High-Dose Stereotactic Radiation for Prostate Cancer

Not Applicable

Completed

Conditions: Stage I Prostate Cancer
Stage IIB Prostate Cancer
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IIA Prostate Cancer
Stage III Prostate Cancer

Interventions: Radiation: stereotactic body radiation therapy
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis

Brief 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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment (SBRT)	stereotactic body radiation therapy	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.
Treatment (SBRT)	quality-of-life assessment	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.
Treatment (SBRT)	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	1.5 months	Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	12 months	Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	Baseline and 12 months	Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
Quality of Life as Assessed by EPIC Scores	Baseline and 12 months	Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Quality of Life as Assessed by Change in AUA Scores	Baseline and 12 months	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.