Clinical trial NCT00574899: Prostate Biomarker Study
Official title: Multi-Institutional Inter-SPORE Prostate Biomarker Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Baylor College of Medicine
name: Dana-Farber Cancer Institute
name: University of Washington
name: Fred Hutchinson Cancer Center
name: Johns Hopkins University
name: Mayo Clinic
name: M.D. Anderson Cancer Center
name: Northwestern University
name: University of Michigan
name: University of California, San Francisco
name: University of California, Los Angeles
First posted: 2007-12-17
Enrollment: 32
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 11 cancer centers in the USA

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: pre-treatment and at yearly intervals during follow-up.
Secondary outcomes:
measure: 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.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Eastham, MD
role: PRINCIPAL_INVESTIGATOR
References: