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New treatment option for Prostate Cancer
Official title Optimizing Prostate Cancer Treatment in Men With Advanced Local Disease
ClinicalTrials.gov ID: NCT03836196
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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...
- Patients must have N0 M0 status on the basis of technetium bone scan and computed tomography (CT) scan of the pelvis
You likely can't join 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...
- 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
See the full eligibility 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...
- Patients must have N0 M0 status on the basis of technetium bone scan and computed tomography (CT) scan of the pelvis
- 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...
- 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...
- 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...
- Those who are on anticoagulation therapy (blood thinners) and are unable stop this medication safely for at least 5 days.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.