Prostate CancerNCT02594202
Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
An observational study of Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want to study blood, tissue, and fluid samples of people with prostate cancer. This will help them understand any changes in cells and genes. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2015to 1 Jan 2037
- 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: Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
Who may be able to join
- Adults (greater than or equal to 18 years of age) with biopsy-proven or suspected prostate cancer (elevated PSA abnormal digital rectal exam (DRE) abnormal prostate MRI, or family history) who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
- ECOG performance status of 0-2
- Must be willing and able to provide informed consent
- PSA > or equal to 1.0 ng/ml (for patients aged 30 - 49 years) OR
- PSA > or equal to 2.5 ng/ml (for patients 50 years or older) OR
- Abnormal DRE (i.e. enlarged, asymmetric, nodular, firm or tender) OR
- Abnormal prostate MRI finding OR
- Family history of first degree relatives (brother or father) with prostate cancer or first-degree relatives (mother or sister) with breast or ovarian cancer
Who cannot join
- 1. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
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
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want to study blood, tissue, and fluid samples of people with prostate cancer. This will help them understand any changes in cells and genes. These changes might lead to the development and progression of prostate cancer. Researchers think the study could lead to new treatments.
Read more
Objective:
To understand the changes in cells and genes that lead to the development and progression of prostate cancer. This could lead to new treatments.
Eligibility:
Men ages 18 and older who have or are suspected to have prostate cancer
Design:
Participants will be screened with physical exam and medical history.
Participants will send tissue blocks of their tumor, if possible. If not, they will provide unstained slides of tumor tissue.
Participants may provide samples of blood, urine, saliva, and prostate secretions.
Participants may have imaging tests. They will lie in a machine that takes pictures of their body. These tests include:
MRI of the prostate
CT of the abdomen and pelvis
Chest x-ray
Participants may need a biopsy or surgery for treatment of their cancer. If so, researchers will collect tissue.
Participants may answer questions about their prostate cancer and quality of life.
Participants may have follow-up visits or other treatments. They may have follow-up phone calls every few months.
Read the detailed description
Background:
- Prostate carcinoma is the second most common malignancy diagnosed in men. Approximately 1 in 6 men will be diagnosed with prostate cancer in their lifetime.
- Understanding the molecular mechanisms and genomic alterations that cause prostate carcinoma will provide the foundation for the development of novel targeted therapeutic agents for this disease. Since 1982 investigators in the Urologic Oncology Branch have been studying the genetic basis of urologic cancers. The identification of the genes for cancer of the kidney has led to the approval by the FDA of a number of new agents for patients with advanced disease. Similarly, it is our goal to study the cancer biology (genomic, molecular, and cellular biology) of prostate carcinoma in order to develop novel treatment strategies.
- Collection of patient tumor samples allows us to study molecular and biologic pathways and develop novel targeted therapies. Correlation of these samples with radiographical findings and clinical outcomes in patients allows us to predict and understand clinical outcomes and possibly develop predictive and/or prognostic biomarkers.
Objective:
Collect blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue from patients with known or suspected prostate cancer for the purpose of elucidating the molecular mechanisms of carcinogenesis in prostate cancer and ultimately, identifying novel therapeutic targets.
Eligibility:
- Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or followup/surveillance for their neoplasm.
Design:
- Tissue acquisition protocol in which normal and malignant prostate cancer tissues may be obtained at the time of clinically indicated diagnostic and/or therapeutic intervention.
- Blood and urine samples for research will be obtained at baseline and follow-up intervals. Expressed prostatic secretions may be collected at baseline and follow-up intervals. Additionally, saliva may be collected at baseline.
- No investigational or experimental therapy will be given as part of this protocol.
- Conditions
- Prostate Cancer
- Keywords
- Specimen Collection, Carcinogenesis, Prognostic Biomarkers, Molecular Mechanims, Cell Lines, Natural History
- Medical subject headings
- Prostatic Neoplasms, Carcinogenesis
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 | Adults (= 18 years of age) with biopsy-proven or suspected prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer
Collection of blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue
Measured: Ongoing
Secondary outcomes (3)
prostate cancer cell lines
Develop stable prostate cancer cell lines from procured tissue when feasible
Measured: ongoing
Natural history of prostate cancer
Collect detailed history, pathologic data, perioperative findings, and treatment data to better characterize the natural and clinical histories of prostate cancer when feasible
Measured: ongoing
Molecular profiling
whole genomic sequence characterizations, identification of specific mutations or single nucleotide polymorphisms (SNPs), comparative genomic hybridization, messenger and microRNA sequencing and expression, RNA Seq, DNA methylation (epigenetics), DNA copy number, and expression profiling
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start21 Dec 2015
- Primary completion1 Jan 2036 (estimated)
- Study completion1 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter A Pinto, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594202
- Sponsor's protocol ID
- 160010
- Other IDs
- 16-C-0010
- Status last verified
- 13 Oct 2026
- First submitted
- 31 Oct 2015
- 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
Merriman KM, Harmon SA, Belue MJ, Yilmaz EC, Blake Z, Lay NS, Phelps TE, Merino MJ, Parnes HL, Law YM, Gurram S, Wood BJ, Choyke PL, Pinto PA, Turkbey B. Comparison of MRI-Based Staging and Pathologic Staging for Predicting Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. AJR Am J Roentgenol. 2023 Dec;221(6):773-787. doi: 10.2214/AJR.23.29609. Epub 2023 Jul 5.
PubMed 37404084
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
- Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
- ClinicalTrials.gov ID
- NCT02594202
- Acronym / sponsor ID
- 160010
- Conditions
- Prostate Cancer
- Keywords
- Specimen Collection, Carcinogenesis, Prognostic Biomarkers, Molecular Mechanims, Cell Lines, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- 1 Jan 2036 (estimated)
- Study completion
- 1 Jan 2037 (estimated)
- First posted
- 3 Nov 2015 (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:
Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want to study blood, tissue, and fluid samples of people with prostate cancer. This will help them understand any changes in cells and genes. These changes might lead to the development and progression of prostate cancer. Researchers think the study could lead to new treatments.
Objective:
To understand the changes in cells and genes that lead to the development and progression of prostate cancer. This could lead to new treatments.
Eligibility:
Men ages 18 and older who have or are suspected to have prostate cancer
Design:
Participants will be screened with physical exam and medical history.
Participants will send tissue blocks of their tumor, if possible. If not, they will provide unstained slides of tumor tissue.
Participants may provide samples of blood, urine, saliva, and prostate secretions.
Participants may have imaging tests. They will lie in a machine that takes pictures of their body. These tests include:
MRI of the prostate
CT of the abdomen and pelvis
Chest x-ray
Participants may need a biopsy or surgery for treatment of their cancer. If so, researchers will collect tissue.
Participants may answer questions about their prostate cancer and quality of life.
Participants may have follow-up visits or other treatments. They may have follow-up phone calls every few months.
Detailed description
Background:
- Prostate carcinoma is the second most common malignancy diagnosed in men. Approximately 1 in 6 men will be diagnosed with prostate cancer in their lifetime.
- Understanding the molecular mechanisms and genomic alterations that cause prostate carcinoma will provide the foundation for the development of novel targeted therapeutic agents for this disease. Since 1982 investigators in the Urologic Oncology Branch have been studying the genetic basis of urologic cancers. The identification of the genes for cancer of the kidney has led to the approval by the FDA of a number of new agents for patients with advanced disease. Similarly, it is our goal to study the cancer biology (genomic, molecular, and cellular biology) of prostate carcinoma in order to develop novel treatment strategies.
- Collection of patient tumor samples allows us to study molecular and biologic pathways and develop novel targeted therapies. Correlation of these samples with radiographical findings and clinical outcomes in patients allows us to predict and understand clinical outcomes and possibly develop predictive and/or prognostic biomarkers.
Objective:
Collect blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue from patients with known or suspected prostate cancer for the purpose of elucidating the molecular mechanisms of carcinogenesis in prostate cancer and ultimately, identifying novel therapeutic targets.
Eligibility:
- Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or followup/surveillance for their neoplasm.
Design:
- Tissue acquisition protocol in which normal and malignant prostate cancer tissues may be obtained at the time of clinically indicated diagnostic and/or therapeutic intervention.
- Blood and urine samples for research will be obtained at baseline and follow-up intervals. Expressed prostatic secretions may be collected at baseline and follow-up intervals. Additionally, saliva may be collected at baseline.
- No investigational or experimental therapy will be given as part of this protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adults (= 18 years of age) with biopsy-proven or suspected prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
Key inclusion criteria (8 listed)
Key exclusion criteria (1 listed)
- 1. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
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
Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer
Time frame: Ongoing
Collection of blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue
3 secondary outcomes
prostate cancer cell lines
Time frame: ongoing
Natural history of prostate cancer
Time frame: ongoing
Molecular profiling
Time frame: ongoing
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.
- Derived from this study: PubMed 37404084Merriman KM, Harmon SA, Belue MJ, Yilmaz EC, Blake Z, Lay NS, Phelps TE, Merino MJ, Parnes HL, Law YM, Gurram S, Wood BJ, Choyke PL, Pinto PA, Turkbey B. Comparison of MRI-Based Staging and Pathologic Staging for Predicting Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. AJR Am J Roentgenol. 2023 Dec;221(6):773-787. doi: 10.2214/AJR.23.29609. Epub 2023 Jul 5.
- 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.
Peter A Pinto, M.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 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 8 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 Karen K Holcomb ((240) 974-9026, karen.holcomb@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer (time frame: Ongoing). 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 NCT02594202, which also lists 1 linked publication.
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.