the pelvic area before.
I cannot undergo an MRI or a PET/CT scan.
I am on blood thinners and cannot stop them safely for 5 days.
I have a life expectancy of less than 5 years.
I have received hormone therapy for prostate cancer before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 c…
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.
Trial Locations
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Eligibility 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 s…
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.
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