Prostate Biomarker Study

Prostate Cancer Clinical Trial

Official title:

Multi-Institutional Inter-SPORE Prostate Biomarker Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574899
• Other study ID #: 07-053
• Status: Completed
• Phase: N/A
• First received: December 13, 2007
• Last updated: October 18, 2015
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: October 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (13)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Baylor College of Medicine, Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research 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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center