Collection of Blood From Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Collection of Blood From Patients With Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00923221
• Other study ID #: 070100
• Secondary ID: 07-C-0100
• Status: Recruiting
• Start date: February 28, 2007

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Paula A Carter, R.N.
• Phone: (240) 858-3191
• Email: pcartera[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00899249

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

Patients 18 years of age and older are eligible.

Patients with a diagnosis of prostate cancer are eligible.

EXCLUSION CRITERIA:

Children are not eligible.

Related Conditions & MeSH terms

• Cancer Of Prostate
• Metastatic Prostate Cancer
• Prostate
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition and longitudinal analysis of genomic DNA, cfDNA, and cfRNA from participants with prostate cancer	Acquisition and longitudinal analysis of genomic DNA, cfDNA, and cfRNA from participants with prostate cancer to aid in understanding the mechanisms of prostate carcinogenesis and progression	study duration

External Links

•   NIH Clinical Center Detailed Web Page