Predicting Prostate Cancer in Elderly Men

NCT04079699 | Not Yet Recruiting DMC

• 1 other identifier: DaProCa4
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Prostate Cancer (Diagnosis)

Outcome Measures

Primary Outcomes (2)

• Test sensitivity

  Number of detected patients with aggressive prostate cancer, defined as Gleason score ≥ 7.

  2 years

• Test specificity

  Number of patients who had prostate biopsies

  20 years

Study Arms (2)

Liquid Biopsy

EXPERIMENTAL

Experimental arm where the "liquid biopsy" decides whether to perform an prostate biopsy or not

Diagnostic Test: Liquid Biopsy

Standard Biopsy

OTHER

Standard arm, where every patient receives a standard prostate biopsy

Diagnostic Test: Standard biopsy

Interventions

Liquid Biopsy DIAGNOSTIC_TEST

Measuring biomarkers in blood and urine samples

Liquid Biopsy

Standard biopsy DIAGNOSTIC_TEST

Histological examination of tissue biopsies

Standard Biopsy

Eligibility Criteria

• Age: 70 Years+
• Gender Eligibility Details: We can only include persons born with a prostate.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Lars Lund, MD, DMSci

  Odense University Hospital

  STUDY DIRECTOR

Central Study Contacts

Mads H Poulsen, MD, PhD

CONTACT

+45 2176 5418; mads.poulsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate professor

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion (Estimated): October 1, 2039
• Study Completion (Estimated): October 1, 2039
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share