SBIR-STTR Award

Early Detection of Prostate Cancer in Urine
Award last edited on: 4/13/19

Sponsored Program
STTR
Awarding Agency
NIH : NCI
Total Award Amount
$145,271
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Hafiz Ahmed

Company Information

New Horizons Diagnostics Corporation

1450 South Rolling Road
Baltimore, MD 21227
   (443) 543-5755
   contact@nhdiag.com
   www.nhdiag.com

Research Institution

University of Maryland at Baltimore

Phase I

Contract Number: 1R41CA141970-01A2
Start Date: 7/6/10    Completed: 6/30/11
Phase I year
2010
Phase I Amount
$145,271
Prostate cancer is the second most common cancer in men, and the second leading cause of cancer death. However, when prostate cancer is diagnosed in its early stages, it can be effectively treated and cured. Combined with the digital rectal examination, the prostate specific antigen (PSA) test has been widely used to detect prostate cancer in its early stages. An elevated PSA level may be an indication of prostate cancer. However, various conditions such as enlargement or inflammation of prostate can cause elevated levels of PSA. Conversely, PSA levels may be normal despite the presence of prostate cancer. Thus, the PSA screening method for early detection of prostate cancer is not suitable due to highly prevalent false positive and negative PSA test results. Therefore, a reliable marker for early detection of prostate cancer is urgently needed. Transcriptional silencing of tumor suppressor gene expression due to hypermethylation of the gene promoters is believed to contribute to the neoplastic progression. Thus, methylated DNAs can serve as biomarkers for early detection of cancer. But, the methylation of most genes correlates positively with tumor grade and stage and thus the detection of these methylated DNAs is not necessarily suitable to identify prostate cancer at early stages, especially at stages I and II (the critical stages for effective treatment and cure). A prostate cancer gene (PCG) has recently been found to be heavily methylated in stages I and II tumor compared to the normal and later stages of tumor tissues. The methylation in the PCG allows development of PCR-based sensitive and specific tools that clearly identify the early stages of prostate cancer in tissues as well as in biological fluids such as serum and urine. The goal of the proposed studies is to establish 'proof of concept' using a large number of urine specimens. Results from these studies in combination with PSA test result will lead to the development of a non-invasive diagnostic tool not only for early detection, but also for therapeutic guidance and recurrence monitoring of prostate cancer in urine. PUBLIC HEALTH RELEVANCE Patients with prostate cancer can be effectively treated and cured, when diagnosed in early stages (i.e. the stages when the cancer is still confined to the prostate gland). The objective of this project is to develop a non-invasive, sensitive and specific method that clearly identifies the early stages of prostate cancer in urine.

Thesaurus Terms:
"2(1h)-Pyrimidinone, 4-Amino-; Ajcc; Accounting; Alleles; Allelomorphs; American Joint Committee On Cancer; Anti-Oncogenes; Antibiotic Therapy; Antibiotic Treatment; Antioncogenes; Armed Forces Personnel; Assay; Bacteriophages; Bears; Benign Prostatic Hypertrophy; Bioassay; Biologic Assays; Biological; Biological Assay; Biopsy; Blood Serum; Body Tissues; Cbp-30; Cbp-35; Cbp35; Cancer Cause; Cancer Etiology; Cancer Genes; Cancer Patient; Cancer Screening For Patients; Cancer Staging; Cancer Of Prostate; Cancer-Promoting Gene; Cancers; Carbohydrate-Binding Protein 35; Cessation Of Life; Collection; Colloidal Gold; Cpg Islands; Cpg-Rich Islands; Cytosine; D-Galactose Chemosensory Receptor; D-Galactose-Binding Protein; D-Galactose-Hydrogen Symport Protein; Dna; Dre; Death; Decontamination; Deoxyribonucleic Acid; Detection; Development; Diagnosis; Diagnostic; Diagnostic Neoplasm Staging; Digital Rectal Examination; Disease; Disorder; Ec 2.5.1.18; Ec 3.4.21.34; Early Diagnosis; Emerogenes; Epsilon-Binding Protein; Figs; Figs - Dietary; Fletcher Factor; Fluorescence; Food; Funding; Gst; Galp Transport Protein; Galectin 3; Gene Expression; Genes; Genes, Cancer Suppressor; Genes, Onco-Suppressor; Genital System, Male, Prostate; Glutathione Organic Nitrate Ester Reductase; Glutathione S-Alkyltransferase; Glutathione S-Aralkyltransferase; Glutathione S-Aryltransferase; Glutathione S-Epoxidetransferase; Glutathione S-Transferase; Glutathione Transferase; Goals; Gold Colloid; Grant; Hap; Hl-29; Heme Transfer Protein; Human; Human Prostate; Human Prostate Gland; Human, General; Hypermethylation; Inflm; Ige Binding Protein; Igebp; Inflammation; Klk3; Kallikrein 3; L-29 Lectin; L-31; L-34; L30 Lectin; Lgals3; Lead; Legal Patent; Ligandins; Liquid Substance; Lyta Enzyme; Lytic Enzyme; Mac-2 Antigen; Macrophage-2 Antigen; Malignant Neoplasms; Malignant Tumor; Malignant Tumor Of The Prostate; Malignant Neoplasm Of Prostate; Malignant Prostatic Tumor; Man (Taxonomy); Man, Modern; Methods; Methylation; Military; Military Personnel; Monitoring For Recurrence; Nr1b2; Neoplasm Staging; Newly Diagnosed; Office Management; Oncogenes; Oncogenes, Recessive; Oncogenes-Tumor Suppressors; Outcome; P-30 Antigen; Patents; Patients; Pb Element; Phages; Phase; Plasma Kallikrein Precursor; Plasma Prekallikrein; Principal Investigator; Programs (Pt); Programs [publication Type]; Promoter; Promoters (Genetics); Promotor; Promotor (Genetics); Prostate; Prostate Ca; Prostate Cancer; Prostate Gland; Prostate Specific Antigen Preproprotein; Prostate-Specific Antigen; Prostatic Cancer; Prostatic Gland; Prostatic Hyperplasia, Benign; Prostatic Hypertrophy, Benign; Protein Family; Protein Methylation; R01 Mechanism; R01 Program; Rarb; Rarb Gene; Rpg; Rrb2; Rx[{..}]glutathione R-Transferase; Research Grants; Research Project Grants; Research Projects; Research Projects, R-Series; Research Specimen; S-Hydroxyalkyl Glutathione Lyase; Sampling; Screening For Prostate Cancer; Screening For Cancer; Screening Procedure; Semenogelase; Seminin; Sensitivity And Specificity; Serum; Serum Markers; Site; Specificity; Specimen; Staging; System; System, Loinc Axis 4; Technology; Telomerase; Test Result; Testing; Therapeutic; Tissues; Transforming Genes; Tumor Staging; Tumor Suppressing Genes; Tumor Suppressor Genes; Tumor Tissue; United States; Urinary System, Urine; Urine; Ursidae; Ursidae Family; Bacterial Virus; Base; Benign Prostate Hyperplasia; Beta-D-Galactoside Transport Protein; Biomarker; Bisulfite; Blind; Cancer Diagnosis; Cancer Progression; Cohort; Design; Designing; Disease/Disorder; Early Cancer Detection; Early Detection; Effective Therapy; Emergency Service Personnel; Emergency Service Responder; Emergency Service/First Responder; First Responder; Fluid; Galactose Chemoreceptor Protein; Galactose Transport Protein; Galactose-H+ Symport Protein; Galactose-Binding Protein; Gamma-Seminoprotein; Glutathione Aralkyltransferase; Glutathione Aryltransferase; Hk3 Kallikrein; Heavy Metal Pb; Heavy Metal Lead; Hydrogen Sulfite; Hydrosulfite; Improved; Kininogenin; Liquid; Luminescence; Major Amidase; Malignancy; Member; Men; Men's; Neoplasm Progression; Neoplasm/Cancer; Neoplastic Progression; New Technology; Oncosuppressor Gene; Phase 1 Study; Phase 2 Study; Prognostic; Programs; Prostate Cancer Early Detection; Public Health Relevance; Rapid Detection; Screening; Screenings; Successful Intervention; Tool; Treatment Of Bacterial Diseases; Treatment Of Bacterial Infectious Disease; Tumor; Tumor Progression"

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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