Prostate CancerPRO-PNCT05644821

Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome

A study testing complex intervention and current clinical practice in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study investigates the influence of structured follow-up using ePROMS in the 1st year after prostatectomy on the postoperative course. It will be examined whether this intervention leads to early detection of postoperative symptoms and whether the subsequent initiation of further measures lead to an improvement of… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: complex intervention and current clinical practice
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 260 participants
Where: 5 sitesGermany
Study dates: 1 Aug 2023to 31 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

age ≥ 18 y
legal capacity
sufficient knowledge of the German language
prostate carcinoma, TNM T1-4 NX N0-1 M0-1c
primary radical prostatectomy planned
mobile input device or PC available
ability to either receive emails or install a special app on cell phone and receive push messages, with guidance or assistance if necessary
ability to complete electronic questionnaires, with guidance or assistance if necessary

Who cannot join

palliative treatment situation (life expectancy < 1 year)
preoperative urinary incontinence (at least one pad per 24 hours)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

University Clinic Bonn, Urology
Bonn, North Rhine Westpahlia, 53127
Klinikum Dortmund gGmbH, Urology
Dortmund, North Rhine-Westphalia, 44145
University Clinic Düsseldorf, Urology
Düsseldorf, North Rhine-Westphalia, 40223
University Clinik Bochum, Marienhospital Herne, Urology
Herne, North Rhine-Westphalia, 44625
University Clinic Münster, Urology
Münster, North Rhine-Westphalia, 48149

Other trials in Germany

About this study

Read the detailed description

PRO-P is planned as a multicenter, prospective, and two-arm randomized control group study in which ePROMs will be performed in a standardized fashion once before and six times (intervention group) or three times (control group) after primary prostatectomy in patients with PCa. PROMs are collected either web-based or through a dedicated app and entered by the patient using either a mobile device or computer. Patients are invited to enter ePROMS into the app or web tool through email and app-driven push messages. Patients who are incontinent (at least one pad in 24 hours) at the 6-week postoperative survey are randomized into two groups: The intervention group and the control group. In the intervention group, when the respective questionnaire cut-off values are exceeded in the ePROM survey, an alarm is triggered at the treating prostate cancer center and contact is made by the center as well as subsequent measures, if necessary. This is done at 6 weeks postoperatively and at 12, 18, 24, 36 and 52 weeks postoperatively. In the control group, ePROMs are recorded 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group thus receives treatment in accordance with the current clinical routine. The mechanisms of action of the intervention will be investigated within the framework of a qualitative process evaluation. Characteristics on the patient level (e.g., treatment-related attitudes, comorbidity, social support), on the practitioner level (e.g., communication skills), on the organizational level, and the interactions between the levels (e.g., patient-doctor relationship) will be explored. The goal is to develop an intervention model, or to describe the effective elements of the intervention.

Conditions: Prostate Cancer
Being tested: complex intervention, current clinical practice
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

complex interventionOther
The intervention has several elements:
1. Regular symptom monitoring via ePROMs
2. Alarm when defined thresholds of EPIC-26 or PHQ-4 are reached or exceeded, 3.) In case of alarm, standardized telephone contact by a study nurse at the treating center with the offer to coordinate a urological consultation at the center, 4.) if requested by the patient: a urological consultation at the treating prostate cancer center by urologists trained in the PRO-P study,
3. content of the consultation: if necessary, the guideline-compliant initiation of further diagnostics and therapy including in this context necessary follow-up contacts and 5) postal communication of the ePROM results in case of an alarm as well as postal dispatch of a report of the findings in case of a urological consultation at the treating prostate cancer center to the practicing, treating urologist.
current clinical practiceOther
current clinical practice

Study groups in NCT05644821
Study group	Role	What they receive
Intervention group	Experimental	Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the intervention group, when the respective questionnaire thresholds are exceeded in the ePROM survey, an alarm is triggered at the treating prostate cancer center and contact is made by the center, as well as subsequent actions, if necessary. Receives: Other: complex intervention
Control group	No intervention	Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the control group, ePROMs will be collected 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group will therefore receive treatment according to the current clinical routine.
Comparison group	Other	In patients who are fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours), ePROMs are collected at 24 and 52 weeks, but no alarms or further actions are derived from them. Thus, treatment is provided according to routine clinical practice. Patients are not randomized. Receives: Other: current clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

urinary incontinence
The Expanded Prostate Cancer Index Short Form (EPIC-26) is a questionnaire that assesses symptoms and functions of people with prostate cancer in 5 domains. A total of 100 points can be achieved for each domain, with a higher score indicating better function. The urinary incontinence domain consists of four items. To calculate the primary endpoint, the difference between the scores on the urinary incontinence scale of the EPIC-26 is taken at 52 and 6 weeks. Changes regarding urinary incontinence (Minimally Important Difference (MID) >= 9) at 52 weeks postoperatively compared with 6 weeks postoperatively are considered.
Measured: 52 weeks

Secondary outcomes (11)

EPIC-26: changes in sexual function
Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in in sexual function according to EPIC-26 (MID >= 10).
Measured: 52 weeks
EPIC-26: changes in irritative/obstructive symptoms
Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in irritative/obstructive an gastrointestinal symptoms according to EPIC-26 (MID >= 7).
Measured: 52 weeks
EPIC-26: changes in gastrointestinal symptoms
Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes an gastrointestinal symptoms according to EPIC-26 (MID >= 5).
Measured: 36 months
EPIC-26: changes in vitality/hormonal function
Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in vitality/ hormonal function according to EPIC-26 (MID >= 4).
Measured: 52 weeks
EQ-5D-5L: changes in health-related quality of life (HRQoL)
The European Quality of Life Five-Dimensions Questionnaire (EQ-5D-5L) measures health-related quality of life on five scales: 1. mobility, 2. ability to care for oneself, 3. activities of daily living, 4. pain/physical discomfort, and 5. anxiety/dejection, each of which is represented by a question that provides five response options for grading symptoms. In addition, a question on self-assessment of health status is asked on a visual analog scale from 0 to 100, where 100 is the best imaginable health.
Measured: 52 weeks
PHQ-4: changes in depressivity
The Patient Health Questionnaire-4 (PHQ-4) measures depressiveness and generalized anxiety on two subscales with two items each. For each question, scores from 0 to 3 can be achieved, so that a cumulative score of 12 points can be reached, whereby a higher score indicates a more pronounced symptomatology. The cut-off value for depressivity is defined for the subscales of the PHQ-4 is definied by >= 3 points, the respective attainment of which (independent of the preoperative value) triggers an alarm at each survey time point.
Measured: 52 weeks
PHQ-4: changes in generalised anxiety
The Patient Health Questionnaire-4 (PHQ-4) measures depressiveness and generalized anxiety on two subscales with two items each. For each question, scores from 0 to 3 can be achieved, so that a cumulative score of 12 points can be reached, whereby a higher score indicates a more pronounced symptomatology. The cut-off value for depressivity is defined for the subscales of the PHQ-4 is definied by >= 3 points, the respective attainment of which (independent of the preoperative value) triggers an alarm at each survey time point.
Measured: 52 weeks
PEI: changes in patient enablement
The Patient Enablement Instrument (PEI) measures patient empowerment through six questions; a validated German translation with a modified question sequence and Likert scale is used. Overall, the sum score ranges from 6 to 30 points, with a higher score corresponding to greater patient empowerment.
Measured: 52 weeks
qualitative process evaluation - module 1: feasibility
semi-structured interviews with patients, urologists, psychooncologists, study nurses (N=10-15); data from Module 1 will be evaluated qualitatively using content analysis; criteria are based on the feasibility criteria for evaluating the acceptance and feasibility of the intervention and the study procedures
Measured: 52 weeks
qualitative process evaluation - module 2: impact
sequential semi-structured interviews with patients and relatives from the intervention and control groups in the main study (N=30-40); data from module 2 will be evaluated by contrastive thematic coding; in addition to possible differences between the intervention and control groups, intraindividual changes are also evaluated by contrastive coding of the data material at several time points
Measured: 52 weeks
qualitative process evaluation - module 3: implementation
Semi-structured interviews with urologists, psychooncologists, study nurses in the main study (N=10-15); focus group discussion with study participants; analysis of implementation factors is guided by the Consolidated Framework for Advancing Implementation Science (CFIR); data from module 3 on implementation are evaluated qualitatively by content analysis
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202331 Mar 2026

First posted9 Dec 2022
Study start1 Aug 2023
Primary completion31 Mar 2026
Study completion31 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Intention-to-treat principle, comparison (regarding superiority) of primary endpoint using mixed linear model for repeated measures: dependent variable: primary endpoint, influencing factors: Indicator for intervention/control group, time, group\*time, center, tumor stage, and age group; downstream sequential-rejection testing of equality of expected values in the individual strata via appropriate contrasts; control of multiple error for at least one false rejection (final test principle); supplementary: mixed linear models with additional independent variables; sensitivity analyses on the influence of missing values (multiple imputation); subgroup analyses according to center, stage, and age group
Masking: None (open label)
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05644821
Sponsor's protocol ID: 2022-2148
Acronym: PRO-P
Status last verified: Aug 2026
First submitted: 18 Nov 2022
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Al-Monajjed R, Albers P, Droop J, Fugmann D, Noldus J, Palisaar RJ, Ritter M, Ellinger J, Krausewitz P, Truss M, Hadaschik B, Grunwald V, Schrader AJ, Papavassilis P, Ernstmann N, Schellenberger B, Moritz A, Kowalski C, Hellmich M, Heiden P, Hagemeier A, Horenkamp-Sonntag D, Giessing M, Pauler L, Dieng S, Peters M, Feick G, Karger A; PRO-P study group. PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial. Trials. 2024 Nov 12;25(1):754. doi: 10.1186/s13063-024-08579-8.
PubMed 39533412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome
ClinicalTrials.gov ID: NCT05644821
Acronym / sponsor ID: PRO-P / 2022-2148
Conditions: Prostate Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Heinrich-Heine University, DuesseldorfUniversity, hospital or other
Collaborators: Marienhospital Herne, University Hospital, Essen, University Hospital, Bonn, Klinikum Dortmund, University Hospital Muenster, University Hospital of Cologne, University of Cologne, Techniker Krankenkasse, Deutsche Krebsgesellschaft e.V.
Study start: 1 Aug 2023 (actual)
Primary completion: 31 Mar 2026 (actual)
Study completion: 31 Mar 2026 (actual)
First posted: 9 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Intention-to-treat principle, comparison (regarding superiority) of primary endpoint using mixed linear model for repeated measures: dependent variable: primary endpoint, influencing factors: Indicator for intervention/control group, time, group*time, center, tumor stage, and age group; downstream sequential-rejection testing of equality of expected values in the individual strata via appropriate contrasts; control of multiple error for at least one false rejection (final test principle); supplementary: mixed linear models with additional independent variables; sensitivity analyses on the influence of missing values (multiple imputation); subgroup analyses according to center, stage, and age group

Arm	Type	Receives
Intervention group	Experimental	Other: complex interventionPatients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the intervention group, when the respective questionnaire thresholds are exceeded in the ePROM survey, an alarm is triggered at the treating prostate cancer center and contact is made by the center, as well as subsequent actions, if necessary.
Control group	No intervention	–Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the control group, ePROMs will be collected 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group will therefore receive treatment according to the current clinical routine.
Comparison group	Other	Other: current clinical practiceIn patients who are fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours), ePROMs are collected at 24 and 52 weeks, but no alarms or further actions are derived from them. Thus, treatment is provided according to routine clinical practice. Patients are not randomized.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

age ≥ 18 y
legal capacity
sufficient knowledge of the German language
prostate carcinoma, TNM T1-4 NX N0-1 M0-1c
primary radical prostatectomy planned

Key exclusion criteria (2 listed)

palliative treatment situation (life expectancy < 1 year)
preoperative urinary incontinence (at least one pad per 24 hours)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
complex interventionThe intervention has several elements: 1. Regular symptom monitoring via ePROMs 2. Alarm when defined thresholds of EPIC-26 or PHQ-4 are reached or exceeded, 3.) In case of alarm, standardized telephone contact by a study nurse at the treating center with the offer to coordinate a urological consultation at the center, 4.) if requested by the patient: a urological consultation at the treating prostate cancer center by urologists trained in the PRO-P study, 4) content of the consultation: if necessary, the guideline-compliant initiation of further diagnostics and therapy including in this context necessary follow-up contacts and 5) postal communication of the ePROM results in case of an alarm as well as postal dispatch of a report of the findings in case of a urological consultation at the treating prostate cancer center to the practicing, treating urologist.	Other	Intervention group
current clinical practicecurrent clinical practice	Other	Comparison group

Primary outcome

urinary incontinence
Time frame: 52 weeks
The Expanded Prostate Cancer Index Short Form (EPIC-26) is a questionnaire that assesses symptoms and functions of people with prostate cancer in 5 domains. A total of 100 points can be achieved for each domain, with a higher score indicating better function. The urinary incontinence domain consists of four items. To calculate the primary endpoint, the difference between the scores on the urinary incontinence scale of the EPIC-26 is taken at 52 and 6 weeks. Changes regarding urinary incontinence (Minimally Important Difference (MID) >= 9) at 52 weeks postoperatively compared with 6 weeks postoperatively are considered.

11 secondary outcomes

EPIC-26: changes in sexual function
Time frame: 52 weeks
EPIC-26: changes in irritative/obstructive symptoms
Time frame: 52 weeks
EPIC-26: changes in gastrointestinal symptoms
Time frame: 36 months
EPIC-26: changes in vitality/hormonal function
Time frame: 52 weeks
EQ-5D-5L: changes in health-related quality of life (HRQoL)
Time frame: 52 weeks
PHQ-4: changes in depressivity
Time frame: 52 weeks
PHQ-4: changes in generalised anxiety
Time frame: 52 weeks
PEI: changes in patient enablement
Time frame: 52 weeks
qualitative process evaluation - module 1: feasibility
Time frame: 52 weeks
qualitative process evaluation - module 2: impact
Time frame: 52 weeks
qualitative process evaluation - module 3: implementation
Time frame: 52 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Derived from this study: PubMed 39533412Al-Monajjed R, Albers P, Droop J, Fugmann D, Noldus J, Palisaar RJ, Ritter M, Ellinger J, Krausewitz P, Truss M, Hadaschik B, Grunwald V, Schrader AJ, Papavassilis P, Ernstmann N, Schellenberger B, Moritz A, Kowalski C, Hellmich M, Heiden P, Hagemeier A, Horenkamp-Sonntag D, Giessing M, Pauler L, Dieng S, Peters M, Feick G, Karger A; PRO-P study group. PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial. Trials. 2024 Nov 12;25(1):754. doi: 10.1186/s13063-024-08579-8.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Albers, MD principal investigator

University Clinic Düsseldorf, Urology

André Karger, MD study director

University Clinic Düsseldorf, psychosomatic medicine

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing complex intervention and current clinical practice in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

urinary incontinence (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05644821, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.