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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01505075
First Posted: January 6, 2012
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
  Purpose
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).

Condition Intervention Phase
Prostate Cancer Radiation: Hypofractionated radiation Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

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


Secondary Outcome Measures:
  • 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

  • Quality of Life [ Time Frame: 5 years ]
    Expanded Prostate Cancer Index Composite (EPIC)

  • Biochemical (ie.prostate specific antigen) disease free survival [ Time Frame: 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


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: RapidArc

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505075


Locations
Canada, Ontario
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Andrew Loblaw, MD, FRCPC Sunnybrook Health Sciences Centre
Principal Investigator: Suneil Jain, MD suneil.jain@sunnybrook.ca
  More Information

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01505075     History of Changes
Other Study ID Numbers: 043-2011
First Submitted: October 5, 2011
First Posted: January 6, 2012
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Sunnybrook Health Sciences Centre:
prostatic neoplasms
radiotherapy
hypofractionated
high risk prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs