Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data

This study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, December 2008

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center BIOSCIENCES CORPORATION NYU MEDICAL CENTER
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00578409

Purpose

We seek to improve the predictive accuracy of the nomogram to predict survival for patients with castrate mets disease through the addition of pathological data, the results of automated machine vision based image analysis of H&E stained tumor tissue developed at Aureon Biosciences,and molecular biomarker studies (25 markers) determined by immunohistochemistry on tissue microarrays prepared from paraffin-embedded tumor.

Condition
Prostate Cancer

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data

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

Primary Outcome Measures:

The analysis for the progressive castrate mets disease population consists of two analytical steps. The first step involved the development of a predictive model of pt survival using supervised multivariate analytical (SMA)techniques [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

In a first analytical step, using only the clinical and pathological variables used in the original clinical mets castrate disease nomogram as inputs, supervised multivariate analytical techniques (SMA) were used to generate a new predictive model for patient survival. A similar approach will then be used to analyze a second group of approximately 223 pts in the state of a rising PSA14 after surgery or radiation therapy treated on a sequential series of IRB approved trials testing conjugate vaccines also consented on IRB protocol 90-40.

Estimated Enrollment:	0
Study Start Date:	May 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Stage 1 - Population: Progressive Metastatic Disease Stage 2 - Population: Rising PSA

Criteria

Inclusion Criteria:

Patients in the first retrospective study (Stage 1) must be part of the 409 patient strong MSKCC cohort with progressive metastatic prostate cancer which was used for the generation of the original nomogram.

For details please see original publication by Smaletz et al. Patients involved in the second retrospective study (Stage 2) must be part of the 223 patients with a rising PSA after surgery or radiation therapy who were treated on conjugate vaccine trials at MSKCC..

Exclusion Criteria:

For details of excluded patients on the clinical metastases castrate disease study, please see original publication by Smaletz et al.4

• (MSKCC - add reference if publication available for rising PSA patients)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578409

Contacts

Contact: Howard I Scher, MD

scherh@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Principal Investigator: Howard I Scher, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

BIOSCIENCES CORPORATION

NYU MEDICAL CENTER

Investigators

Principal Investigator:

Howard I Scher, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Web Site This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Howard I. Scher, MD )
Study ID Numbers:	04-062
Study First Received:	December 19, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00578409
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

castration resistant prostate cancer
progressive castrate metastatic prostate cancer

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

ClinicalTrials.gov processed this record on January 16, 2009