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

NCT01890096 | Unknown Phase 2

• 1 other identifier: GMOR_HDR Monotherapy RCT
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma of the Prostate

Keywords

HDR; monotherapy; low; intermediate; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Health related quality of life (QoL)

  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.

  1 year

Secondary Outcomes (6)

• GU and GI toxicities

  baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years

• Urinary Symptoms

  baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years

• Serum PSA changes

  baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years

• Biochemical failure and disease free survival rates

  5 years

• Erectile function

  5 year

Study Arms (2)

HDR 2 fractions

EXPERIMENTAL

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

Radiation: HDR 2 Fraction

HDR 1 fraction

EXPERIMENTAL

HDR brachytherapy of 19 Gy delivered in a single fraction

Radiation: HDR 1 Fraction

Interventions

HDR 2 Fraction 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 2 fractions

HDR 1 Fraction 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

HDR 1 fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gerard Morton, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gerard Morton

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 1, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2020
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CA (1)