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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Sunnybrook Health Sciences Centre

ClinicalTrials.gov Identifier:

NCT01505075

First received: October 5, 2011

Last updated: April 26, 2017

Last verified: April 2017

History of Changes

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:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	October 5, 2011
Last Updated:	April 26, 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

ClinicalTrials.gov processed this record on September 21, 2017

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