High-Dose Stereotactic Radiation for Prostate Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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
Absolute neutrophil count >= 1.5 k/uL
Platelet count >= 100 k/uL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x institutional upper limit of normal
Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
Serum creatinine < 3.0 mg/dL
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

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

National Cancer Institute (NCI)

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:	February 22, 2013
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Prostatic Neoplasms
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013