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Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer

Primary Purpose

Adenocarcinoma of the Prostate, Stage III Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stereotactic body radiation therapy
quality-of-life assessment
laboratory biomarker analysis
androgen deprivation therapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed primary non-metastatic adenocarcinoma of the prostate

  • Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:

    • Pre-biopsy prostate-specific antigen (PSA) >= 20
    • Biopsy Gleason score 8-10
    • Clinical stage T3
  • No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings)

  • No distant metastases, based upon:

    • CT scan or MRI of the pelvis within 120 days prior to registration
    • Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
  • Karnofsky performance status (KPS) >= 70
  • Ability to understand, and willingness to sign, the written informed consent
  • Patient will have opted for SBRT among definitive treatment choices

Exclusion Criteria:

  • Patients with any evidence of distant metastases
  • Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
  • Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
  • Prior pelvic radiotherapy
  • History of Crohn’s disease or Ulcerative colitis

Sites / Locations

  • Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SBRT)

Arm Description

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

Outcomes

Primary Outcome Measures

Biochemical progression free survival
Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.
Biochemical progression free survival
Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.
Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4
Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire

Secondary Outcome Measures

Full Information

First Posted
November 13, 2014
Last Updated
March 10, 2023
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02296229
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer
Official Title
Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 27, 2014 (Actual)
Primary Completion Date
January 27, 2024 (Anticipated)
Study Completion Date
January 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials. II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer. III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer. OUTLINE: Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician. After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Stage III Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (SBRT)
Arm Type
Experimental
Arm Description
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy
Other Intervention Name(s)
SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Intervention Description
Undergo SBRT
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
androgen deprivation therapy
Other Intervention Name(s)
androgen suppression therapy
Intervention Description
up to 9 months at the discretion of the treating physician
Primary Outcome Measure Information:
Title
Biochemical progression free survival
Description
Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.
Time Frame
At 3 years
Title
Biochemical progression free survival
Description
Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.
Time Frame
At 5 years
Title
Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time Frame
At 4 months
Title
Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4
Time Frame
Up to 5 years
Title
Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire
Time Frame
Baseline to up to 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed primary non-metastatic adenocarcinoma of the prostate Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors: Pre-biopsy prostate-specific antigen (PSA) >= 20 Biopsy Gleason score 8-10 Clinical stage T3 No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings) No distant metastases, based upon: CT scan or MRI of the pelvis within 120 days prior to registration Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis Karnofsky performance status (KPS) >= 70 Ability to understand, and willingness to sign, the written informed consent Patient will have opted for SBRT among definitive treatment choices Exclusion Criteria: Patients with any evidence of distant metastases Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate Prior pelvic radiotherapy History of Crohn’s disease or Ulcerative colitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amar Kishan
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer

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