Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:

Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Intermediate Risk Adenocarcinoma of the Prostate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01737151
• Other study ID #: MCC-14712
• Secondary ID: NCI-2012-02545
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2013
• Est. completion date: November 9, 2017

Study information

• Verified date: August 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Description:

PRIMARY OBJECTIVES:

I. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.

SECONDARY OBJECTIVES:

I. To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.

II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria).

III. To determine the protocol completion rate. IV. To describe patient-reported outcomes using International Index of Erectile Function (IIEF) and EPIC Urinary and Bowel Assessment questionnaires.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard daily fractions of stereotactic body radiation therapy (SBRT) over 7-8.5 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: November 9, 2017
• Est. primary completion date: November 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:

• Low-risk disease - Histopathology score (Gleason sum): =<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: <10

• Intermediate-risk disease as either:

• Histopathology score (Gleason sum) =< 6, T-stage (per current American Joint Committee on Cancer [AJCC] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) > 10 but =< 20; or

• Histopathology score (Gleason sum) 7 with =< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA < 10

• Charlson index of comorbidity score =< 4

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease

• Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment

• Patients with a history of pelvic irradiation for any reason

• Life expectancy < 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two

• Prior radiation therapy, brachytherapy, or cryotherapy

• Prior surgical procedure involving peri-rectal and peri-prostatic area

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Stage I Prostate Cancer

Intervention

Radiation:
• stereotactic body radiation therapy
Undergo SBRT
• four fraction split-course SBRT
four fraction split-course SBRT

Locations

Country	Name	City	State
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria	Will be tested using a continuity corrected chi-square test	2 years
Secondary	Biochemical failure as defined by the Phoenix definition		Up to 5 years
Secondary	Protocol completion rate	The portion of patients completing the planned protocol with no unacceptable protocol violations is anticipated to be greater than 90%. A completion rate of 70% is deemed unacceptably low.	Up to 5 years
Secondary	Patient-reported outcomes	International Index of Erectile Function (IIEF) and Expanded Prostate Cancer Index Composite urinary Assessment (EPIC) urinary and bowel assessments will be used to collect patient-reported outcomes.; IIEF is a widely used instrument for the evaluation of male sexual function. It is has been recommended as tool for clinical trials of erectile dysfunction and for diagnostic evaluation of erectile dysfunction severity. 15 questions 1=very low (worst) to 5=very high (best).; The EPIC urinary and bowel assessments are comprehensive instruments designed to evaluate urinary and bowel symptoms, thereby providing a unique tool for assessment of quality of life issues important in prostate cancer management. 9 questions 0=no problem to 5=big problem	Up to 5 years
Secondary	Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria		Up to 90 days