Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: SBRT Prostate

• Registration Number: NCT00941915
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.

Detailed Description

This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Study Start: 2009-11-09
• Primary Completion: 2017-02
• Study Completion: 2020-07-17
• Results First Submitted: 2021-06-22
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-17
• Last Update Submitted: 2021-11-17
• Results First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment
• History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment
• Gleason score less than or equal to 7
• Clinical Stage T1-T2c
• PSA
• less than or = 15 ng/ml prior to start of therapy if Gleason < or = 6 or
• less than or = 10 ng/ml prior to start of therapy if Gleason = 7
• Zubrod Performance Status 0-1
• Age > 40

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Exclusion Criteria

• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible)
• Evidence of distant metastases
• Regional lymph node involvement
• Significant urinary obstruction
• Estimated prostate gland > 100 grams
• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
• Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
• Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy
• Previous or concurrent cytotoxic chemotherapy for prostate cancer
• Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
• Severe, active comorbidity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Radiotherapy	SBRT Prostate	Five fractions of 7.4 Gy each

Primary Outcome Measures

Name	Time	Method
Number of Participants With Genitourinary Acute Toxicity	</= 90 days post radiation treatment, a total of 90 days	Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
Number of Participants With Gastrointestinal Late Toxicity	>90 days from the end of treatment, up to 3 years	Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment
Number of Participants With Genitourinary Late Toxicity	>90 days from the end of treatment, up to 3 years	Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment
Number of Participants With Gastrointestinal Acute Toxicity	</= 90 days post radiation treatment, a total of 90 days	Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	5 yrs
Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form	3 years post-treatment	The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States