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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Focal Brachytherapy, Endorectal coil MRI, Quality of Life, 11-056

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • North Shore LIJ
  • Memorial Sloan Kettering Cancer Center
  • Md Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

Arm Description

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.

Outcomes

Primary Outcome Measures

To Assess the Late Toxicity Outcomes
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

To Evaluate the Local Tumor Control After Focal Brachytherapy
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;
To Evaluate the Change From Baseline in QOL Indicators
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
To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes
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.

Full Information

First Posted
May 16, 2011
Last Updated
March 19, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Colorado, Denver, M.D. Anderson Cancer Center, Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT01354951
Brief Title
Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
Official Title
Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 6, 2017 (Actual)
Study Completion Date
October 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Colorado, Denver, M.D. Anderson Cancer Center, Northwell Health

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Focal Brachytherapy, Endorectal coil MRI, Quality of Life, 11-056

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Intervention Description
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.
Primary Outcome Measure Information:
Title
To Assess the Late Toxicity Outcomes
Description
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
Time Frame
6 months to 2 years
Secondary Outcome Measure Information:
Title
To Evaluate the Local Tumor Control After Focal Brachytherapy
Description
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;
Time Frame
12 and 24 months
Title
To Evaluate the Change From Baseline in QOL Indicators
Description
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
Time Frame
baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
Title
To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zelefsky, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore LIJ
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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

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