Predicting Prostate Cancer in Elderly Men

NCT ID: NCT04079699

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2039-10-01

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.

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

1. Detect as many patients with aggressive prostate cancer as the standard method (PSA).

2. 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

1. The economic effect of implementation of the test with regard to reduced biopsies taken, iatrogenic infectious disease and reduced control of indolent prostate cancer.

2. The association of the liquid biopsy to tumor grade and tumor volume in biopsied men.

3. The Quality of life.

4. Progression and survival: overall survival, prostate cancer specific survival, PSA recurrence, time to metastases, time to castration resistance

5. Safety

Conditions

Prostate Cancer (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Liquid Biopsy

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

Group Type: EXPERIMENTAL

Liquid Biopsy

Intervention Type: DIAGNOSTIC_TEST

Measuring biomarkers in blood and urine samples

Standard Biopsy

Standard arm, where every patient receives a standard prostate biopsy

Group Type: OTHER

Standard biopsy

Intervention Type: DIAGNOSTIC_TEST

Histological examination of tissue biopsies

Interventions

Liquid Biopsy

Measuring biomarkers in blood and urine samples

Intervention Type: DIAGNOSTIC_TEST

Standard biopsy

Histological examination of tissue biopsies

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mads Hvid Poulsen

MD, PhD, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Lund, MD, DMSci

Role: STUDY_DIRECTOR

Odense University Hospital

Central Contacts

Mads H Poulsen, MD, PhD

Role: CONTACT

mads.poulsen@rsyd.dk

+45 2176 5418

Other Identifiers

DaProCa4

Identifier Type: -

Identifier Source: org_study_id