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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00604526
First received: January 8, 2008
Last updated: January 31, 2014
Last verified: January 2014

January 8, 2008
January 31, 2014
September 2006
September 2014   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00604526 on ClinicalTrials.gov Archive Site
To assess biochemical or PSA relapse free survival. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds

Pre-tx Sexual function questionnaire Quality of Life baseline, Treatment with HDR (Two days) Treatment: Iridium 192 radioactive seeds temporarily inserted into patient. Post treatment (after HDR) Month 1 (+/- 2 weeks), 3 (+/- 1 month), 6 (+/- 1 month), 9 (+/-1 month), 12 (+/- 1 month)* NCI CTC GU and GI assessment,IPSS, IIEF, PSA lab test, Prostate HRQOL

*After 1 year, will follow up with doctor about every 6 months.

Experimental: 1
Questionnaires, Iridium 192 radioactive seeds
Intervention: Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Male
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00604526
06-122
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Yoshiya Yamada, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP