Cancer Of ProstateNCT00923221
Collection of Blood From Patients With Prostate Cancer
An observational study of Cancer Of Prostate and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer Of Prostate, Prostate Cancer, Prostatic Neoplasms
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2007to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Primary clinical
Who may be able to join
- Individuals 18 years of age and older are eligible.
- Individuals with a diagnosis of prostate cancer are eligible.
Who cannot join
- Children are not eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
- Conditions
- Cancer Of Prostate, Prostate Cancer, Prostatic Neoplasms, Metastatic Prostate Cancer, Prostate
- Keywords
- Genetic, Prostatic Neoplasms, Genotyping, Venipuncture, Polymorphism, Natural History, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Participant samples | Blood samples from participants with diagnosed prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start28 Feb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer Of ProstateStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William D Figg, Pharm.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923221
- Sponsor's protocol ID
- 070100
- Other IDs
- 07-C-0100
- Status last verified
- 20 Jan 2026
- First submitted
- 17 Jun 2009
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 9761805Eisenberger 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 2409240Ruijter 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood From Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00923221
- Acronym / sponsor ID
- 070100
- Conditions
- Cancer Of Prostate, Prostate Cancer, Prostatic Neoplasms, Metastatic Prostate Cancer, Prostate
- Keywords
- Genetic, Prostatic Neoplasms, Genotyping, Venipuncture, Polymorphism, Natural History, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 28 Feb 2007 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Participant samples | – | –Blood samples from participants with diagnosed prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary clinical
Key inclusion criteria (2 listed)
- Individuals 18 years of age and older are eligible.
- Individuals with a diagnosis of prostate cancer are eligible.
Key exclusion criteria (1 listed)
- Children are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acquisition and longitudinal analysis of genomic DNA, cfDNA, and cfRNA from participants with prostate cancer
Time frame: study duration
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 9761805Eisenberger 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.
- Background: PubMed 2409240Eisenberger 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.
- Background: PubMed 10047972Ruijter 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William D Figg, Pharm.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Of Prostate and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula A Carter, R.N. ((240) 858-3191, pcartera@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition and longitudinal analysis of genomic DNA, cfDNA, and cfRNA from participants with prostate cancer (time frame: study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00923221, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.