Clinical trial · Observational
Analysis of Cell-free DNA (cfDNA) in Men With Elevated PSA Levels
A Multi-center Prospective Study to Analyze Cancer-derived Cell-free DNA (cfDNA) in Men With Elevated PSA Levels
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Data review
Summary
Brief summary (as posted)
This is a multi-centre prospective study in which blood samples will be taken from 1500 male patients aged between 21-80 scheduled for prostate biopsy. Analysis of cell-free cancer DNA extracted from these samples will be undertaken to determine whether copy number instability scores derived from the cfDNA correlates with PSA screening levels and prostate biopsy results (i.e. Gleason score) in these patients.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood draw | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- CNI correlation with biopsy
- timeFrame
- Through completion of study and all data analysis which may take up to 2 years.
- description
- To determine if copy number instability (CNI scores) derived from analysis of cell-free cancer DNA (cfDNA) in patients undergoing prostate biopsy correlates with biopsy diagnosis of prostate cancer.
Secondary outcomes (2)
- measure
- CNI correlation with BPH
- timeFrame
- Through completion of study and all data analysis which may take up to 2 years.
- description
- To determine if copy number instability (CNI scores) derived from analysis of cell-free DNA (cfDNA) in patients undergoing prostate biopsy can distinguish between biopsy diagnosis of benign prostatic hyperplasia (BPH) and prostate cancer.
- measure
- CNI correlation with PIN
- timeFrame
- Through completion of study and all data analysis which may take up to 2 years.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Who, in the opinion of the site Investigator, have an abnormal PSA level as measured by a CLIA certified laboratory or non-USA equivalent within the last 60 days, and/or 2. Who, in the opinion of the site Investigator, have an abnormal digital rectal examination Exclusion Criteria: 1. Male subjects with active or historical histologically confirmed diagnosis of malignancy 2. Male subjects who have participated in a clinical trial involving an investigational drug within the 28 days prior to signing the informed consent form
References
Publications (3)
- RESULTChou R, Croswell JM, Dana T, Bougatsos C, Blazina I, Fu R, Gleitsmann K, Koenig HC, Lam C, Maltz A, Rugge JB, Lin K. Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2011 Dec 6;155(11):762-71. doi: 10.7326/0003-4819-155-11-201112060-00375. Epub 2011 Oct 7. PMID 21984740
- RESULTBill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Haggman M, Andersson SO, Spangberg A, Andren O, Palmgren J, Steineck G, Adami HO, Johansson JE. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014 Mar 6;370(10):932-42. doi: 10.1056/NEJMoa1311593. PMID 24597866
- RESULTRenard E, Bringer J, Augustin I, Orsetti A, Jaffiol C. [Value of dexamethasone suppression tests in the diagnosis of hypercortisolism of ectopic or adrenal origin]. Presse Med. 1989 Feb 25;18(8):435. No abstract available. French. PMID 2540489