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Completed

NCT Number: NCT00574899

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

35 year and older

Sex eligibility

Male

Study type

Observational

Primary location

UCLA, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questioners, blood specimens, prostate tissue specimens

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

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

Registry information

Official study title

Multi-Institutional Inter-SPORE Prostate Biomarker Study

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2007
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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