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Development and Evaluation of a Tumor Marker for Prostate Cancer


No coordinating investigator defined.

No involved investigator sites defined.

EPCA-2, GSTPi, PSA, % free PSA, 2proPSA, BPSA, PBOV-1, JM-27, TSG, IL18, Endoglin (CD105), PCAM-1
Prostate and Urologic Cancers Research Group

Major strides in the early detection, staging, monitoring, and risk stratification of men with prostate cancer have been realized over the last few decades. We have recently witnessed a reduction in the death rate for prostate cancer, stage migration with increased numbers of men with local/regional disease, and a greater understanding of the natural history of progression following recurrence. These advances, while not solely dependant on biomarkers, can be attributed to the discovery of Prostate Specific Antigen (PSA) in the late 1970's. In the wake of these discoveries, we still continue to unnecessarily biopsy men at risk for having prostate cancer to identify the 1:4 with the disease, understage men with presumed local disease, continue to lack an accurate method for staging which can direct treatment options for the individual patient and continue to poorly understand the tumor biology and kinetics of disease progression. Clearly, discovery of a new tumor marker and validation/clinical investigation of the markers are mandatory to advance our knowledge and direct the care of men with prostate cancer. With this research, we intend to evaluate the clinical, diagnostic, and prognostic accuracy of new and existing biomarkers on a prospective serum bank collected from men either participating in early detection programs or engaging in pre or post treatment situations. By increasing our clinical research and specimen collections we hope to further advance the staging and direction for treatment in men with prostate cancer. This study approaches patients scheduled for a prostate biopsy, patients visiting the Urology Outpatient Clinic with PSA elevation, patients scheduled for radical prostatectomy, prostate cancer patients with scheduled appointments in Radiation Oncology and men participating in early prostate cancer detection screenings. Subjects will be excluded from the study if: 1) Subjects have any mental impairment that would hinder the ability to provide informed consent. 2) The subject has undergone a radical prostatectomy and is visiting the urology clinic for a follow up appointment. We can not evaluate the protein profiles in the serum/urine for this group of patients because of prostate removal. 3) Subjects have had previous chemotherapy treatment. Such treatments often induce oxidative damage that could affect protein expression. Therefore, such patients are excluded as their exposure histories may be confounded with respect to exposures relevant to prostate cancer. 4) The patient has had previous prostate surgery. These procedures will affect protein expression. 5) Subjects have had previous cancer other than non-melanoma skin cancer. Systemic oxidative DNA damage is suspected as a potential etiologic factor in a number of other cancers. Therefore, such patients are excluded as their exposure histories maybe confounded with respect to exposures relevant to prostate cancer. Upon receiving consent, urine and blood specimens are collected from the subjects. The urine and blood are then processed and stored in our freezer bank. This study represents little to no risk to the patient. Risks include mild pain and bruising which may result from the needle stick. There is a very small chance of infection. There is also a very small chance that the patient may feel faint or pass out from the needle stick. These are the usual risks associated with phlebotomy. Collection of the urine introduces no increased risk to the patient. Adverse experiences that are both serious and unexpected will be immediately reported by telephone to the Primary Investigator, Alan. W. Partin M.D., Ph.D., (410) 614-4876.

1) Collection and archiving of matched serum and urine specimens for biomarker research. Collected from men who are in the early detection, diagnosis, treatment and monitoring stages for prostate cancer. All specimens are available for collaborative research through proper EDRN/NCI- Investigator approval processes for EDRN purposes. 2)Participation in prospective EDRN coordinated pre-Validation and validation studies of several biomarkers for prostate cancer. 3)Explore analyses of novel tumor marker technologies and multi-variable model development.
Various assay techniques

There are currently no biomarkers annotated for this protocol.

No datasets are currently associated with this protocol.

New Funding Opportunity: Biomarker Development Laboratories for the Early Detection Network: Applications Due May 23

Update: Pre-application webinar information now available.

The National Cancer Institute's Division of Cancer Prevention has released a new funding opportunity to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN). The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers.

The existing BDLs are primarily focused on ovary and gastrointestinal cancers. The proposed BDLs (to be supported under this funding opportunity) should be focused on one or more of the following cancers: breast, prostate and other genitourinary organs, or lung. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be considered.

The newly funded units of the Early Detection Research Network will be announced later in April. Successful applicants have already been notified. Those researchers who were not successful during the last round of applications are encouraged to apply to this opportunity.