NCT05572099

Brief Summary

The goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.

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
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 5, 2022

Last Update Submit

October 5, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Develop and evaluate risk-based scoring using the ExoDx Prostate test.

    1yr after last enrolled patient

Interventions

ExoDx ProstateDIAGNOSTIC_TEST

Observational only.

Eligibility Criteria

Age45 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHave a prostate
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

You may qualify if:

  • Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

You may not qualify if:

  • Clinical symptoms of urinary tract infection at time of enrollment.
  • History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment.
  • Known hepatitis or HIV
  • History of concurrent renal/bladder tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chesapeake Urology

Towson, Maryland, 21204, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine specimens

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sonia Kumar, PhD

    Exosome Diagnostics, Inc.

    STUDY DIRECTOR

Central Study Contacts

Sonia Kumar, PhD

CONTACT

6175880500Sonia.Kumar@bio-techne.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 7, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations

US(1)