High-Dose Stereotactic Radiation for Prostate Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage III Prostate Cancer; Adenocarcinoma of the Prostate; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Radiation: stereotactic body radiation therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: laboratory biomarker analysis; Correlative studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Radiation: stereotactic body radiation therapy; Undergo SBRT; Other Names: SBRT; stereotactic radiation therapy; stereotactic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kevin Stephans, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Publications and helpful links

General Publications

• Parsai S, Juloori A, Sedor G, Reddy CA, Thousand R, Magnelli A, Berglund RK, Stovsky M, Klein EA, Tendulkar RD, Stephans KL. Heterogenous Dose-escalated Prostate Stereotactic Body Radiation Therapy for All Risk Prostate Cancer: Quality of Life and Clinical Outcomes of an Institutional Pilot Study. Am J Clin Oncol. 2020 Jul;43(7):469-476. doi: 10.1097/COC.0000000000000693.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): January 12, 2017
• Study Completion (Actual): January 12, 2017

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 14, 2012

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CASE1812; NCI-2012-01252 (Registry Identifier: CTRP (Clinical Trial Reporting Program))