NCT00923221

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
Last Updated

May 1, 2026

Status Verified

January 20, 2026

First QC Date

June 17, 2009

Last Update Submit

April 30, 2026

Conditions

Prostate CancerProstatic NeoplasmsMetastatic Prostate CancerProstateCancer Of Prostate

Keywords

GeneticProstatic NeoplasmsGenotypingVenipuncturePolymorphismNatural HistoryProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1/Participant samples

Blood samples from participants with diagnosed prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary clinical

You may qualify if:

  • Individuals 18 years of age and older are eligible.
  • Individuals with a diagnosis of prostate cancer are eligible.

You may not qualify if:

  • Children are not eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related 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.

    PMID: 9761805BACKGROUND

  • 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.

    PMID: 2409240BACKGROUND

  • 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.

    PMID: 10047972BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • William D Figg, Pharm.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula A Carter, R.N.

CONTACT

(240) 858-3191pcartera@mail.nih.gov

William D Figg, Pharm.D.

CONTACT

(240) 760-6179figgw@mail.nih.gov

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

February 28, 2007

Last Updated

May 1, 2026

Record last verified: 2026-01-20

Data Sharing

IPD Sharing
Will share

All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US(1)