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

NCT ID: NCT01354951

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-10-06

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Zelefsky, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

North Shore LIJ

New Hyde Park, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Md Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

11-056

Identifier Type: -

Identifier Source: org_study_id