Back to resultsStereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
Primary Purpose
Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Stereotactic Body Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7
Eligibility Criteria
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
Sites / Locations
- UCLA / Jonsson Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (SBRT)
Arm Description
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
Outcomes
Primary Outcome Measures
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
Secondary Outcome Measures
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
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).
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
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.
Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.
The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.
Full Information
NCT ID
NCT02830165
First Posted
July 7, 2016
Last Updated
December 7, 2021
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02830165
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
Official Title
Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
May 9, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (SBRT)
Arm Type
Experimental
Arm Description
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
Time Frame
At 4 weeks post surgery
Secondary Outcome Measure Information:
Title
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Description
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).
Time Frame
Up to 1 year
Title
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
Description
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.
Time Frame
score from baseline to twelve months
Title
Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.
Description
The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.
Time Frame
Mean change in I-PSS score from baseline to 12 months.
Other Pre-specified Outcome Measures:
Title
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
Description
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
Time Frame
Baseline and to up to 1 year
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Nickols, MD, PhD
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / 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 High-Risk Prostate Cancer Undergoing Surgery
We'll reach out to this number within 24 hrs