Status:
COMPLETED
HDR Brachytherapy as Monotherapy for Low and Intermediate Risk Prostate Cancer
Lead Sponsor:
CR-CSSS Champlain-Charles-Le Moyne
Conditions:
Prostate Cancer
Eligibility:
MALE
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate High-dose rate (HDR) brachytherapy (1 vs 2 fractions on single implant) as monotherapy for the treatment of low risk and intermediate risk prostate cancer
Detailed Description
INTRODUCTION: Several modalities of radiotherapy treatments are available for low and intermediate risk of prostate cancer, all avec similar results on biochemical control and toxicities. Among them,...
Eligibility Criteria
Inclusion
- Histologically proven prostate adenocarcinoma
- Clinical Stage T1c - T2c
- Gleason Score between 6 and 7
- PSA \< 15 ng / ml
- Prostate volume \< 70 cc as determined by ultrasound or IRM
- Signed informer consent
- Clinical conditions for complete diagnosis checkup and treatment procedure
- Should be able to complete IIEFS,IPSS and QLQ-C30 questionnaires
- Bone and pelvic scan negative for metastasis
Exclusion
- Prior pelvis radiation
- Prior Transurethral resection of the prostate (TURP) (less than 6 months)
- International Prostate Symptom Score: IPSS \> 16
- Contraindication to radiotherapy
- No prior use of Androgen deprivation therapy (ADT)
- Observation: 5 alpha-reductase (5AR) inhibitors is authorized.
Key Trial Info
Start Date :
June 22 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2022
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT03424694
Start Date
June 22 2015
End Date
February 22 2022
Last Update
March 17 2022
Active Locations (1)
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1
Hôpital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1