This trial is active, not recruiting.

Conditions prostate adenocarcinoma, stage i prostate cancer
Treatments stereotactic body radiation therapy, four fraction split-course sbrt
Phase phase 2
Sponsor Virginia Commonwealth University
Start date March 2013
End date July 2017
Trial size 19 participants
Trial identifier NCT01737151, MCC-14712, NCI-2012-02545


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Patients undergo standard daily fractions of SBRT over 7-8.5 weeks
stereotactic body radiation therapy SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Undergo SBRT
Patients undergo 2 fractions of SBRT in weeks 1 and 4
four fraction split-course sbrt
four fraction split-course SBRT

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

Secondary Outcomes

Biochemical failure as defined by the Phoenix definition
time frame: Up to 5 years
Protocol completion rate
time frame: Up to 5 years
Patient-reported outcomes
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Mitchell Anscher, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.