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Collecting Tissue and Samples from Men with Prostate Cancer

Studies blood, tissue and fluid samples from men with prostate cancer.

Plain-language title generated from the registry record
Registry title: Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue

Key facts

Where
Bethesda, United StatesSee the site

Where in United States

  • National Institutes of Health Clinical CenterBethesda, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
National Cancer Institute (NCI)
Trial code
NCT02594202
Record updated
9 November 2026
Original description
Background:Read full original descriptionShow less

Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue

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.

...

Exclusion: Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.

INCLUSION CRITERIA:; 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.

ClinicalTrials.gov NCT02594202