Status:
NOT_YET_RECRUITING
Predicting Prostate Cancer in Elderly Men
Lead Sponsor:
Odense University Hospital
Conditions:
Prostate Cancer (Diagnosis)
Eligibility:
MALE
70+ years
Phase:
NA
Brief Summary
We aim to analyze whether the "liquid biopsy" model could increase the specificity of detecting men with an aggressive (defined as Gleason score ≥ 7) prostate cancer and thereby reduce the proportion ...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2039
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04079699
Start Date
October 1 2019
End Date
October 1 2039
Last Update
September 6 2019
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