Understanding prostate cancer through tissue and fluid samples
Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
This study is trying to understand prostate cancer better by collecting and analyzing blood and tissue samples from men with the disease or at risk for it to find new treatments and ways to predict outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02594202 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze blood, tissue, and fluid samples from men with prostate cancer or those suspected of having it. By examining these samples, researchers hope to uncover the molecular and genetic changes that contribute to the development and progression of prostate cancer. The study involves screening participants, collecting tumor samples, and correlating these with clinical outcomes and imaging results to identify potential new treatments and prognostic biomarkers.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with biopsy-proven or suspected prostate cancer.
Not a fit: Patients with comorbidities that prevent them from undergoing diagnostic or therapeutic interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of novel targeted therapies for prostate cancer.
How similar studies have performed: Other studies have shown success in understanding cancer biology through similar approaches, indicating potential for meaningful advancements.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Peter A Pinto, M.D. — National Cancer Institute (NCI)
- Study coordinator: Karen K Holcomb
- Email: karen.holcomb@nih.gov
- Phone: (240) 974-9026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.