Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer (PHART6)

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated radiotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01146340

042-2010

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men >18 years
• Histologically confirmed prostate adenocarcinoma
• Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL

Exclusion criteria

• Prior pelvic radiotherapy
• Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
• Diagnosis of bleeding diathesis
• Presence of a hip prosthesis
• Pelvic girth >40cm - Large prostate (>90cm3) on imaging
• Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)

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

SBRT

Experimental group

Description:

SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT

Treatment:

Radiation: Hypofractionated radiotherapy