Proclarix blood test to identify clinically significant prostate cancer in a multi-ethnic US cohort

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, single-cohort US validation in up to 10 urology clinics where blood is collected before a scheduled prostate biopsy and analyzed with the Proclarix assay at Labcorp. Proclarix combines two protein biomarkers (THBS1 and CTSD) with total and free PSA and age to produce a risk score, and the lab samples are blinded to biopsy outcome. Biopsies are performed per local standard practice (systematic, targeted, or combined, transrectal or transperineal) with at least 10 cores and histopathology read locally; clinically significant prostate cancer (csPCa) is ISUP Grade Group ≥2. The study will compare Proclarix risk scores to biopsy results to validate performance in a multi-ethnic US population, building on previous European validations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is male ≥40 and ≤75 years of age at the time of enrollment;
2. Subject provides a signed and dated informed consent;
3. Subject has a SOC tPSA of 2-10 ng/mL inclusive within 90 days of the study blood draw;
4. Subject is presenting to the clinic to discuss a potential prostate biopsy;
5. Subject agrees to provide all diagnostic test results throughout the study; and
6. Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit.

7 Study blood sample will be collected prior to MRI (if conducted) and prior to the biopsy.

Exclusion Criteria

1. Previous diagnosis of prostate cancer;
2. Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood collection;
3. Acute or chronic urinary tract infection within 3 months of the study blood collection;
4. Men with an indwelling catheter or intermittent self-catheterization within 30 days of the study blood collection;
5. Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the study blood collection;
6. Men who had an invasive urological procedure for benign prostate hyperplasia/obstruction (e.g. transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), Thulium laser enucleation of the prostate (ThuLEP), aquablation, prostatic artery embolization, Rezum, laser vaporization, etc.) or biopsy of the prostate within 6 months prior to the study blood collection;
7. Subject is not able to read or comprehend the informed consent form;
8. Previous enrollment in this protocol with valid biopsy results; or
9. Men who had an MRI of the prostate within 90 days prior to the study blood collection.

Where it's running

• Om Research
  San Diego, California, United States Recruiting
• Idaho Urologic Institute
  Meridian, Idaho, United States Recruiting
• Graves Gilbert Clinic
  Bowling Green, Kentucky, United States Recruiting
• Chesapeake Urology Associates
  Hanover, Maryland, United States Recruiting
• Chesapeake Urology Associates
  Towson, Maryland, United States Recruiting
• Crystal Run Healthcare
  Middletown, New York, United States Recruiting

Study contacts

• Principal investigator: Neil Shore, MD — Carolina Urologic Research Center
• Study coordinator: Senior Clinical Trial Manager
• Email: clinicalaffairsSD@labcorp.com
• Phone: 858-202-2000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

• Methylscape test in body fluids for multi-cancer detection in Colombia

  A simple blood, urine, or saliva test called Methylscape is being tested to see if it can detect multiple cancers and identify where the signal is coming from, using people with cancer and healthy volunteers in Colombia.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07741435

• Empowering patients to get lung cancer screening with support and navigation

  This pilot study tests a patient navigation and education program to see if it helps adults who are eligible start and complete low-dose CT lung cancer screening.

  Recruiting at 13 sites University of California, Irvine · Anaheim, California and 56 other locations · NCT07711691

• Breast ultrasound screening for older women in community clinics

  This study tests whether offering breast ultrasound to women aged 65–80 in local communities helps find breast cancers earlier than usual care.

  Recruiting The First Affiliated Hospital with Nanjing Medical University · Kunshan, Jiangsu and 1 other locations · NCT07698366

• Text reminders to boost colorectal cancer screening participation

  A large group of people aged 50–69 in Vallès Occidental will be randomised to receive a reminder text message five weeks after an initial invitation, to see if it increases uptake of the FIT screening compared with the standard postal letter.

  Recruiting Corporacion Parc Tauli · Sabadell, Catalonia · NCT07628998

• Menstrual cup for early detection of endometrial cancer in Lynch syndrome

  This project will test whether using a menstrual cup can collect uterine lining samples that help detect early endometrial cancer in menstruating people who carry Lynch syndrome gene changes.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07220239

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.