NCT05317143

Brief Summary

Pathological assessment of prostate tissue

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 2, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

February 2, 2022

Last Update Submit

April 7, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Positive Margin

    Detection of positive margin

    Immediately postoperatively, expected same day as surgery

Interventions

Evaluation of prostate cancer marginsOTHER

Evaluation of prostate cancer margins

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with prostate cancer who undergo robotic-assisted prostatectomy

You may qualify if:

  • Diagnosed with prostate cancer
  • Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Antonius Hospital, Prostatazentrum Nordwest

Gronau, 48599, Germany

Location

Biospecimen

Retention: NONE RETAINED

Prostate

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jörn Hinrich Witt, PD Dr. med

    St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany

    PRINCIPAL INVESTIGATOR

  • Sami-Ramzi Leyh-Bannurah, PD Dr. med

    St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 2, 2022

First Posted

April 7, 2022

Study Start

February 22, 2022

Primary Completion

November 10, 2022

Study Completion

November 10, 2022

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)