Status:
UNKNOWN
Focal Therapy for Prostate Cancer - A Pilot Study of Focal Low Dose Rate Brachytherapy
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This project will develop and evaluate a treatment plan for prostate focal therapy based on low dose rate brachytherapy. The participants entering this study are those suitable for active surveillance...
Detailed Description
1. Purpose To test the efficacy, acute side effects and long term safety of Focal Therapy in Prostate Cancer, as compared to conventional radical lose dose radiation prostate brachytherapy (LDR-PB...
Eligibility Criteria
Inclusion
- Must be 18 years of age or older
- Must be able to give informed consent
- Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 6 cores taken
- The prostate cancer is considered suitable for a strategy of active surveillance as well as conventional radical treatment.
- No more than 2 cores from one lobe containing cancer
- Gleason sum no greater than 3+4 =7 in any one core
- Clinical T stage no higher than T2a
- Serum prostate-specific antigen (PSA) no higher than 10 ng/mL
- No previous radiation therapy to the pelvis
- No prior history of malignancy except non-melanoma skin cancer
- Must be suitable for general or spinal anesthesia
- Must not be on coumadin or other anticoagulants
- Must be suitable for multi-parametric MRI scan (excluded are those with significant renal impairment that would preclude the use of contrast agents and may exclude 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 prostheses; shrapnel, bullets, or other metal fragments retained in the body may be excluded as well.
Exclusion
- They are unable to participate in an MRI scan.
- They are unable to undergo general or spinal anesthesia.
- They are on anticoagulation therapy (blood thinners).
- They have had previous radiotherapy to the pelvis.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01830166
Start Date
May 1 2013
End Date
January 1 2019
Last Update
July 13 2017
Active Locations (1)
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1
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6