Prospective minimally interventional clinical trial of the "Prostate Cancer Decision Aid" to determine the reduction of decisional conflict and the strengthening of health literacy in patients with newly diagnosed, locally treatable prostate cancer

Prospective minimally interventional clinical trial of the "Prostate Cancer Decision Aid" to determine the reduction of decisional conflict and the strengthening of health literacy in patients with newly diagnosed, locally treatable prostate cancer - PROMINENT-PCA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034308

Enrollment

500

Registered

2024-05-24

Start date

2025-02-19

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Control group: Answering questionnaires after using the "Prostate cancer decision aid" Group 2: Intervention group: Answering questionnaires before using the "Prostate cancer decision aid"

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Histologically confirmed prostate carcinoma before the start of primary therapy - Age >18 years - Proficiency in the German language - Consent to participate in the study - Ability to use a digital device with at least one relative - Internet access and e-mail address available

Exclusion criteria

Exclusion criteria: - Age < 18 years - Patients not able to give consent - Patients under legal care

Design outcomes

Primary

Measure	Time frame
Reduction of the decisional conflict (score of the "Decisional Conflict Scale") by 12.5 points	—

Secondary

Measure	Time frame
- Patient knowledge about prostate cancer (score of the test to "assess the level of knowledge about prostate cancer") - Emotional stress (score of the distress thermometer) - Patient preference (questionnaire - "What can you imagine? - multiple choice") - Usability of the "Prostate cancer decision aid" - Recording of possible side effects and risks	—

Countries

Germany

Contacts

Public ContactJohannes Huber, FEBU, MHBA

Urologische Universitätsklinik Heidelberg

johannes.huber@med.uni-heidelberg.de+49 6221 56-36479

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026