Identification of protein and genetic biomarkers of prostate cancer and risk factors for progression of disease

Abbreviated Name
Identification of protein and genetic biomarkers of prostate cancer
Lead Investigator
Leach, Robin JUniversity of Texas Health Science Center at San Antonio
Coordinating Investigator
No coordinating investigator
Involved Investigators


Purpose/Objectives To collect biological samples from subjects with prostate cancer to improve the accuracy of screening tests, identify markers that will predict how aggressive prostate cancers can be, and provide accurate information about how rapidly prostate cancer can worsen. Research Design/Plan Men with the following criteria will be consented for this protocol. 1.) ≥5 years post prostate cancer diagnosis, between the ages of 30 and 99 years of age (OR). (Targeted recruits.) 2.) Diagnosed with prostate cancer with a Gleason’s score ≥ 4+3=7, or 3+3 with survivorship of 5 years, or is positive for metastatic disease, or recurrence or has an unexplained increase in their serum PSA after treatment. (Targeted recruits.) 3.) Diagnosed with prostate cancer in the past in whom follow-up is available. Diagnostic and prognostic data will be collected as well as approximately 2 tablespoons of blood samples will be drawn from a vein in the subjects arm for processing and storage in the GU Tissue Bank (“Tissue Bank and Data Base for Urologic Diseases” HSC20050234H). The study involves a single visit with annual telephone follow-up interviews to update the treatment and prognostic data. Methods Potential subjects will be identified through recruitment at clinics, through advertisement, at prostate cancer lectures, support group meetings, and by referral. Once a potential subject has been identified, they will be informed about the study and the inclusion criteria to see if they qualify. If the subject qualifies and provides informed consent, the study staff will collect and record demographic and disease information and completion of the AUA questionnaire. The subjects will be called annually to updates by the research staff. Clinical Relevance Cancer statistics from the early 1990s reflect both a decline in prostate cancer mortality and a “downstaging” of the disease at the time of diagnosis. Thus, the number of men who have metastases at the time of diagnosis of their initial diagnosis of prostate cancer has decreased in parallel with a decline in mortality. These favorable statistical trends followed the introduction of prostate specific antigen (PSA) as a screening assay for prostate cancer in the late 1980s and imply that earlier diagnosis and treatment provide benefit to the population. However, large scale screening activity must be carefully scrutinized for less desirable outcomes such as “over diagnosis” of biologically indolent disease and failure to diagnose aggressive disease. When screening techniques are introduced into large populations, the number of false positives and false negatives is quite high even when the specificity of a test approaches 95%. Men who are “false positives” needlessly undergo biopsy and the associated anxiety. The detection rate using PSA alone is approximately 25%. The information gained from this study may potentially increase the sensitivity and specificity of prostate cancer screenings, eliminate many of the false negatives and help detect early relapse of disease.


Expand recruitment of our prevalent prostate cancer protocol to enroll subjects with prostate cancer into a follow up protocol to improve ability to correlate biologic samples with prostate cancer outcomes. We will target men who are > 5 years after diagnosis and treatment in whom disease progression or recurrence has not occurred and men who have documented metastatic or biochemical recurrences to allow assessment of constitutional variants related to disease prognosis and outcome. Subaim is to obtain DNA from collaborator at NCI from men with documented metastasis (n>500) and perform genetic analysis.

Analytic Method

Assuming a two-sided test of binomial proportions with α=0.05 and power=0.80, and a 1:1 case-control ratio of 800 cases and 800 controls, will provide greater than 80% power to detect odds ratios of ≥1.50 when the prevalence of a marker occurs in 20% of the control population. Likewise, we will be able to detect an odds ratio >1.75 (for 833 cases, or odds ratio ≥ 1.77 for 800 cases) when the marker is present in 5% of control subjects as shown in Table 9.


The following publications are associated or resulted from this project but were unable to add through publication section: PMID: 21592109 PMID: 23476788 [PubMed] PMCID: PMC3583061 PMID: 21555517 PMID: 20576103 PMID: 20086112 PMID: 19683737 PMID: 19680268 PMID: 19528667 PMID: 19505920 PMID: 18544568 PMID: 18483391 PMID: 17908993



  • No biomarkers available at this time for this protocol.

Data Collections

  • No data collections available at this time for this protocol.
Finish Date
Jun 1 2020
Protocol ID
Protocol Type
Field of Research
Collaborative Group
Prostate and Urologic Cancers Research Group
Cancer Types
  • Malignant neoplasm of prostate

Associated Forms