- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04079699
Predicting Prostate Cancer in Elderly Men
Predicting Prostate Cancer Using a Panel of Plasma and Urine Biomarkers Combined in an Algorithm in Elderly Men Above 70 Years
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND Prostate biopsy is currently the standard of care for prostate cancer diagnosis, oftentimes reflexed after the detection of an elevated serum prostate-specific antigen (PSA). Unfortunately, prostate biopsy is not without potential complications, which include discomfort, pain, bleeding, and infections ranging from cystitis to septic sepsis and even death. Bleeding has been reported in 6-13% of patients undergoing prostate biopsy, while 0.3-4% experience admission with sepsis. Furthermore, some newly diagnosed prostate cancers are indolent while other may be more aggressive with metastatic potential, with resultant risk of death. A PSA level ≥4.0 ng/ml is frequently used as a threshold warranting a biopsy evaluation. Elevated PSA level may reflect benign prostatic hyperplasia (BPH), inflammation, or malignancy. Some series suggest that only 20-30% of patients with PSA 4 - 10 ng/ml, have prostate cancer, resulting in a high number of patients undergoing an unnecessary biopsy. We recently reported the ability of "Liquid Biopsy" to predict the presence of aggressive prostate cancer using a combination of biomarkers detected in urine and peripheral blood plasma. Concluding that "Liquid Biopsy" can predict the presence of aggressive prostate cancer (GS ≥7).
AIM With this study we want of compare "Liquid Biopsy", defined by our blood and urine panel against prostate biopsy in a large-scale randomized manner including men referred for a biopsy due to the suspicion of prostate cancer over the age of 70 (elderly).
OBJECTIVE The primary objectives of this study are to test the ability of the "liquid biopsy" to
- Detect as many patients with aggressive prostate cancer as the standard method (PSA).
- Reduce the number of prostate biopsy sets taken and thereby reduce the number of patients detected with indolent prostate cancer.
The secondary objectives are to evaluate
- The economic effect of implementation of the test with regard to reduced biopsies taken, iatrogenic infectious disease and reduced control of indolent prostate cancer.
- The association of the liquid biopsy to tumor grade and tumor volume in biopsied men.
- The Quality of life.
- Progression and survival: overall survival, prostate cancer specific survival, PSA recurrence, time to metastases, time to castration resistance
- Safety
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mads H Poulsen, MD, PhD
- Phone Number: +45 2176 5418
- Email: mads.poulsen@rsyd.dk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Suspicion of prostate cancer due to elevated PSA, and/or palpable tumor in the prostate
- Indication for digital rectal examination and trans-rectal ultrasound with biopsy
- Age: 70 years or above
- PSA: 20 or above
- Able to provide informed written consent (competent adults only)
Exclusion Criteria:
- Previously diagnosed with prostate cancer
- Receiving treatment influencing PSA levels
- Medical conditions that may interfere with the study such as previously cancer-related therapy
- Life expectancy of less than 10 years
- MRI of the prostate within the last 2 years
- Digital rectal examination of the prostate within 24 hours or ejaculation within 24 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Liquid Biopsy
Experimental arm where the "liquid biopsy" decides whether to perform an prostate biopsy or not
|
Measuring biomarkers in blood and urine samples
|
OTHER: Standard Biopsy
Standard arm, where every patient receives a standard prostate biopsy
|
Histological examination of tissue biopsies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test sensitivity
Time Frame: 2 years
|
Number of detected patients with aggressive prostate cancer, defined as Gleason score ≥ 7.
|
2 years
|
Test specificity
Time Frame: 20 years
|
Number of patients who had prostate biopsies
|
20 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Lars Lund, MD, DMSci, Odense University Hospital
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DaProCa4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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