Status:
TERMINATED
Combined LDR Boost and HDR Whole Gland
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Carcinoma Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprosta...
Detailed Description
Eligible patients will have low and intermediate risk prostate cancer with a dominant intraprostatic lesion definable on multi parametric MRI (PIRADS 4 or 5). Patients will have MR planned LDR focal b...
Eligibility Criteria
Inclusion
- Confirmed Adenocarcinoma of the prostate
- Single PIRADS 4 or 5 lesion on multiparametric MRI
- T1c-T2b on rectal exam
- Gleason 3+3 and PSA \< 20ng/mL
- Gleason 3+4 and PSA \<10ng/mL
- Less than 50% of the cores positive in an untargeted prostate biopsy.
- Prostate volume \< 60 cc
Exclusion
- Incapable or ineligible for MRI imaging
- Previous trans-urethral resection of prostate (TURP)
- Previous or current use of androgen deprivation
- Baseline International Prostate Symptom Score (IPSS) \> 15
- Evidence of distant or nodal metastasis
- Disease that contraindicates treatment with radiation (e.g connective tissue disease)
- Unsuitable for anesthesia due to comorbidity
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03323879
Start Date
October 30 2017
End Date
July 1 2020
Last Update
April 27 2021
Active Locations (1)
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1
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N3M5