High-Dose Stereotactic Radiation for Prostate Cancer

NCT ID: NCT01664130

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-01-12

Brief 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

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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Undergo SBRT

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

stereotactic body radiation therapy

Undergo SBRT

Intervention Type: RADIATION

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

SBRT; stereotactic radiation therapy; stereotactic radiotherapy; quality of life assessment

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Stephans

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32349020 (View on PubMed)

Other Identifiers

NCI-2012-01252

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE1812

Identifier Type: -

Identifier Source: org_study_id