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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604526
First Posted: January 30, 2008
Last Update Posted: January 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To assess biochemical or PSA relapse free survival. [ Time Frame: conclusion of study ]

Enrollment: 42
Study Start Date: September 2006
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Questionnaires, Iridium 192 radioactive seeds
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604526


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Yoshiya Yamada, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00604526     History of Changes
Other Study ID Numbers: 06-122
First Submitted: January 8, 2008
First Posted: January 30, 2008
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases