Overview

This trial is active, not recruiting.

Conditions adenocarcinoma of the prostate, recurrent prostate cancer, stage i prostate cancer, stage iia prostate cancer, stage iib prostate cancer, stage iii prostate cancer
Treatments stereotactic body radiation therapy, quality-of-life assessment, laboratory biomarker analysis
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date July 2012
End date December 2014
Trial size 35 participants
Trial identifier NCT01664130, CASE1812, NCI-2012-01252

Summary

This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT 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

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.
stereotactic body radiation therapy SBRT
Undergo SBRT
quality-of-life assessment quality of life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0
time frame: 1.5 months
Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0
time frame: 4 months
Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0
time frame: 8 months
Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0
time frame: 12 months

Secondary Outcomes

Measure
Quality of life as assessed by EPIC and AUA scores
time frame: 1.5 months
Quality of life as assessed by EPIC and AUA scores
time frame: 4 months
Quality of life as assessed by EPIC and AUA scores
time frame: 8 months
Quality of life as assessed by EPIC and AUA scores
time frame: 12 months
Change in Biochemical response as measured by serum PSA
time frame: 1.5 months
Change in Biochemical response as measured by serum PSA
time frame: 4 months
Change in Biochemical response as measured by serum PSA
time frame: 8 months
Change in Biochemical response as measured by serum PSA
time frame: 12 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - The patient must have prostate adenocarcinoma proven by histologic diagnosis - The patient must have clinical stage T1a-T3b with localized prostate cancer considered low, intermediate, or high risk as defined by the National Comprehensive Cancer Network (NCCN) guidelines; any patient whom is defined as high-risk must undergo screening with computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis as well as bone scan prior to enrollment for staging purposes; low and intermediate risk patients do not require imaging for staging unless they have a focal symptom warranting investigation - Performance status - Karnofsky performance status (PS) >= 70 - Life expectancy of > 5 years, in the opinion of and as documented by the investigator - Patients must either already have fiducials already placed within the prostate, or otherwise be candidates for prostate fiducial placement (no bleeding disorders which may cause excessive bleeding with fiducial placement, INR < 2.0). - Patients must have prostate-specific antigen (PSA) drawn within the 90 days prior to enrollment - Men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 12 months after completing treatment - Subjects must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Prior treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 - Patients who are receiving any other investigational agents - Evidence of metastatic disease prior to radiation - Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Prior pelvic radiation therapy - Patients whom are planned to receive pelvic nodal radiation are excluded - Weight > 350 lbs - Contraindications to placement of fiducials required for high-precision image guidance (e.g. bleeding disorders which may cause excessive bleeding with placement, requirement for coumadin, international normalized ratio [INR] > 2.0) - Patients unable to maintain a full bladder during treatment - Previous prostatectomy - Inflammatory bowel disease - AUA score > 15 in spite of optimal therapy

Additional Information

Official title High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer
Principal investigator Kevin Stephans
Description PRIMARY OBJECTIVES: I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SBRT for localized prostate cancer. SECONDARY OBJECTIVES: I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC) and American Urological Association (AUA) scores. II. Assess biochemical control after high-dose SBRT. OUTLINE: Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months, every 6 months for 4 years, and then annually thereafter.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.