NCT03256630

Brief Summary

A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the Presence or Absence of Aggressive Prostate Cancer

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

August 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

August 16, 2017

Last Update Submit

February 3, 2020

Conditions

Prostate Cancer

Keywords

Active SurveillanceRadical Prostatectomy

Outcome Measures

Primary Outcomes (1)

  • Characterize the distribution of clinical/pathological factors of the samples by the Gleason Grade Group and to characterize the distribution of the signal of each biomarker by the Gleason Grade Group or combination of groups.

    1 year

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostate cancer patients who are planning to have a Radical Prostatectomy at the Global Robotics Institute and are informed and willing to participate in study.

You may qualify if:

  • Patient has been diagnosed with Prostate Cancer and is planning on having a Radical Prostatectomy performed at the Global Robotics Institute.
  • Diagnostic PSA ≤ 20 ng/mL.
  • Pathology report from most recent positive biopsy, prior to Radical Prostatectomy, is available.
  • Ability to read and understand the informed consent form.
  • Patient must have signed informed consent form

You may not qualify if:

  • Any of the following active therapies received: radiation, chemotherapy, biologic agents, surgery, local therapies including cryotherapy or HIFU.
  • Diagnostic PSA \> 20 ng/mL or missing PSA.
  • Patients who are unable or unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital Global Robotics Institute

Celebration, Florida, 34747, United States

Location

Biospecimen

Blood, Urine

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 22, 2017

Study Start

January 10, 2018

Primary Completion

December 20, 2018

Study Completion

February 28, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

US(1)