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Prostatic Neoplasms

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Prostatic Diseases

Male Urogenital Diseases

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

Standard arm, where every patient receives a standard prostate biopsy

Measuring biomarkers in blood and urine samples

Liquid Biopsy

Histological examination of tissue biopsies

Standard biopsy

Mads H Poulsen, MD, PhD

Lars Lund, MD, DMSci

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.

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

We can only include persons born with a prostate.

Predicting Prostate Cancer in Elderly Men

Predicting Prostate Cancer Using a Panel of Plasma and Urine Biomarkers Combined in an Algorithm in Elderly Men Above 70 Years

Personal data is maintained in a safe database with logging and only anonymized data will be shared if needed.

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

Number of patients who had prostate biopsies

Odense University Hospital

MD, PhD, Associate professor

Targeted prostate biopsy

Transperineal ultrasound guided prostate biopsy(SB).

Hongqian Guo, PhD

Jie Gao, Bachelor

Jie Gao, MD

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mpMRI-targeted biopsy compared to transperineal standard biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).

With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-biopsy (SB).

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of TB compared to SB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection

Diagnostic Efficiency With Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Transperineal Ultrasound-guided Biopsy in Biopsy-naïve Suspicious Prostate Cancer Patients: A Randomized Controlled Trial

Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm.

Clinically insignificant prostate cancer is considered as: biopsy Gleason score \<3+4 and maximum cancer core length \<5 mm.

Comparing the Gleason grades (from 1-5, the bigger the worse) between biopsy and final pathology, Gleason grade is upgrading when the Gleason grade of final pathology is bigger than that of biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predicting Prostate Cancer in Elderly Men	NCT04079699	Prostate Cancer...	Liquid Biopsy Standard biopsy	70 Years -	Odense University Hospital
Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection	NCT03572946	Prostate Neopla...	Targeted prosta... Standard biopsy	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection	NCT03572946	Prostate Neopla...	Targeted prosta... Standard biopsy	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Predicting Prostate Cancer in Elderly Men	NCT04079699	Prostate Cancer...	Liquid Biopsy Standard biopsy	70 Years -	Odense University Hospital
Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection	NCT03572946	Prostate Neopla...	Targeted prosta... Standard biopsy	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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