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RecruitingNCT00923221Updated Nov 9, 2026

Collection of Blood From Patients With Prostate Cancer

An observational study in Cancer Of Prostate, Prostate Cancer and Prostatic Neoplasms, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by National Cancer Institute (NCI) · Observational

From the registry’s dates

  • Started Feb 2007; still recruiting 19 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
Male
01

Study 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.
Read the 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.
02

Conditions studied

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

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Keywords

  • Genetic
  • Prostatic Neoplasms
  • Genotyping
  • Venipuncture
  • Polymorphism
  • Natural History
  • Prostate Cancer
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary clinical

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Individuals 18 years of age and older are eligible.

Individuals with a diagnosis of prostate cancer are eligible.

Exclusion criteria

EXCLUSION CRITERIA:

Children are not eligible.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • 1/Participant samples

    Blood samples from participants with diagnosed prostate cancer

06

What researchers measure

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

    Time frame: study duration

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 9761805 ↗
  • 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. PubMed 2409240 ↗
  • 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. PubMed 10047972 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00923221
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 18, 2009
Start date
Feb 28, 2007
Last update
Nov 9, 2026

Study contacts

Paula A Carter, R.N.
Contact
pcartera@mail.nih.gov
(240) 858-3191
William D Figg, Pharm.D.
Contact
figgw@mail.nih.gov
(240) 760-6179
William D Figg, Pharm.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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