NCT01737151TerminatedNot Applicable
Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Intermediate Risk Adenocarcinoma of the Prostate
Virginia Commonwealth University3 sites in 1 country19 target enrollmentStarted: March 8, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 19
- Locations
- 3
- Primary Endpoint
- Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
Study Overview
Brief 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.
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm I (standard stereotactic body radiation therapy (SBRT)
Active Comparator
Patients undergo standard daily fractions of SBRT over 7-8.5 weeks
Intervention: stereotactic body radiation therapy (Radiation)
Arm II (four fraction split-course SBRT)
Experimental
Patients undergo 2 fractions of SBRT in weeks 1 and 4
Intervention: four fraction split-course SBRT (Radiation)
Outcomes
Primary Outcomes
Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
Time Frame: 2 years
Will be tested using a continuity corrected chi-square test
Secondary Outcomes
- Biochemical failure as defined by the Phoenix definition(Up to 5 years)
- Protocol completion rate(Up to 5 years)
- Patient-reported outcomes(Up to 5 years)
- Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria(Up to 90 days)
Investigators
Study Sites (3)
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