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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01146340

Acronym

PHART6

Enrollment

Registered

2010-06-17

Start date

2010-05-31

Completion date

2016-04-30

Last updated

2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostatic Neoplasms, Radiotherapy, Hypofractionation, Low and Intermediate Risk Prostate Cancer

Brief 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.

Interventions

RADIATIONHypofractionated radiotherapy

40 Gy / 5 fractions / 29 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Incidence of grade 3+ rectal toxicity	Acute period (<3 months)	Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026