High-Dose Stereotactic Radiation for Prostate Cancer

Adenocarcinoma of the Prostate Clinical Trial

Official title:

High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664130
• Other study ID #: CASE1812
• Secondary ID: NCI-2012-01252
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: January 12, 2017

Study information

• Verified date: May 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 12, 2017
• Est. primary completion date: January 12, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer

Intervention

Radiation:
• stereotactic body radiation therapy
Undergo SBRT

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	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	1.5 months
Primary	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	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	4 months
Primary	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	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	8 months
Primary	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	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	12 months
Secondary	Quality of Life as Assessed by EPIC Scores	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.	Baseline and 1.5 months
Secondary	Quality of Life as Assessed by EPIC Scores	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.	Baseline and 4 months
Secondary	Quality of Life as Assessed by EPIC Scores	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.	Baseline and 8 months
Secondary	Quality of Life as Assessed by EPIC Scores	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.	Baseline and 12 months
Secondary	Quality of Life as Assessed by Change in AUA Scores	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.	Baseline and 1.5 months
Secondary	Quality of Life as Assessed by Change in AUA Scores	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.	Baseline and 4 months
Secondary	Quality of Life as Assessed by Change in AUA Scores	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.	Baseline and 8 months
Secondary	Quality of Life as Assessed by Change in AUA Scores	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.	Baseline and 12 months
Secondary	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.	Baseline and 1.5 months
Secondary	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.	Baseline and 4 months
Secondary	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.	Baseline and 8 months
Secondary	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.	Baseline and 12 months