Clinical trials: Clinically Significant Prostate Cancer
Prostate Cancer, Risk Assessment
PROstate Cancer Risk Calculator for ACTionable Clinical Decision-making in Nigeria
This study is a pilot trial that builds on findings from the validation of prostate cancer risk calculators in Nigerian men. The goal of the overall study is to improve the early detection of prostate cancer in a high-risk…
- Conditions
- Prostate Cancer, Risk Assessment, Clinical Decision Support Systems, Predictive Value of Tests
- Trial name
- PROACT (NCT07733440)
- Testing
- (a) Training and (b) Supported risk assessment
- Where
- Nigeria
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Ahmadu Bello University
Low Risk Prostate Cancer, Clinically Significant Prostate Cancer
Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET/CT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS).
- Trial name
- I-SELECT (NCT07168616)
- Testing
- Ga-68 PSMA11 PET/CT
- Where
- 10 sites in Turkey (Türkiye)
- Volunteers
- 201 people
- Sponsor
- Istanbul University - Cerrahpasa
Clinical Suspicion of Prostate Cancer
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).
- Trial name
- RF2021-1237227 (NCT06305390)
- Testing
- PET/MRI
- Where
- Italy
- Volunteers
- 167 people
- Sponsor
- IRCCS San Raffaele
Prostate Cancer
TULIP ReTrain Study
This prospective clinical study aims to retrain and validate the PCaVision AI algorithm for the detection and localization of clinically significant prostate cancer (csPCa) using multiparametric ultrasound (mpUS) with two…
- Trial name
- TULIP ReTrain (NCT06974539)
- Testing
- Multiparametric ultrasound with contrast (Sonovue and Optison)
- Where
- Netherlands
- Volunteers
- 212 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Prostate Cancer
Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy
This is a randomized controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-targeted approach (MRI-arm) versus 24-core transperineal (TP) systematic biopsy (TP-arm).
- Trial name
- SMART (NCT04685928)
- Testing
- MRI and MRI-guided prostate biopsy, TP-arm Systematic biopsy
- Where
- 8 sites in Hong Kong
- Volunteers
- 403 people
- Sponsor
- Chinese University of Hong Kong
Prostate Cancer - Recurrent, Prostate Cancer (Diagnosis)
Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated With HIFU
There would appear to be a strong interest in functional nuclear imaging for assessing the response to focal PaC treatment. Investigator team hypothesise that the diagnostic performance of PSMA PET is noninferior to that of MRI…
- Trial name
- ECETEP (NCT07766122)
- Testing
- Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Toulouse
Prostate Cancer
Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision
The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection…
- Trial name
- NCT06281769
- Testing
- 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision, MRI targeted biopsy pathway
- Where
- 5 sites in Netherlands
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Prostate Cancer
Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy
This study is designed as a randomized control trial which intends to determine if transperineal (TP) targeted biopsy is not inferior to transrectal (TR) targeted biopsy for diagnosis of clinically significant prostate cancer…
- Trial name
- NCT03936127
- Testing
- Ultrasound (US) Targeted Fusion Biopsy
- Where
- Canada
- Volunteers
- 360 people
- Sponsor
- Dr. Nicola Schieda
High-risk Prostate Cancer, PSMA PET
Serial PSMA PET for Therapy Monitoring in Clinically Significant Prostate Cancer
This prospective, multicenter study aims to evaluate the clinical utility of serial PSMA PET for therapy monitoring in patients with newly diagnosed clinically significant prostate cancer.
- Conditions
- High-risk Prostate Cancer, PSMA PET, Treatment Response, Therapy Monitoring
- Trial name
- PSMA-TM (NCT07553780)
- Where
- 9 sites in China
- Volunteers
- 110 people
- Sponsor
- Xijing Hospital
Prostate Cancer
Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
This trial aims to develop and validate the urinary multimarker sensor which can measure trace amounts of biomarkers from naturally voided urine in men referred with clinical suspicion of prostate cancer who have had no prior…
- Trial name
- NCT04825002
- Testing
- Urinary multimarker sensor
- Where
- South Korea
- Volunteers
- 800 people
- Sponsor
- Asan Medical Center
Prostate Cancer
Multiparametric Magnetic Resonance Imaging (mpMRI) Versus Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA-PET) for Detecting Clinically Significant Prostate Cancer in Transition Zone Lesions /PRostate Imaging With MRI and PET in the Transition Zone (PRIME-TZ)
This prospective, single-center diagnostic accuracy study will compare mpMRI and PSMA-PET for the detection of clinically significant prostate cancer in patients with prostate imaging reporting and data System (PI-RADS) ≥4…
- Trial name
- PRIME-TZ (NCT07892378)
- Testing
- Multiparametric Magnetic Resonance Imaging (mpMRI), 18F-PSMA-1007 PET, Prostate Biopsy
- Where
- Argentina
- Volunteers
- 65 people
- Sponsor
- Sanatorio Privado San Geronimo
Prostate Cancer
Validation of a Machine Learning Model Based on MR for the Prediction of Prostate Cancer
The goal of this observational study is to validate a clinically significant predictive machine learning model based on the processing of images RMmp (Multiparametric Magnetic Resonance Imaging).
- Trial name
- NCT06773598
- Where
- Italy
- Volunteers
- 1,100 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Prostate Carcinoma
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer
This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL.
- Trial name
- NCT04910425
- Testing
- Fluorine F 18 DCFPyL, Gadobenate Dimeglumine, Gadobutrol
- Where
- United States
- Sponsor
- Northwestern University
Prostate Cancer, Clinically Significant Prostate Cancer
Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy
This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance…
- Conditions
- Prostate Cancer, Clinically Significant Prostate Cancer, Cognitive Fusion
- Trial name
- PROCOG (NCT07710807)
- Testing
- Transrectal Cognitive Fusion Prostate Biopsy, Transperineal Cognitive Fusion Prostate Biopsy
- Where
- Turkey (Türkiye)
- Volunteers
- 280 people
- Sponsor
- Ankara Etlik City Hospital
Prostate CA
Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management
Prostate cancer is the most common male cancer in 112 countries and makes up 7% of global cancer cases, and is the second leading cause of cancer-related deaths in men.
- Trial name
- PARADIGM (NCT07647445)
- Testing
- AI (Lucida Pi) interpretation, Radiologist interpretation
- Volunteers
- 500 people
- Sponsor
- University College, London
Prostate Cancer
Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
In recent years, new and promising approaches have emerged in the field of MRI imaging of the prostate. These approaches usually aim to visualise the so-called "microstructures" of the tissue and are intended to offer greater…
- Trial name
- NCT07432360
- Where
- Brazil
- Volunteers
- 300 people
- Sponsor
- Virdx, Inc.
Prostate Cancer
A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen)
A population-based randomised trial of prostate cancer screening will be carried out. A total of approximately 117,200 men aged 50-63 in Helsinki and Tampere are randomised to intervention (screening) or control arm.
- Trial name
- ProScreen (NCT03423303)
- Testing
- Prostate cancer screening
- Where
- 2 sites in Finland
- Volunteers
- 17,400 people, healthy volunteers welcome
- Sponsor
- Tampere University
Prostate Cancer, Prostate Cancer Screening
Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer
This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy…
- Conditions
- Prostate Cancer, Prostate Cancer Screening, Performance Assessment of Novel Test
- Trial name
- APCaRI-05 (NCT03957252)
- Where
- 3 sites in United States, Canada
- Volunteers
- 2,800 people
- Sponsor
- Nanostics
Prostate Cancer
Artificial Intelligence Software (Prostate Intelligence) for Detecting Clinically Significant Prostate Cancer on MRI
The goal of this study is to learn how accurately an artificial intelligence (AI) software called Prostate Intelligence (Pi) detects clinically significant prostate cancer on prostate MRI in adults with a prostate gland who are…
- Trial name
- RADAR (NCT07875491)
- Testing
- AI-based prostate MRI analysis software
- Where
- Italy
- Volunteers
- 226 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Randomized Controlled Trial, Prostate Cancer
Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy
3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial.
- Conditions
- Randomized Controlled Trial, Prostate Cancer, Magnetic Resonance Imaging
- Trial name
- NCT06402552
- Testing
- bp-MRI prostate, mp-MRI prostate
- Where
- Taiwan
- Volunteers
- 370 people
- Sponsor
- Chang Gung Memorial Hospital