Prostate Cancer (Diagnosis) Clinical Trial
Official title:
Predicting Prostate Cancer Using a Panel of Plasma and Urine Biomarkers Combined in an Algorithm in Elderly Men Above 70 Years
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 of men who undergo prostate biopsy, while at the same time maintaining the same sensitivity to detect aggressive prostate cancer as the PSA test alone. Using blood and urine biomarkers together with an algorithm, which incorporates the clinical data, we aim to identify patients who have a high risk of having an aggressive prostate cancer. By performing this non-invasive test we expect that we can reduce need for prostate biopsy and reduce the detection of patients with an indolent prostate cancer (defined by Gleason score ≤ 6). Thereby we aim to reduce the side effects of transrectal ultrasound guided biopsy of the prostate and side-effects of living with an indolent cancer.
Status | Not yet recruiting |
Enrollment | 700 |
Est. completion date | October 1, 2039 |
Est. primary completion date | October 1, 2039 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 70 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Odense University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test sensitivity | Number of detected patients with aggressive prostate cancer, defined as Gleason score = 7. | 2 years | |
Primary | Test specificity | Number of patients who had prostate biopsies | 20 years |
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