NCT02594202 Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
| NCT ID | NCT02594202 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2015-12-21 |
| Primary Completion | 2036-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2015-12-21 with a primary completion date of 2036-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Peter A Pinto, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT02594202 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02594202 currently recruiting?
Yes, NCT02594202 is actively recruiting participants. Contact the research team at karen.holcomb@nih.gov for enrollment information.
Where is the NCT02594202 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02594202 clinical trial?
NCT02594202 is sponsored by National Cancer Institute (NCI). The principal investigator is Peter A Pinto, M.D. at National Cancer Institute (NCI). The trial plans to enroll 3,000 participants.
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