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

Who can join

Ages 18 and older · Men

* 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.

About the 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.

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.

Sponsor: National Cancer Institute (NCI) · Participants: 3,000 · Started: Dec 21, 2015

Contact the study team

• Karen K Holcomb · Phone: (240) 974-9026
• Peter A Pinto, M.D. · Phone: (240) 858-3700

Official record on ClinicalTrials.gov — NCT02594202

Locations in the U.S.

Conditions

• Prostate Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.