Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer (PHART6)

October 2, 2019 updated by: Andrew Loblaw, Sunnybrook Health Sciences Centre

Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men >18 years
  • Histologically confirmed prostate adenocarcinoma
  • Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Presence of a hip prosthesis
  • Pelvic girth >40cm - Large prostate (>90cm3) on imaging
  • Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT
SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT
Radiation: Hypofractionated radiotherapy
40 Gy / 5 fractions / 29 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 3+ rectal toxicity
Time Frame: Acute period (<3 months)
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Acute period (<3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 3+ urinary toxicity
Time Frame: Acute (<3 months) and Late (>6 months)
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Acute (<3 months) and Late (>6 months)
Quality of Life
Time Frame: 5 years
Expanded Prostate Cancer Index Composite (EPIC)
5 years
Biochemical (ie. prostate specific antigen) disease free survival
Time Frame: 5 year
5 year
Incidence of grade 3+ rectal toxicity
Time Frame: Late (>6 months)
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Late (>6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Association of Radiation Oncology

Investigators

  • Principal Investigator: Harvey Quon, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 042-2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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