Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer (pHART8)

November 23, 2020 updated by: Sunnybrook Health Sciences Centre

Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary Endpoints:

  • Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities

Secondary Endpoints:

  • Late GI and GU Radiation Therapy Oncology Group (RTOG) toxicities
  • Biochemical disease-free survival
  • Biopsy positive rate at 3 years
  • Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
  • Develop a biobank of DNA and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity

Study Type

Interventional

Enrollment (Anticipated)

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
        • Odette Cancer Centre, 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:

  • informed consent obtained
  • men > 18 years
  • histologically confirmed prostate adenocarcinoma (centrally reviewed)
  • high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA > 20ng/mL

Exclusion Criteria:

  • prior pelvic radiotherapy
  • anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • diagnosis of bleeding diathesis
  • pelvic girth > 40cm (to ensure visibility of gold seeds on electronic portal imaging)
  • large prostate (> 90cm3) on imaging
  • severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia > 3)
  • No evidence of castrate resistance (defined as PSA < 3ng/mL while testosterone is < 0.7nmol/L). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression

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: Hypofractionated radiation
40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles
Radiation: Hypofractionated radiation
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
Other Names:
  • RapidArc

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Andrew Loblaw, MD, FRCPC, Sunnybrook Health Sciences Centre
  • Principal Investigator: Suneil Jain, MD, suneil.jain@sunnybrook.ca

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 (Actual)

September 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

October 5, 2011

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 043-2011

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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