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

Tracking Information

First Received Date ^ICMJE

January 8, 2008

Last Updated Date

October 5, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00604526 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Experimental: Questionnaires, Iridium 192 radioactive seeds

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00604526

Responsible Party

Yoshiya Yamada, MD, Memorial Sloan-Kettering Cancer Center

Study ID Numbers ^ICMJE

06-122

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yoshiya Yamada, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

October 2009

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