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High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy

This study is currently recruiting participants.
Study NCT00604526.   Last updated on July 21, 2008.   Information provided by Memorial Sloan-Kettering Cancer Center

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Descriptive Information Fields
Brief Title  High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
Official Title  Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
Brief Summary

High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR brachytherapy gives precise radiation to the prostate with less radiation given to the normal tissues near the prostate. For patients who have been treated with external beam radiation to the prostate before, HDR brachytherapy can give radiation again to the prostate without exposing the normal tissues around the prostate to significantly more radiation. This may be safer than giving external beam radiation again. The purpose of this study is to test the safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back after external beam radiation. We want to find out what effects, good and/or bad, the treatment has on you and your recurrent prostate cancer.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  assess feasibility & toxicity of HDR as salvage ther for local recurrent prostate cancer after ext beam radiotherapy. QOL instruments and questionnaires including the MSK prostate QOL instrument, the IIEF, IPSS , & the NCI CTC is used to assess toxicity. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  To assess biochemical or PSA relapse free survival. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Condition  Prostate Cancer
Intervention  Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds
MEDLINE PMIDs
Links Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  September 2006
Completion Date September 2010
Eligibility Criteria 

Inclusion Criteria:

  • KPS > than or equal to 80
  • Able to give informed consent
  • Able to complete toxicity scales and questionnaires
  • Histologically MSKCC confirmed diagnosis of recurrent prostate cancer.
  • Documented history of definitive radiotherapy to the prostate gland
  • IPSS of < than or equal to 15 at the time of evaluation
  • PSA < than or equal to 15 ng/ml
  • Organ confined disease

Exclusion Criteria:

  • Unable to tolerate general anesthesia
  • Abnormal complete blood count. Any of the following:
  • Platelet count less than 75,000/ml
  • Hb level less than 10 gm/dl
  • WBC less than 3.5/ml
  • Abnormal coagulation profile:
  • INR > 2.5
  • Abnormal Liver function tests (>1.5 x normal value)
  • Abnormal renal function tests (creatinine > 1.5)
  • Evidence of metastatic disease (bone scan, radiographs, MRI findings)
  • Prostate volume > 50 cc
  • Unable to meet treatment planning criteria
  • History of rectal surgery
  • External beam radiation dose to the prostate > 86.4 Gy if standard treatment planning dose constraints were met
  • History of inflammatory bowel disease
  • Expected survival < 1 year
  • Unable to undergo bone scan, CT or MRI evaluation
  • Unavailable for regular follow up
Gender Male
Ages 18 Years to 85 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Yoshiya Yamada, MD         yamadaj@mskcc.org    
Contact: Michael Zelefsky, MD         zelefskm@mskcc.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00604526
Organization ID 06-122
Secondary IDs ††
Study Sponsor  Memorial Sloan-Kettering Cancer Center
Collaborators ††
Investigators 
Principal Investigator:     Yoshiya Yamada, MD     Memorial Sloan-Kettering Cancer Center    
Information Provided By Memorial Sloan-Kettering Cancer Center
Verification Date July 2008
First Received Date  January 8, 2008
Last Updated Date July 21, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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