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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Study Start Date :	September 2011
Actual Primary Completion Date :	January 2013
Estimated Study Completion Date :	January 2018

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, 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT01505075 History of Changes
Other Study ID Numbers:	043-2011
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