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Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01859689
Collaborator
(none)
0
Enrollment
1
Arm
18
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: brachytherapy
  • Radiation: image-guided radiation therapy
  • Other: laboratory biomarker analysis
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

  1. 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.

  2. 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.

  3. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (image-guided HDR brachytherapy)

Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.

Radiation: brachytherapy
Undergo image-guided HDR brachytherapy
Other Names:
  • low-LET implant therapy
  • radiation brachytherapy
  • therapy, low-LET implant

    • Radiation: image-guided radiation therapy
    Undergo image-guided HDR brachytherapy

    Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Biochemical PSA control using the Phoenix definition of PSA nadir + 2 [5 years]

    Secondary Outcome Measures

    1. Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0 [3 months]

    2. Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0 [6 months]

    3. Changes in health related quality of life (HR-QOL) as determined by EPIC scores [Up to 24 months]

    4. Changes in HR-QOL as determined by IIEF scores [Up to 24 months]

    5. Changes in HR-QOL as determined by IPSS scores [Up to 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Mitchell Kamrava, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01859689
    Other Study ID Numbers:
    • 11-003235
    • NCI-2013-00647
    First Posted:
    May 22, 2013
    Last Update Posted:
    Jul 27, 2020
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jul 27, 2020