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

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ClinicalTrials.gov Identifier: NCT01505075
Recruitment Status : Active, not recruiting
First Posted : January 6, 2012
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Radiation: Hypofractionated radiation Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Actual Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 Name: RapidArc


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

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

  3. Biochemical (ie.prostate specific antigen) disease free survival [ Time Frame: 5 years ]
  4. Incidence of grade 3+ rectal toxicity [ Time Frame: Late (after 6 months of follow-up) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Canada, Ontario
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Andrew Loblaw, MD, FRCPC Sunnybrook Health Sciences Centre
Principal Investigator: Suneil Jain, MD suneil.jain@sunnybrook.ca
More Information
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01505075     History of Changes
Other Study ID Numbers: 043-2011
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Keywords provided by Sunnybrook Health Sciences Centre:
prostatic neoplasms
radiotherapy
hypofractionated
high risk prostate cancer
Additional relevant MeSH terms:
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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