Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
Primary Purpose
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
brachytherapy
image-guided radiation therapy
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- Unilateral prostate cancer as determined by prostate biopsy
- Less than or equal to 3 positive biopsy cores
- No biopsy core >= 50% positive for cancer
- Karnofsky performance status (KPS) >= 70
- At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
- Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
- Clinical stage T1c or T2a
- PSA < 10 ng/ml
- Gleason score 3+3=6
Exclusion Criteria:
- Patients who have previously received radiation therapy to the pelvis
- Refusal to sign the informed consent
- Patients who are participating in a concurrent treatment protocol
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (image-guided HDR brachytherapy)
Arm Description
Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
Outcomes
Primary Outcome Measures
Biochemical PSA control using the Phoenix definition of PSA nadir + 2
Secondary Outcome Measures
Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0
Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0
Changes in health related quality of life (HR-QOL) as determined by EPIC scores
Changes in HR-QOL as determined by IIEF scores
Changes in HR-QOL as determined by IPSS scores
Full Information
NCT ID
NCT01859689
First Posted
April 4, 2013
Last Updated
July 23, 2020
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01859689
Brief Title
Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
Official Title
A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.
SECONDARY OBJECTIVES:
I. To assess acute and late toxicity outcomes following targeted brachytherapy according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
II. To determine changes from baseline in health-related quality of life indicators using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score (IPSS) questionnaire.
III. To assess the potential value of multiparametric magnetic resonance imaging, including dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular tactographic imaging in predicting the development of equivocal disease (ED) following radiation treatment.
OUTLINE:
Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (image-guided HDR brachytherapy)
Arm Type
Experimental
Arm Description
Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Other Intervention Name(s)
low-LET implant therapy, radiation brachytherapy, therapy, low-LET implant
Intervention Description
Undergo image-guided HDR brachytherapy
Intervention Type
Radiation
Intervention Name(s)
image-guided radiation therapy
Intervention Description
Undergo image-guided HDR brachytherapy
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Biochemical PSA control using the Phoenix definition of PSA nadir + 2
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0
Time Frame
3 months
Title
Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0
Time Frame
6 months
Title
Changes in health related quality of life (HR-QOL) as determined by EPIC scores
Time Frame
Up to 24 months
Title
Changes in HR-QOL as determined by IIEF scores
Time Frame
Up to 24 months
Title
Changes in HR-QOL as determined by IPSS scores
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
Unilateral prostate cancer as determined by prostate biopsy
Less than or equal to 3 positive biopsy cores
No biopsy core >= 50% positive for cancer
Karnofsky performance status (KPS) >= 70
At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
Clinical stage T1c or T2a
PSA < 10 ng/ml
Gleason score 3+3=6
Exclusion Criteria:
Patients who have previously received radiation therapy to the pelvis
Refusal to sign the informed consent
Patients who are participating in a concurrent treatment protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Kamrava
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
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