High-Dose Stereotactic Radiation for Prostate Cancer

Completed · Not applicable

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

In brief

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

Key facts

Study ID

NCT01664130

Run by

Case Comprehensive Cancer Center

People needed

35

Starts

2012-07-01

Expected to finish

2017-01-12

Last updated by the study team

2020-05-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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