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

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00604526

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

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess biochemical or PSA relapse free survival. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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

Ages Eligible for Study:	18 Years to 85 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604526

Contacts

Contact: Yoshiya Yamada, MD		yamadaj@mskcc.org
Contact: Michael Zelefsky, MD		zelefskm@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Yoshiya Yamada, MD yamadaj@mskcc.org
Contact: Michael Zelefsky, MD zelefskm@mskcc.org
Principal Investigator: Yoshiya Yamada, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Yoshiya Yamada, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Yoshiya Yamada, MD )
Study ID Numbers:	06-122
Study First Received:	January 8, 2008
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00604526 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

recurrent

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009