Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
Recruiting · NCT02594202 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Cancer Institute (NCI)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Exclusion criteria
- \. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
Where it is running
1 location listed across 1 US state.
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States