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

December 16, 2015 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

758

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Aureon Biosciences, Inc.
NYU MEDICAL CENTER

Investigators

  • Principal Investigator: Howard I Scher, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 21, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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