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NCT Number: NCT07156903

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Patients and their care-givers will be asked to participate in interviews

Primary outcomes

  1. Qualitative Evaluation of Interviews

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Franziska Hausmann, MD

CONTACT

[email protected]

+4930 450 557000

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Qualitative Erhebung Zur Erfassung Der Bedürfnisse Von Patienten Und Deren Angehörigen während Und Nach Einer Strahlentherapie Bei Prostatakarzinomerkrankung Und Deren Einstellung Und Wünsche bezüglich Einer Prähabilitationsmaßnahme

Acronym: PrähabPro

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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