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

This study is currently recruiting participants.
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
University of Colorado, Denver
M.D. Anderson Cancer Center
North Shore Long Island Jewish Health System
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01354951
First received: May 16, 2011
Last updated: February 13, 2014
Last verified: February 2014

May 16, 2011
February 13, 2014
May 2011
May 2015   (final data collection date for primary outcome measure)
To assess the late toxicity outcomes [ Time Frame: 6 months to 2 years ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01354951 on ClinicalTrials.gov Archive Site
  • To evaluate the local tumor control after focal brachytherapy [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
  • To evaluate the local tumor control after focal brachytherapy [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment ] [ Designated as safety issue: No ]
    Following focal brachytherapy in patients with low-risk 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 endorectal coil MRI (eMRI) findings with post-treatment biopsy outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
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.
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.
Intervention: Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Male
21 Years and older
No
Contact: Michael Zelefsky, MD 212-639-6802
Contact: Jonathan Coleman, MD 646-422-4432
United States
 
NCT01354951
11-056
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • University of Colorado, Denver
  • M.D. Anderson Cancer Center
  • North Shore Long Island Jewish Health System
Principal Investigator: Michael Zelefsky, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP