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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of grade 3+ rectal toxicity

Outcome Description:

Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Outcome Time Frame:

Acute period (up to 3 months)

Safety Issue:

Yes

Principal Investigator

Andrew Loblaw, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre

Authority:

Canada: Ethics Review Committee

Study ID:

043-2011

NCT ID:

NCT01505075

Start Date:

September 2011

Completion Date:

September 2016

Related Keywords:

  • Prostate Cancer
  • prostatic neoplasms
  • radiotherapy
  • hypofractionated
  • high risk prostate cancer
  • Prostatic Neoplasms

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