High-Dose Stereotactic Radiation for Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01664130
First received: August 10, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Radiation: stereotactic body radiation therapy
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0 [ Time Frame: 1.5 months ] [ Designated as safety issue: Yes ]
    Excessive GI and GU toxicity will be defined as a grade 3 GU toxicity rate of ≥15%.

  • Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0 [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0 [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • Number of patients with treatment related GI and GU toxicity as assessed by the NCI CTCTAE version 4.0 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life as assessed by EPIC and AUA scores [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
  • Quality of life as assessed by EPIC and AUA scores [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Quality of life as assessed by EPIC and AUA scores [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Quality of life as assessed by EPIC and AUA scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Biochemical response as measured by serum PSA [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
    Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

  • Change in Biochemical response as measured by serum PSA [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

  • Change in Biochemical response as measured by serum PSA [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

  • Change in Biochemical response as measured by serum PSA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.


Estimated Enrollment: 38
Study Start Date: July 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (SBRT)
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.
Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664130

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kevin L. Stephans    216-445-8285    stephak@ccf.org   
Principal Investigator: Kevin L. Stephans         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Kevin Stephans Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01664130     History of Changes
Other Study ID Numbers: CASE1812, NCI-2012-01252
Study First Received: August 10, 2012
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 16, 2014