Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Urogenital Neoplasms

Prostatic Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.

Standard tru cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000).

Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.

Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)

Andreas Forsvall

Adam Linder, Ass prof

Andreas Forsvall, MD

Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.

Prostate biopsy is the golden standard for prostate cancer diagnosis. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. The biopsy chamber of the Tru Cut needle is in general 19 mm. However, it is on average filled only with 13 mm of tissue. Biopsy length is strongly correlated with diagnostic accuracy of prostate cancer.

Additionally, TRUSbx has a high risk of infection due to bacteria being brought across the colon wall. The investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (NCT049091230) has shown non inferior biopsy length when compared to the standard Tru Cut needle. A further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. This is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard Tru Cut biopsy needle in prostate biopsy.

60 patients eligible for prostate biopsy are randomized into 2 arms (30+30 patients) using either the novel needle and actuator device or standard Tru Cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy length (primary outcome) is evaluated by a pathologist who is blinded to device used.

Patient and pathologist are unaware of which needle/device is used. All biopsies are taken from behind the back of the patient enabling masking from the patient. To assess masking success, patients will be asked to guess which device was used after the procedure is complete.

Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle

Numeric rating Pain Scale rating from 0-10

Any complications related to the biopsy (example infection, bleeding)

The number of sections the biopsy specimen is made of

General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)

Region Skane

Herbal and Botanical

All Drugs and Chemicals

English Lavender

Self-identified as White Non-Hispanic men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer

Self-identified as African or Black men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer

Self-identified as White Hispanic men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer

Self-identified as Asian men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer

Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 ml tubes will be removed after obtaining consent from the subjects.

The Stockholm3 test

Henrik Grönberg, MD, PhD

Introduction: Prostate cancer (PCa) is the most commonly detected cancer in men and is the second leading cause of cancer death. Differences in race and ethnicity have been shown to have differences in PCa incidence, detection, and outcomes. Current prostate cancer screening involves prostatic specific antigen (PSA) which is a nonspecific protein marker (aka kallikrein) that can often leads to unnecessary biopsies (up to 74% benign biopsies) and clinical overdiagnosis (with up to 22% clinically insignificant cancer). Recently more sophisticated tests have been developed for PCa screening in the United States such as the Prostate Health Index (PHI) and the 4k (kallikrein) score, as well as clinical models that use information from the patient clinical history. However, these tests utilize limited serum protein assays and none of the established screening protocols utilize genetic variables to help account for the likely inherited risks as seen in different ethnicities.

A recent Swedish, prospective, population-based study, published in the Lancet Oncology, developed a unique multivariable biopsy outcome prediction model within a Nordic population of nearly 60,000 men. This model, the Stockholm3, which incorporated plasma protein markers, germline DNA SNPs as well as clinical variables, was shown to be capable of reducing the number of biopsies by 44% compared to PSA while maintaining adequate sensitivity for detection of PCa.

It is unknown whether an approach developed in Sweden that incorporates protein markers, genetics, clinical variables, and genetic ancestry would be beneficial in a racially diverse cohort.

Hypothesis: The investigators hypothesize that, a prospectively studied multiethnic cohort of men with the Stockholm3 test will identify unique and common risk factors that improve prostate cancer detection.

Aim: To assess the performance of the Stockholm3 test as compared to PSA and to identify unique features associated with PCa in Black/African American (n=500), Asian (n=500), White/Caucasian Hispanic (n=500), and White/Caucasian Non-Hispanic (n=500) men.

Methods: The investigators propose a prospectively identified cohort with participating institutions which have screened positive to undergo a prostate biopsy to have a retrospective analysis the Stockholm3 test and ancestry markers. Within this cohort the investigators will examine several predetermined risk factors to investigate their relationship to prostate cancer.

This blood sample will be tested for quantitative levels of serum protein markers and DNA will be extracted and will be tested for germline mutations as defined by the Stockholm3 test and other ancestry informative markers. Results from the study will be presented in such a way that no individual information will be disclosed.

Study Design and Procedures:

The research coordinator will explain the information contained within the consent. Additionally, patient's blood will be drawn prior to their biopsy.

Prior to the biopsy, blood will be collected in x2 ethylenediaminetetraacetic acid (EDTA) 4 ml tubes after obtaining consent from the subjects. One tube will be immediately centrifuged (10 minutes at 2000G) and plasma decanted to a tube without additives (this typically produces 1.5 ml of plasma). The decanted tube (with plasma) and the remaining EDTA tube (with whole blood) is then frozen and stored at the designated participating institutional site. It will be stored at -20 Celsius until being shipped. The SEPTA specific blood collection is followed by the following collaborators: Uropartners, University of Illinois at Chicago, University of Chicago, Rush Medical Center, Montefiore, University of Texas Health Science Center of San Antonio, Urology Clinics of North Texas, University of Southern California Keck School of Medicine, Los Angeles County Hospital, Stanford University.

Additional samples from University Health Network (Toronto), Northwestern Medicine, John H. Stroger, Jr. Hospital of Cook County, and Cook County Health System (Chicago) will be included from biobanked sources which were prospective collected meeting inclusion and exclusion criteria.

Patient data will be stored in a REDCap database, hosted on Sweden's secure server. Data will be stored for the duration of the study, and 5 years afterwards for data analysis purposes.

Consented patients will be tracked by patient logs by each participating institution. The medical record number will be collected to keep a consistent identifier for data collection by key site personnel. Once all the patient data is recorded the data will be exported from REDCap with the MRN removed. There will be no patient identifiers used at the Karolinska Institute or A3P lab. The following PHI and non-PHI information will be logged of the patient:

PHI:

Medical record number (MRN)

Non-PHI Demographic data

* Stockholm3 Identification number
* Race
* Zip code

Clinical data

* Total PSA
* Age on sampling date \[years\]
* Family history of prostate cancer
* Use of 5-alpha reductase inhibitors
* Earlier biopsy conducted
* Prostate volume \[Prostate volume as measure with US\]
* Digital rectal exam status \[Benign/normal, Nodule/induration felt, Asymmetry, Not performed\]

AND

Outcome data - Results from biopsy performed immediately after blood venipuncture, i.e.:

Results will be separated into targeted biopsy cores and systematic biopsy cores

* Gleason Score 1
* Gleason Score 2
* Gleason Sum
* Cancer length (mm) (total and highest grade)
* Number of cores
* Number of positive cores
* Time to perform biopsy after blood draw \[days\]
* Results from MRI, i.e. Prostate Imaging Reporting \& Data System (PIRADS) (0, 1, 2, 3, 4, 5)

Permitted use:

To run the Stockholm3 test defined by Gronberg et al AND Ancestry informative genetic markers

Samples will be shipped to the Uppsala based laboratory (A23 Laboratory) in Sweden for analysis. Each patient will have two blood samples (plasma and whole blood) and will be frozen at -20 Celsius. The blood samples will then be tested for quantitative levels of serum protein levels and DNA will be extracted from white blood cells and will be tested for gene and small nucleotide polymorphic (SNPs) germline mutations and variants .

Genotyping will be performed using custom genotyping assays. Plasma will be used for protein analysis. Plasma protein analysis will be performed using a custom protein assays including total and free PSA, human glandular kallikrein 2 (hK2), microseminoprotein-beta (MSMB), and Macrophage inhibitory cytokine 1 (MIC-1). PSA will be tested with a commercial assay.

Based on the results from the plasma protein analysis, the genetic analysis and clinical data, the Stockholm3 Risk Score will be calculated. The participants' samples will be treated in accordance with the regulations of Sweden at the laboratory based in Uppsala, Sweden.

Results of the tests will not be shared with the patient, nor will the results change or impact medical decisions.

Expected Risks/Benefits

Anticipated Risks:

As this is retrospective analysis of deidentified patient information as well as deidentified biospecimens, there are few anticipated risks. A confidentiality breach as well as loss of privacy are possible, however every effort will be made to minimize this risk.

Anticipated Benefits:

Participants will advance scientific and clinical knowledge. Participants will also receive a small payment for the time and involvement in the study.

Data Collection and Management Procedures

This study will utilize REDCap (Research Electronic Data Capture), a software toolset and workflow methodology for electronic collection and management of clinical and research data, to collect and store data. The Karolinska Institute Information Technology (KI-IT) Department will be used as a central location for data processing and management. REDCap is hosted by KI-IT in the Biomedicum (Solnavägen 9, Solna, Sweden 17165)

Data Analysis

Data analysis will be performed by the PI, co-investigators and/or key research personnel.

Quality Control and Quality Assurance

Key research personnel will be responsible for ensuring all data collected adheres to the protocol.

Data and Safety Monitoring

This study is minimal risk and all efforts will be made to ensure there are no confidentiality breaches as well as no loss of privacy.

Statistical Considerations

Power analysis This study is being conducted among several sites and thus pooled analysis will be performed. Based on the framework developed a two-sided alpha of 0.05, 250 men in each ethnicity gives 80% power to detect 10 percentage points differences in sensitivity and/or specificity of the Stockholm3 test across different ethnicities. Pooled data from several sites will allow for comparison between non-Hispanic White, Africa/Black, Asian, and Hispanic White men. Within each ethnicity group of 250 men, the same sample size gives a 90% power for detecting differences in area under curve (AUC) between Stockholm3 and PSA for detection of PC that are at least 10 percentage points (primary aim).

Goal accruement is 500 men within each race/ethnicity, interim analysis will be performed when 250 men in each race/ethnicity is enrolled.

Data Analysis Descriptive univariate statistics will be used to compare groups. Binary endpoints will be assessed with a logistic regression model. Statistical analysis will involve logistic regression modeling, AUC calculation, calibration analyses and calculation of basic performance characteristics (sensitivity, specificity and predictive values).

Regulatory Requirements

Informed Consent The participants indicate their consent to participate in the study by signing informed consents for accessing medical records, conducting genetic research and undergoing venipuncture for blood samples.

Subject Confidentiality Data used for this study will be stored in REDCaps and all data transferred between institutions will remain deidentified throughout the study.

Unanticipated Problems Any unanticipated problems will be immediately reported to the Site-specific ethical review board by designated research personnel.

Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 milliliters (8 milliliters total) tubes will be removed after obtaining consent from the subjects. One tube will be immediately centrifuged (10 minutes at 2000G) and plasma decanted to a tube without additives (this typically produces approximately 1.5 milliliters of plasma). The decanted tube (with plasma) and the remaining EDTA tube (with whole blood) is then frozen and stored at -20 degrees Celsius until being shipped to the A3P lab for Stockholm3 testing and analysis at -20 degrees Celsius (unless processing for DNA extraction and plasma analysis).

Other biobanked specimens (as described in the Study detailed description) will be collected prospectively and will include plasma and Buffy Coat (used for DNA extraction) utilising the study inclusion and exclusion criteria.

Stockholm3 Validation Study in a Multi-Ethnic Cohort

SEPTA Trial: Stockholm3 Validation Study in a Multi-Ethnic Cohort for ProsTAte Cancer

International Society of Urological Pathology Gleason Grade Group 2 Prostate Cancer. Gleason Grade Group scale is used to grade prostate cancer if found on a scale from 1 to 5. A higher score means a worse outcome.

National Comprehensive Cancer Network Unfavorable intermediate risk prostate cancer or higher risk. National Comprehensive Cancer Network risk stratification scores range from very low risk, low risk, intermediate risk, high risk and very high risk. Intermediate risk is stratified into favorable intermediate risk and unfavorable intermediate risk. The higher the risk the worse the outcome

University of Illinois at Chicago

UroPartners

University of Chicago

Rush University Medical Center

Montefiore Medical Center

The University of Texas Health Science Center at San Antonio

Cook County Health & Hospitals System

Cook County Health

Stanford University

Northwestern Medicine

University of Southern California

University Health Network, Toronto

Urology Clinics of North Texas

LAC+USC Medical Center

Karolinska Institutet

Professor

TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient.

TRUSbx using a standard tru cut biopsy needle (Mermaid Medical M-biopsy 18G 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator ( Moller Medical Blue RBG-1000-10-1000). 12 biopsies/ patient.

Trans Rectal UltraSound guided Prostate Biopsy

TRUSbx

Adam Linder, MD, PhD

Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.

Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance.

The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today.

This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.

20 patients eligible for prostate biopsy are randomized into 2 arms (10+10 patients) using either the novel needle and actuator device or standard tru cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy quality is evaluated by the pathologist blinded to device used.

Patient and pathologist are unaware of which needle/device is used. TRUSbx are taken from behind the back of the patient enabling masking from the patient.

New Biopsy Needle - Evaluation of Prostate Biopsy Quality

Prospective Patient Blinded Randomized Trial Comparing Biopsy Specimen Quality in a Novel Biopsy Needle and Actuator Compared to Todays Standard Tru Cut Needle and Actuator.

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

Symptoms and General Pathology

Neoplasm Metastasis

A: 355 patients will perform non-contrast MRI regardless their serum PSA value

B: 355 patients will perform non-contrast MRI when serum PSA value is increased (\>4 ng/ml or 2.5 ng/ml if positive family history)

Screening MRI examinations will be performed on an MRI General Electric (GE) 3 Tesla MRI using a 32-channel phased array pelvic coil. The imaging protocol will include: T2-weighted morphological and diffusion-weighted functional sequences.

All images will be reviewed by two radiologists experienced in urogenital imaging, who will be blinded to the patients' medical history. Both radiologists in charge will then assign a PI-RADS score (1 to 5) to each lesion for bi-parametric MRI, representing the likelihood of a clinically significant prostate lesion. For the generation of the overall PI-RADS score assigned to each lesion, the PI-RADS score algorithm for non-contrast MRI described in the PI-RADS version 2.1 recommendations will be applied. Lesions scored as bPI-RADS superior or equal than 3 will be directed to MRI-TRUS guided targeted biopsy.

Magnetic Resonance

Valeria Panebianco, MD

Prostate Cancer (PCa) screening is still a controversial topic in the urology community, this is mostly linked to the low specificity of Prostate Specific Antigen (PSA) value. Screening with total PSA value has cause overdiagnosis of clinically insignificant prostate cancer (ciPCa) for many years, with lack of survival improvement. Non-contrast MRI, on the other hand, has become one of the most promising MRI applications, as it is a more sensitive test able to perform clinically significant PCa early detection. With this background the primary endpoint was to investigate the role of non-contrast MRI (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test, in a randomized fashion.

ENDPOINTS Primary endpoint To investigate the role of non-contrast Magnetic Resonance Imaging (MRI), as a secondary prevention test for the early diagnosis of prostate cancer (PCa), comparing it with the serum PSA test.

Secondary endpoints

1. Assess the percentage of men with a positive PSA screening test, defined as \> 4 ng/ml and \> 2.5 ng/ml in patients with family history of PCa (father and/or sibling).
2. Evaluation of the percentage of men with positive MRI and MRI targeted biopsy results stratified according to: absence of neoplasm, non-clinically significant neoplasm (ISUP 1) and clinically significant neoplasm (ISUP\> 1), compared with PSA test and serum biomarkers (optional).
3. Comparison of the percentages of participants with PCa and with clinically significant PCa, according to the different positive screening tests.
4. Comparison of the different screening tests combinations in terms of PCa detection rate, both for non-clinically significant and clinically significant cancer.

STUDY DESIGN

Design:

Single center, prospective, interventional randomized controlled trial Duration: 2 years Evaluation of the effectiveness of the primary outcome: the evaluation of the effectiveness non-contrast MRI for the PCa detection will be based on MRI-guided biopsy targeted on the areas described and classified as biparametric Prostate Imaging-Reporting and Data System (bPI-RADS) ≥3 (scored according to the biparametric evaluation).

The reference standard for the diagnosis of prostate cancer will be the Magnetic Resonance Imaging - Transrectal Ultrasound (MRI-TRUS) guided targeted biopsy, which will be performed at a maximum of 4 weeks from MRI.

In order to evaluate the diagnostic accuracy of non-contrast MRI the diagnostic performance variables (sensitivity, specificity, accuracy, positive and negative predictive value, area under the curve and receiver operating characteristic curves) will be calculated.

For the statistical analysis of the effectiveness, only those participants who have undergone prostate biopsy as planned by the operator will be included.

In addition, the interreader agreement between two radiologists responsible for the analysis of MRI images, with 10 and 8 years of experience in urogenital imaging, respectively, will be evaluated. The agreement between the two radiologists will be calculated using the weighted Cohen's k statistic.

Evaluation of secondary outcomes: the evaluation of the effectiveness of secondary outcomes will be verified by evaluating the same statistical variables of diagnostic accuracy implemented for the primary purpose.

Safety evaluation: the safety of the procedure will be determined by assessing the incidence and severity of adverse events, defined as complications related to the procedure recorded from the first treatment and during the entire duration of the follow-up (2 years).

Participants in the study:

Enrollment: 710 men will be enrolled and blindly randomized in two different arms. Arm a) 355 patients will perform MRI with a bi-parametric approach (without contrast medium) regardless their PSA value; Arm b) 355 patients will perform MRI with a bi-parametric approach (without contrast medium) only when PSA is elevated.

Patients with positive MRI defined as bPI-RADS ≥3, will undergo MRI-directed targeted prostate biopsy.

Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I

A Randomized Controlled Trial on the Role of Magnetic Resonance Imaging for Prostate Cancer Screening

all individual participant data that underlie results in a publication

To evaluate the percentage of men with positive non-contrast MRI stratified according to: absence of neoplasm, non-clinically significant neoplasm (ISUP 1) and clinically significant neoplasm (ISUP\> 1), compared with the tests of the PSA and serum biomarkers (optional).

Comparison of the percentages of participants with the different positive screening tests. Comparison of the same in the subpopulation of patients with clinically significant neoplasia (ISUP\> 1).

Comparison of the different combination of screening tests in terms of detection rate, non-clinically significant and clinically significant cancer detection rate.

To investigate the role of MRI with a bi-parametric approach (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test.

To assess the percentage of men with a positive PSA screening test, defined as \> 4 ng/ml and \> 2.5 ng/ml in patients with family history of prostate cancer (father and/or sibling).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle	NCT04880681	Prostate Cancer...	Novel needle (1... Standard Tru Cu...	40 Years -	Region Skane
Stockholm3 Validation Study in a Multi-Ethnic Cohort	NCT04583072	Prostate Cancer...	The Stockholm3 ...	45 Years - 75 Years	Karolinska Institutet
New Biopsy Needle - Evaluation of Prostate Biopsy Quality	NCT04091230	Prostate Cancer...	TRUSbx	40 Years - 90 Years	Region Skane
Predicting Prostate Cancer in Elderly Men	NCT04079699	Prostate Cancer...	Liquid Biopsy Standard biopsy	70 Years -	Odense University Hospital
Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I	NCT04803188	Prostate Cancer...	Magnetic Resona...	40 Years - 69 Years	University of Roma La Sapienza
Stockholm3 Validation Study in a Multi-Ethnic Cohort	NCT04583072	Prostate Cancer...	The Stockholm3 ...	45 Years - 75 Years	Karolinska Institutet
Predicting Prostate Cancer in Elderly Men	NCT04079699	Prostate Cancer...	Liquid Biopsy Standard biopsy	70 Years -	Odense University Hospital
Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle	NCT04880681	Prostate Cancer...	Novel needle (1... Standard Tru Cu...	40 Years -	Region Skane

Spots Global Cancer Trial Database for prostate cancer (diagnosis)