Advertisement

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

Sponsored by Memorial Sloan-Kettering Cancer Center

Phase Quota
Phase 2

The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating low-risk 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 Start Date: May 2011

Estimated Completion Date: May 2016

Specialties: Urology: Oncology,Prostate,Radiology/Diagnostics Oncology: Radiation Oncology,Renal/Urologic Radiology: Radiotherapy (XRT)

Interventions

  • Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

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

Study Locations And Contact Information

  • Md Anderson Cancer Center, Houston Texas
  • Md Anderson Cancer Center, Houston Texas
  • North Shore LIJ, New Hyde Park New York
  • Memorial Sloan Kettering Cancer Center, New York New York

Feature this Clinical Trial

Get your trial in front of 1000s of physicians and patients.
Visit ClinicalTrialsLocator.com to find out how you can feature this clinical trial.

Advertisement