Status:
ACTIVE_NOT_RECRUITING
LDR vs. HDR Brachytherapy for Prostate Cancer
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
BC Cancer Foundation
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
Phase:
NA
Brief Summary
H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a...
Detailed Description
Men suitable for prostate brachytherapy as monotherapy will undergo multiparametric Magnetic Resonance Imaging for staging and identification of a dominant lesion and will be randomly selected for eit...
Eligibility Criteria
Inclusion
- Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.
- Clinical stage T1c-T2b, PSA \< 20, Gleason \< 8
- ECOG 0-1
- Low tier intermediate-risk prostate cancer is defined by a single NCCN intermediate risk factor
- Extensive favorable-risk disease is defined as:
- clinical stage T1c-T2a
- PSA \< 10
- Gleason 6
- ≥ 50% of biopsy cores containing cancer
- PSA density \> 0.2 ng/cc
- Selected intermediate risk patients not defined above
- \- T1c/T2a
- \- PSA \< 10
- -Gleason 4+3
- -\< 33% of cores involved
- -Max tumor length in any core 10 mm
- No androgen deprivation therapy (ADT)
- Prostate volume by TRUS ≤ 60 cc.
- Not eligible for, or accepting of, active surveillance according to NCCN guidelines.
- Signed study specific informed consent.
Exclusion
- Prior radical surgery for carcinoma of the prostate,
- Prior pelvic radiation
- Prior chemotherapy for prostate cancer,
- Prior TURP or cryosurgery of the prostate
- Claustrophobic or unable to undergo MRI
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03426748
Start Date
February 15 2018
End Date
December 31 2026
Last Update
March 13 2025
Active Locations (1)
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1
British Columbia Cancer Agency Center for the Southern Interior
Kelowna, British Columbia, Canada, V1Y5L3