Prostate Biomarker Study

October 18, 2015 updated by: Memorial Sloan Kettering Cancer Center

Multi-Institutional Inter-SPORE Prostate Biomarker Study

Radical Prostatectomy (removal of the prostate) or radiation therapy provide excellent outcomes for patients with localized (confined to one area) disease, yet there is still no effective treatment once the disease has spread beyond the prostate gland. Typically, a serum PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy and other tests help to classify the patient's disease according to the likelihood of a recurrence. However, these assessments are imperfect. There is a need to identify and evaluate prostate biomarkers that will provide exact information regarding the likelihood of a recurrence (prediction) of prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Inter-SPORE Prostate Biomarkers Study (IPBS) was established to prospectively collect and analyze biological specimens to predict and validate outcomes after treatment for prostate cancer. The study population will consist of patients scheduled to receive standard of care therapy for localized prostate cancer, either radical prostatectomy (RP) or radiation therapy (XRT; includes external beam radiation, brachytherapy, or both). Seven hundred (700) patients (350 RP, 350 XRT) will be recruited from 11 SPORE sites over a two-year interval. We will collect serum, plasma, lymphocytes, and prostate tissue samples for distribution to collaborating biomarker validation sites at other prostate SPOREs, along with clinical and epidemiologic data.

Study Type

Observational

Enrollment (Actual)

32

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
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
    • New York
      • New York, New York, United States, 10021
        • 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

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

11 cancer centers in the USA

Description

Inclusion Criteria:

  • Males, 35 years of age or older, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland.
  • Biopsy performed at the SPORE institution.
  • No prior therapy for prostate cancer (patients who receive neoadjuvant therapy after collection of blood and biopsy samples are eligible).
  • The patient should have 2 or more cores involved with carcinoma. The minimum amount of tumor submitted should be 5 mm, or at least 40% of the core involved with tumor. (This amount can be made up from 2 positive cores if 1 core is insufficient).
  • Patients with clinical stage T1-T2a NXM0 prostate cancer who elect to be treated with RP or XRT (includes external beam radiation, brachytherapy, or both) at the SPORE institution.
  • Patients with a nomogram predicted 5-year probability of freedom from biochemical recurrence (Kattan 1998) of less than or equal to 85% (patients with intermediate risk of recurrence).
  • Ability and willingness to sign informed consent

Exclusion Criteria:

  • Participation in a therapeutic clinical trial with an experimental agent.
  • Previous cancer of any kind except non-melanoma skin cancer
  • Previous surgical or minimally invasive treatment for enlarged prostate (e.g. TURP, TUNA, TUIP, laser, microwave)
  • Use of anti-androgen drugs during the 6 months prior to diagnosis
  • Use of 5-alpha-reductase inhibitors during the 6 months prior to diagnosis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
patients scheduled to receive standard of care with a Radical prostatectomy
Other: Questioners, blood specimens, prostate tissue specimens

You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.

Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat.
2
patients scheduled to receive standard of care with radiation therapy
Other: Questioners, blood specimens, prostate tissue specimens

You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.

Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coll & contrib bio spec to Inter-SPORE Prostate Biomarker Study men with clinical localized prostate ca sched to get standard of care therapy for localized prost ca, either radical prostatectomy, RT therapy
Time Frame: pre-treatment and at yearly intervals during follow-up.
pre-treatment and at yearly intervals during follow-up.

Secondary Outcome Measures

Outcome Measure
Time Frame
To participate in the IPBS by conducting a prospective analysis of the prognostic utility of serum hK2 in predicting biochemical recurrence after definitive local therapy for prostate cancer.
Time Frame: conclusion of study
conclusion of study

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Johns Hopkins University
M.D. Anderson Cancer Center
Mayo Clinic
Baylor College of Medicine
University of California, Los Angeles
Northwestern University
Dana-Farber Cancer Institute
University of Michigan
University of Washington
University of California, San Francisco
Fred Hutchinson Cancer Center
Harvard University

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, 2007

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (ESTIMATE)

December 17, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 18, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-053

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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