NCT04393376

Brief Summary

The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

3.4 years

First QC Date

May 14, 2020

Last Update Submit

September 22, 2023

Conditions

Prostate CancerPSA

Keywords

Prostate CancerPSAGlycomics Assay

Outcome Measures

Primary Outcomes (1)

  • PSA Glycomics Assay

    The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients.

    1 year

Interventions

PSA Glycomics AssayDIAGNOSTIC_TEST

PSA Glycomics Assay will be performed on urine and blood samples

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with elevated PSA (\>3 ng/mL)
  • Signed informed consent

You may not qualify if:

  • Patients that have a cystitis (bladder infection)
  • Patients under chemotherapy
  • Patients using 5-alpha reductase inhibitors
  • History or presence of cancers, or non-prostate urological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

COMPLETED

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

RECRUITING

Leiden University Medical Centre

Leiden, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

J R Oddens, MD, PhD

CONTACT

+31(0)20-5668637j.r.oddens@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Urologist, Head of Department of Urology

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 19, 2020

Study Start

August 1, 2020

Primary Completion

January 1, 2024

Study Completion

August 1, 2025

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

NL(3)