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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT

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

Group Type EXPERIMENTAL

Hypofractionated radiotherapy

Intervention Type RADIATION

40 Gy / 5 fractions / 29 days

Interventions

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Hypofractionated radiotherapy

40 Gy / 5 fractions / 29 days

Intervention Type RADIATION

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No