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

Prostate Cancer Clinical Trial

— pHART8  

Official title:

Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01505075
• Other study ID #: 043-2011
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2011
• Est. completion date: September 2021

Study information

• Verified date: November 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated radiation
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days

Locations

Country	Name	City	State
Canada	Odette Cancer Centre, Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade 3+ rectal toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Acute period (up to 3 months)
Secondary	Incidence of grade 3+ urinary toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Acute (up to 3 months) and Late (after 6 months of follow-up)
Secondary	Quality of Life	Expanded Prostate Cancer Index Composite (EPIC)	5 years
Secondary	Biochemical (ie.prostate specific antigen) disease free survival		5 years
Secondary	Incidence of grade 3+ rectal toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Late (after 6 months of follow-up)