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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Withdrawn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
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 4, 2013
    Last Updated
    July 23, 2020
    Sponsor
    Jonsson Comprehensive Cancer Center
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    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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