Establishment of a prehabilitation process for patients with prostate cancer prior to curatively intended radical prostatectomy - an exploratory, prospective, controlled intervention study.

Not Applicable

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00031854
• Lead Sponsor: Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 252

Inclusion Criteria

Patients who meet the following criteria may be included in the study:
•Patients are between = 18 and = 85 years of age.
•The patient has histologically confirmed prostate carcinoma.
•The indication for radical prostatectomy is present and the patient wishes to undergo this procedure.
•The patient is physically fit to participate in the planned procedures at the discretion of the investigator.
•At the discretion of the investigator, the patient is mentally capable of understanding the consequences of participation in the study and can adequately evaluate the resulting obligations.
•The patient gives written documented consent to study participation and the written documented informed consent form is available.
•The patient is able to follow the study instructions and is likely to attend all required study visits (compliance).
•The patient has the physical and cognitive ability to perform the physical training and participate in the psycho-oncology sessions, at the discretion of the investigator
•The patient has the physical and cognitive ability to handle digital media and play internet videos, e.g., for whole body fitness training.
•The patient has internet access and appropriate hardware to participate in the whole-body fitness training or to ensure transmission of data from the fitness watch vívosmart® 4 (by Garmin).

Exclusion Criteria

Patients who meet any of the following criteria will not be included in the study:
•The patient has a BMI > 40.
•The patient is concurrently participating in another clinical trial or has participated in a clinical trial within the last 30 days that involved the use of an investigational drug.
•The patient is or has been, to the knowledge or at the discretion of the investigator, dependent on medication, drugs, or alcohol.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is represented by multi-item scale urinary symptoms/ micturition symptoms, of the EORTC QLQ-PR25 questionnaire (to assess quality of life in prostate cancer). The primary endpoint will be assessed at the beginning at visit 1 and at follow-up visits 4-6 and will be compared to visit 1.