Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2019-04-05

Brief Summary

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The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.

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Detailed Description

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External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.

Conditions

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Prostatic Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Radiotherapy: phase 1/2 (but no drug, biological/vaccine or combination product used)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stereotactic Body Radiation Therapy

Group Type EXPERIMENTAL

Radiation Therapy

Intervention Type RADIATION

Stereotactic Body Radiation Therapy

Interventions

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Radiation Therapy

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.

Exclusion Criteria

* Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No