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Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01354951
Recruitment Status : Terminated (Lack of accrual)
First Posted : May 17, 2011
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
University of Colorado, Denver
M.D. Anderson Cancer Center
Northwell Health
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the investigators would like to see how this type of treatment impacts quality of life.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
Study Start Date : May 2011
Actual Primary Completion Date : October 6, 2017
Actual Study Completion Date : October 6, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
 Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions. Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment. The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125). The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.


Outcome Measures
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Primary Outcome Measures :
  1. To Assess the Late Toxicity Outcomes [ Time Frame: 6 months to 2 years ]
    focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0


Secondary Outcome Measures :
  1. To Evaluate the Local Tumor Control After Focal Brachytherapy [ Time Frame: 12 and 24 months ]
    as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered. "All negative" means no prostate cancer;

  2. To Evaluate the Change From Baseline in QOL Indicators [ Time Frame: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment ]
    Following focal brachytherapy in patients with early stage low volume localized prostate cancer. The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ

  3. To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes [ Time Frame: 2 years ]
    Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined. Post-treatment biopsy outcome is defined as a binary variable: positive and negative. We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy. The correlation will be assessed by a Fisher exact test.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
  • Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Prostate cancer clinical stage T1c-T2a
  • PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
  • MRI evidence of one-sided disease performed within 3 months of registration
  • Prostate size <60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters:
  • Minimum of 10 biopsy cores
  • Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
  • Unilateral cancer (only right-sided or left-sided, not bilateral)
  • No more than 50 % cancer in any one biopsy core
  • No more than 25 % of cores containing cancer
  • Repeat transrectal or transperineal prostate biopsy that must meet the following parameters:
  • Minimum of 12 biopsy cores
  • Unilateral cancer (only right-sided or left-sided, not bilateral)
  • Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
  • No more than 50 % cancer in any one biopsy core
  • No more than 25 % of cores containing cancer

Subject Exclusion Criteria:

  • Medically unfit for anesthesia
  • Evidence or suspicion of extracapsular extension on MRI
  • IPSS score > 18
  • Unable to receive MRI
  • Prior radiotherapy for the current disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354951


Locations
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United States, New York
North Shore LIJ
New Hyde Park, New York, United States, 11040
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
Md Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Colorado, Denver
M.D. Anderson Cancer Center
Northwell Health
Investigators
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Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] November 6, 2012

More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01354951    
Other Study ID Numbers: 11-056
First Posted: May 17, 2011    Key Record Dates
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018
Last Verified: November 2017
Keywords provided by Memorial Sloan Kettering Cancer Center:
Focal Brachytherapy
Endorectal coil MRI
Quality of Life
11-056
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases