Recruiting

Prostate Cancer Care

Sponsor:

National Cancer Institute (NCI)

Code:

NCT02594202

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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.

Conditions

Prostate Cancer

Study ID

NCT02594202

Start date

Dec 21, 2015

Status verified date

Oct 13, 2026

Completion date

Jan 1, 2037

Anticipated

Primary completion date

Jan 1, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

1. 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.
2. ECOG performance status of 0-2
3. Must be willing and able to provide informed consent
4. PSA > or equal to 1.0 ng/ml (for patients aged 30 - 49 years) OR
5. PSA > or equal to 2.5 ng/ml (for patients 50 years or older) OR
6. Abnormal DRE (i.e. enlarged, asymmetric, nodular, firm or tender) OR
7. Abnormal prostate MRI finding OR
8. Family history of first degree relatives (brother or father) with prostate cancer or first-degree relatives (mother or sister) with breast or ovarian cancer

EXCLUSION CRITERIA:

1\. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Adults (= 18 years of age) with biopsy-proven or suspected prostate cancer

Primary outcome measure

  • Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Karen K Holcomb

(240) 974-9026karen.holcomb@nih.gov

Peter A Pinto, M.D.

(240) 858-3700pp173u@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Oct 16, 2026

Last verified

Oct 13, 2026

Keywords

  • Specimen Collection
  • Carcinogenesis
  • Prognostic Biomarkers
  • Molecular Mechanims
  • Cell Lines
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.