Prostate Biomarker Study

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Questioners, blood specimens, prostate tissue specimens

• Registration Number: NCT00574899
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-18
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Questioners, blood specimens, prostate tissue specimens	patients scheduled to receive standard of care with a Radical prostatectomy
2	Questioners, blood specimens, prostate tissue specimens	patients scheduled to receive standard of care with radiation therapy

Primary Outcome Measures

Name	Time	Method
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	pre-treatment and at yearly intervals during follow-up.

Secondary Outcome Measures

Name	Time	Method
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.	conclusion of study

Trial Locations

Locations (2)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

UCLA; 🇺🇸 Los Angeles, California, United States