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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • North Shore LIJ
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	12 and 24 months
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	baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
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.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: M.D. Anderson Cancer Center; University of Colorado, Denver; Northwell Health

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 6, 2017
• Study Completion (Actual): October 6, 2017

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Quality of Life; Focal Brachytherapy; Endorectal coil MRI; 11-056
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 11-056