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

Phase 2

• Conditions: Carcinoma of the Prostate
• Interventions: Radiation: HDR 2 Fraction; Radiation: HDR 1 Fraction

• Registration Number: NCT01890096
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-01
• Primary Completion: 2017-05-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HDR 2 fractions	HDR 2 Fraction	HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart
HDR 1 fraction	HDR 1 Fraction	HDR brachytherapy of 19 Gy delivered in a single fraction

Primary Outcome Measures

Name	Time	Method
Health related quality of life (QoL)	1 year	To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Biochemical failure and disease free survival rates	5 years	To determine PSA failure and disease free survival rates in both study arms
Urinary Symptoms	baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years	To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS)
Erectile function	5 year	To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale
GU and GI toxicities	baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years	To determine genito-urinary (GU) and gastro-intestinal (GI) toxicities in both study arms according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Serum PSA changes	baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years	To determine changes in serum prostate-specific antigen (PSA) in both arms
Associations between dosimetric parameters and toxicity/EPIC domains	5 years	To explore association between dosimetric parameters and toxicity/EPIC domain change

Trial Locations

Locations (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada