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

Prostate Cancer Clinical Trial

— PHART6  

Official title:

Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146340
• Other study ID #: 042-2010
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2010
• Est. completion date: April 2016

Study information

• Verified date: October 2019
• 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 (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated radiotherapy
40 Gy / 5 fractions / 29 days

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Association of Radiation Oncology

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 (<3 months)
Secondary	Incidence of grade 3+ urinary toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Acute (<3 months) and Late (>6 months)
Secondary	Quality of Life	Expanded Prostate Cancer Index Composite (EPIC)	5 years
Secondary	Biochemical (ie. prostate specific antigen) disease free survival		5 year
Secondary	Incidence of grade 3+ rectal toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Late (>6 months)