Evaluation of Needs of Patients and Care-givers During and After Radiotherapy of Patients With Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer Patients

• Registration Number: NCT07156903
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Exploratory qualitative survey to assess the needs of patients and their relatives during and after radiotherapy for prostate cancer and their attitudes and wishes regarding prehabilitation measures

Detailed Description

Across Germany, more than 500,000 people are newly diagnosed with cancer each year (Center for Cancer Registry Data, RKI, 2020). Prostate cancer, the most common cancer in men, affects more than 65,000 patients annually (https://www.krebsinformationsdienst.de/prostatakrebs). The gold standard for the treatment of advanced prostate cancer is radiotherapy combined with anti-hormonal therapy. If the cancer is detected earlier, surgery can be performed. Both procedures are then considered to be oncologically equivalent. Despite the most modern treatment methods and techniques, severe acute and long-term side effects still occur, which patients can experience as extremely limiting. These include, among other things, loss of libido and erectile function, the development of bladder weakness and even incontinence, and changes in bowel function (e.g., diarrhea).

Currently, patients often only begin treatments designed to mitigate these side effects during their rehabilitation, at least 4-6 weeks after therapy. However, the investigators believe that greater effects can be achieved and even the occurrence of serious side effects can be potentially prevented if treatment is initiated before or during therapy. This concept is called prehabilitation.

In order to develop a suitable prehabilitation program for prostate cancer patients undergoing curative radiation therapy (either definitive or postoperative), the investigators will conduct interviews with patients and, if possible, their immediate family members (e.g., partners) to learn more about their experiences before, during, and after the treatment. The investigators would also like to learn more about their attitudes and wishes regarding prehabilitation measures.

Study Timeline

• Study Start: 2025-08-01
• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-10-31
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Diagnosed Prostate Cancer with curativ intended Radiotherapy
• min. 18 years
• sufficient knowledge of German language for participation in interviews
• Capacity to consent

Exclusion Criteria

• age <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Qualitative Evaluation of Interviews	interviews will take place once either during radiotherapy or during follow up (planned 30 participants each); Each interview is expected to last 60 minutes.	This is an exploratory, qualitative study. The data will be coded or analyzed thematically.

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany