Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
2 other identifiers
observational
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedStudy Start
First participant enrolled
December 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2037
March 27, 2026
March 24, 2026
20 years
October 31, 2015
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer
Collection of blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue
Ongoing
Secondary Outcomes (3)
prostate cancer cell lines
ongoing
Natural history of prostate cancer
ongoing
Molecular profiling
ongoing
Study Arms (1)
1
Adults (= 18 years of age) with biopsy-proven or suspected prostate cancer
Eligibility Criteria
Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
You may qualify if:
- 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
You may not qualify if:
- \. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
Merriman KM, Harmon SA, Belue MJ, Yilmaz EC, Blake Z, Lay NS, Phelps TE, Merino MJ, Parnes HL, Law YM, Gurram S, Wood BJ, Choyke PL, Pinto PA, Turkbey B. Comparison of MRI-Based Staging and Pathologic Staging for Predicting Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. AJR Am J Roentgenol. 2023 Dec;221(6):773-787. doi: 10.2214/AJR.23.29609. Epub 2023 Jul 5.
PMID: 37404084DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A Pinto, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2015
First Posted
November 3, 2015
Study Start
December 21, 2015
Primary Completion (Estimated)
January 1, 2036
Study Completion (Estimated)
January 1, 2037
Last Updated
March 27, 2026
Record last verified: 2026-03-24
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
- Access Criteria
- Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.