Clinical trial NCT00923221: Collection of Blood From Patients With Prostate Cancer
Official title: Collection of Blood From Patients With Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Of Prostate
Prostate Cancer
Prostatic Neoplasms
Metastatic Prostate Cancer
Prostate
Keywords: Genetic
Prostatic Neoplasms
Genotyping
Venipuncture
Polymorphism
Natural History
Prostate Cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2009-06-18
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary clinical

Brief summary: Background:

* It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role.
* Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene.
* Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others.

Objectives:

-To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state.

Eligibility:

-All participants participating in NCI prostate cancer protocols.

Design:

* Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.
* Blood samples are collected at the initial visit or at follow-up visits.
* DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines.
* Gene variations are correlated with prostate cancer prognosis and prognostic indicators.

Detailed description: Objectives:

-To obtain blood samples from patients with prostate cancer for genotyping analyses.

Eligibility:

- All patients seen in the NCI prostate cancer clinic are eligible.

Design:

* Patients with a prior diagnosis of prostate cancer will be evaluated in the GMB Clinic, NCI.
* Blood samples will be collected after the participant signs the protocol consent form. In general, blood will be collected for genomic DNA one time for this study. Extra samples may be requested if the original sample was not enough. The additional sample can range from one to two tubes of blood (approximately 2-3 teaspoons total). Genomic DNA and white blood cells will each be extracted from these samples to be utilized for genotyping and establishment of individual cell lines.
* Genetic variance will be correlated with prostate cancer prognosis (i.e. time from diagnosis to death) and prognostic indicators (i.e. histological tumor grade).
* Blood samples for the extraction of cell-free DNA (cfDNA) and cell-free RNA (cfRNA) may be collected at multiple timepoints for future investigations
* Healthy controls will not be compared and no correlations will be made with prostate cancer susceptibility.

Eligibility criteria: * INCLUSION CRITERIA:

Individuals 18 years of age and older are eligible.

Individuals with a diagnosis of prostate cancer are eligible.

EXCLUSION CRITERIA:

Children are not eligible.

Primary outcomes:
measure: Acquisition and longitudinal analysis of genomic DNA, cfDNA, and cfRNA from participants with prostate cancer
timeFrame: study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: William D Figg, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eisenberger MA, Blumenstein BA, Crawford ED, Miller G, McLeod DG, Loehrer PJ, Wilding G, Sears K, Culkin DJ, Thompson IM Jr, Bueschen AJ, Lowe BA. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med. 1998 Oct 8;339(15):1036-42. doi: 10.1056/NEJM199810083391504.
citation: Eisenberger MA, Simon R, O'Dwyer PJ, Wittes RE, Friedman MA. A reevaluation of nonhormonal cytotoxic chemotherapy in the treatment of prostatic carcinoma. J Clin Oncol. 1985 Jun;3(6):827-41. doi: 10.1200/JCO.1985.3.6.827.
citation: Ruijter E, van de Kaa C, Miller G, Ruiter D, Debruyne F, Schalken J. Molecular genetics and epidemiology of prostate carcinoma. Endocr Rev. 1999 Feb;20(1):22-45. doi: 10.1210/edrv.20.1.0356. No abstract available.