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

NCT01354951 | Terminated Phase 2 Results

• 1 other identifier: 11-056
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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

Keywords

Focal Brachytherapy; Endorectal coil MRI; Quality of Life; 11-056

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To Evaluate the Local Tumor Control After Focal Brachytherapy

  12 and 24 months

• To Evaluate the Change From Baseline in QOL Indicators

  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

  2 years

Study Arms (1)

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

EXPERIMENTAL

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

Interventions

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL 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.

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Colorado, Denver: collaborator
• M.D. Anderson Cancer Center: collaborator
• Northwell Health: collaborator

Study Sites (3)

North Shore LIJ

New Hyde Park, New York, 11040, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Michael Zelefsky, MD
• Organization: Memorial Sloan Kettering Cancer Center

zelefskm@mskcc.org

212-639-6802

Study Officials

• Michael Zelefsky, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 17, 2011
• Study Start: May 1, 2011
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2017-11

Locations

US (3)