Prospective randomized analysis of psychological distress in men before, during, and after MR-fusion prostate biopsy depending on preoperative guidance

Not Applicable

Recruiting

• Conditions: C61; F41.3; Malignant neoplasm of prostate; Other mixed anxiety disorders

• Registration Number: DRKS00022361
• Lead Sponsor: niversitätsklinikum Bonn Klinik und Kinderklinik für Urologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

Subjects will only be included in the study if they meet all of the following criteria:
General inclusion criteria:
• Subjects: male, aged 45-85
• Clinical suspicion of prostate cancer and MR-fusion biopsy recommended to subject.
• Subject is able to follow the study instructions and likely to comply with all necessary study visits (compliance).
• Subject has given written consent to participate in the study.

Indication-specific inclusion criteria: none

Exclusion Criteria

Subjects will not be included in the study if any of the following criteria applies:
General Exclusion Criteria:
• Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
•Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
• Known or persistent abuse of medication, drugs or alcohol
• Contraindications for magnetic resonance imaging

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients suffering from perioperative mild, moderate and severe pain and anxiety depending on the preoperative given information

Secondary Outcome Measures

Name	Time	Method
• Percentage of patients with low self efficacy suffering from perioperative mild, moderate and severe pain and anxiety<br>• Percentage of patients with high perceived stress suffering from perioperative mild, moderate and severe pain and anxiety