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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296229
Recruitment Status : Recruiting
First Posted : November 20, 2014
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Stage III Prostate Cancer Radiation: stereotactic body radiation therapy Other: quality-of-life assessment Other: laboratory biomarker analysis Drug: androgen deprivation therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer
Actual Study Start Date : January 27, 2014
Estimated Primary Completion Date : January 27, 2021
Estimated Study Completion Date : January 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Treatment (SBRT)
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.
Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: laboratory biomarker analysis
Correlative studies

Drug: androgen deprivation therapy
up to 9 months at the discretion of the treating physician
Other Name: androgen suppression therapy




Primary Outcome Measures :
  1. Biochemical progression free survival [ Time Frame: At 3 years ]
    Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.

  2. Biochemical progression free survival [ Time Frame: At 5 years ]
    Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.

  3. 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 ]
  4. Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4 [ Time Frame: Up to 5 years ]
  5. Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire [ Time Frame: Baseline to up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296229


Contacts
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Contact: Vincent Basehart 310-267-8954 vbasehart@mednet.ucla.edu

Locations
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United States, California
Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Vincent Basehart, M.D.    310-267-8954    vbasehart@mednet.ucla.edu   
Principal Investigator: Amar Kishan, M.D.         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Amar Kishan Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02296229    
Other Study ID Numbers: 13-001427
NCI-2014-02183 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
JCCCID410 ( Other Identifier: Jonsson Comprehensive Cancer Center )
13-001427 ( Other Identifier: Jonsson Comprehensive Cancer Center )
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs