Clinical trial · Observational
Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Adults (= 18 years of age) with biopsy-proven or suspected prostate cancer
Primary outcomes (1)
- measure
- Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer
- timeFrame
- Ongoing
- description
- Collection of blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue
Secondary outcomes (3)
- measure
- prostate cancer cell lines
- timeFrame
- ongoing
- description
- Develop stable prostate cancer cell lines from procured tissue when feasible
- measure
- Natural history of prostate cancer
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
* 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.
References
Publications (1)
- DERIVEDMerriman 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 37404084