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Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 75 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A minimum of 10 cores is required if a systematic biopsy is performed."
  • "Histopathological examination of the biopsy specimen will be performed according to the established local practice."
  • "A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks how well the Proclarix blood test finds the risk of prostate cancer that may need treatment. It is for men ages 40–75 with a PSA blood test level of 2–10 ng/mL who are discussing a possible prostate biopsy, a test that takes small tissue samples.

The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. If a prostate biopsy is performed, it will be performed according to standard clinical practice of the urologist (systematic, targeted, or combined biopsy with a transrectal or transperineal approach with or without prior magnetic resonance imaging (MRI)). A minimum of 10 cores is required if a systematic biopsy is performed. Histopathological examination of the biopsy specimen will be performed according to the established local practice. A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are male and 40–75 years old.
  • You sign and date a form agreeing to join the study.
  • Your routine total PSA level is 2–10 ng/mL, tested within 90 days before the study blood draw. PSA is a protein measured in blood.
  • You are visiting the clinic to discuss a possible prostate biopsy.
  • You agree to share all test results used to check your condition during the study.
  • You agree to give blood for Proclarix and phi testing at the screening visit.
  • Your study blood is drawn before any study MRI scan or prostate biopsy.

Who can't join

  • You have been diagnosed with prostate cancer before.
  • You took a 5-alpha-reductase inhibitor, a type of medicine used for an enlarged prostate or hair loss, within 6 months before the blood draw.
  • You had a urinary tract infection within 3 months before the blood draw.
  • You had a catheter left in place or used one yourself to drain urine within 30 days before the blood draw.
  • You had a rectal prostate exam or a procedure through the urine tube, such as a bladder scope or catheter placement, earlier on the day of the blood draw.
  • You had a prostate biopsy or an invasive procedure to treat a noncancerous enlarged or blocked prostate within 6 months before the blood draw.
  • You cannot read or understand the consent form, or you joined this study before and had valid biopsy results.
  • You had a prostate MRI scan within 90 days before the blood draw.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (7)

CA

ID

KY

MD

NY

SC