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Clinical Trials/NCT02918253
NCT02918253
Recruiting
Not Applicable

HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields

University Health Network, Toronto1 site in 1 country30 target enrollmentOctober 14, 2016
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University Health Network, Toronto
Enrollment
30
Locations
1
Primary Endpoint
number of patients achieving biochemical control
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer, traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR) brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence adverse effects including urinary, rectal, and sexual toxicities that affect the patient's quality of life.

This study will incorporate HDR monotherapy treatment option for early stages and favourable risk prostate cancer.

Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined disease based on multiparametric MRI (mpMRI). This approach may offer an option of reducing the treatment toxicities while maintaining oncologic outcomes when compared with whole-gland therapy. Advantages in quality of life could be exhibited in the form of reduced urinary discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland function. This study would be particularly relevant in the current era of earlier localized prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine component of patient care.

Registry
clinicaltrials.gov
Start Date
October 14, 2016
End Date
December 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • ECOG performance status 0 - 2
  • Histological evidence of prostate adenocarcinoma
  • Low- and favorable intermediate-risk prostate cancer
  • Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
  • No contraindications to MRI:
  • Absent or unifocal intraprostatic disease (\<2 separate/distinct lesions), on multiparametric MRI
  • Prostate gland size \<80cc
  • Baseline IPSS \<18
  • No TRUP within the past 6 months, nor large TURP defect

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

number of patients achieving biochemical control

Time Frame: 2 yrs

Study Sites (1)

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