- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02830165
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.
SECONDARY OBJECTIVES:
I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite [EPIC] and International Prostate Symptom Score [IPSS] questionnaires).
II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.
III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT.
OUTLINE:
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- Patient desires and is medically fit to undergo prostatectomy
- Karnofsky performance status (KPS) >= 70
- Patients on androgen deprivation therapy (ADT) are allowed
For confirmation of high risk local failure status, patients will have any one of the following:
- Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study
- Pre-biopsy prostate-specific antigen (PSA) >= 20
- Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy
- Gleason score 7 and > 50% of biopsy cores positive for prostate cancer
- Clinical stage >= T3 (staging by imaging acceptable)
- An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy
Exclusion Criteria:
Distant metastases, based upon:
- CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and
- Bone scan or PSMA PET/CT 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 prior to registration
- Patient is unable or unwilling to sign consent
- Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (SBRT)
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
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Correlative studies
Ancillary studies
Other Names:
Undergo SBRT
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
Time Frame: At 4 weeks post surgery
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At 4 weeks post surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Time Frame: Up to 1 year
|
Based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.
Grade refers to the severity of the adverse event.
Indications are Grade 1 is Mild, Grade 2 is Moderate, Grade 3 is Severe or medically significant but not immediately life threatening.
Grade 0 refers to absence of an adverse event (ae).
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Up to 1 year
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Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
Time Frame: score from baseline to twelve months
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The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) is composed of 26 items and measures health-related quality of life across 5 prostate cancer domains.
Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing a better quality of life.
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score from baseline to twelve months
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Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.
Time Frame: Mean change in I-PSS score from baseline to 12 months.
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The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.
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Mean change in I-PSS score from baseline to 12 months.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
Time Frame: Baseline and to up to 1 year
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Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT
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Baseline and to up to 1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicholas Nickols, MD, PhD, UCLA / Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-001580
- P50CA092131 (U.S. NIH Grant/Contract)
- NCI-2016-00188 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- JCCCID608
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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