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

Sunnybrook Health Sciences Centre

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01505075

043-2011

Details and patient eligibility

About

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).

Full 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

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hypofractionated radiation

Experimental group

Description:

40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles

Treatment:

Radiation: Hypofractionated radiation