A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2020-05-01

Brief Summary

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A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.

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Detailed Description

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Conditions

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Carcinoma of the Prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HDR 2 fractions

HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart

Group Type EXPERIMENTAL

HDR 2 Fraction

Intervention Type RADIATION

High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.

HDR 1 fraction

HDR brachytherapy of 19 Gy delivered in a single fraction

Group Type EXPERIMENTAL

HDR 1 Fraction

Intervention Type RADIATION

High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction

Interventions

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HDR 2 Fraction

High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.

Intervention Type RADIATION

HDR 1 Fraction

High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed diagnosis of adenocarcinoma of the prostate
* low and intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA \< 20ng/mL. PSA to be drawn within 60 days of registration
* prostate volume \< 60 cc as determined by ultrasound, CT or MRI
* willing to give informed consent ot participate in this clinical trial
* able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire

Exclusion Criteria

* documented nodal or distant metastases
* previous pelvic radiotherapy
* previous trans-urethral resection of prostate, previous prostatectomy or Highly Focused Ultrasound (HIFU)
* use of androgen deprivation therapy. Use of 5-alpha reductase inhibitors is permitted
* poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
* significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No