Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04079699
Other study ID # DaProCa4
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date October 1, 2039

Study information

Verified date September 2019
Source Odense University Hospital
Contact Mads H Poulsen, MD, PhD
Phone +45 2176 5418
Email mads.poulsen@rsyd.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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

Study Design


Intervention

Diagnostic Test:
Liquid Biopsy
Measuring biomarkers in blood and urine samples
Standard biopsy
Histological examination of tissue biopsies

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Outcome

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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04803188 - Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I N/A
Completed NCT04091230 - New Biopsy Needle - Evaluation of Prostate Biopsy Quality N/A
Recruiting NCT03507595 - Evaluation of the Metastasis and Recurrence of Prostate Cancer
Recruiting NCT04880681 - Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle N/A
Completed NCT04583072 - Stockholm3 Validation Study in a Multi-Ethnic Cohort