Status:
ACTIVE_NOT_RECRUITING
Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Adenocarcinoma of the Prostate
Stage III Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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. Stereotacti...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 27 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT02296229
Start Date
January 27 2014
End Date
January 27 2027
Last Update
February 24 2025
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095