Prostate CancerNCT06985004
Predicting Operational Difficulties and Outcomes of RARP Based on Preoperative Assessment - Introducing the PIODO Questionnaire
An observational study of Prostate Cancer and Robot-Assisted Laparoscopic Radical Prostatectomy, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
The goal of this observational study is to learn about the factors that affect the course of robot-assisted radical prostatectomy and have an impact on functional and oncological outcomes in patients undergoing RARP. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Robot-Assisted Laparoscopic Radical Prostatectomy
- What is being tested?
- PIODO Questionnaire
- How many people
- 288 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators included in the study population consecutive patients with prostate cancer (diagnosis code C61 according to ICD-10 classification) who underwent elective RARP from January 2024 to December 2024 at the Department of Urology and Urological Oncology of Pomeranian Medical University in Szczecin.
Who may be able to join
- Patients with prostate cancer undergoing RARP.
Who cannot join
- Neoadjuvant androgen deprivation therapy before RARP.
- Lack of consent for study participation or willingness to comply with all procedures and assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Operational Difficulties and Outcomes of Robot-Assisted Radical Prostatectomy (RARP) Based on Preoperative Assessment - Introducing the PIODO (Preoperative Index for Operative Difficulties and Outcomes) Questionnaire
The goal of this observational study is to learn about the factors that affect the course of robot-assisted radical prostatectomy and have an impact on functional and oncological outcomes in patients undergoing RARP. The main question it aims to answer is:
- Can the investigators predict the occurrence of operational difficulties and outcomes of RARP based on preoperative assessment including body habitus and pelvimetry?
Participants undergoing RARP will be assessed preoperatively with the use of a PIODO Questionnaire, a structured protocol of preoperative assessment focusing on clinical data and MRI pelvic measurements to evaluate if the investigators can predict the risk of operational difficulties and possible outcomes of RARP. In a 1 year follow-up the investigators will collect data on functional and oncological outcomes.
Read the detailed description
Various factors affect the course of RARP and have an impact on functional and oncological outcomes. To date, no structured protocol has been developed for the preoperative assessment of patients undergoing RARP that evaluates not only clinical data on the prostate cancer, but also patient characteristics, including anthropometric measurements of the pelvis. Based on our previous research and preliminary study, the investigators have developed a PIODO Questionnaire to assess these factors and verify whether it is possible to predict the occurrence of operative difficulties as well as functional and oncological outcomes.
Participants undergoing RARP will be assessed preoperatively using the PIODO Questionnaire. The investigators will collect medical data and pelvic MRI measurements to evaluate if the investigators can predict the risk of operational difficulties and possible outcomes of RARP. In a 1-year follow-up, the investigators will obtain information on potency and continence, as well as the presence of biochemical recurrence.
Achieving our goal will allow us to facilitate counselling of patients on their relative likelihood of post-operative continence or erectile function based on individual factors and anthropometric measurements and allow urologists to predict operative difficulties they may face during surgery.
- Being tested
- PIODO Questionnaire
- Keywords
- Prostate cancer, RARP, robot-assisted radical prostatectomy, preoperative assessment, pelvimetry, magnetic resonance imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIODO QuestionnaireOther
An original PIODO Questionnaire is a structured protocol that has been developed by the investigators of this study for the preoperative assessment of patients undergoing RARP. It evaluates not only clinical data on the prostate cancer, but also patient characteristics, including anthropometric measurements of the pelvis. The aim is to develope a tool that can be used to predict the risk of operational difficulties and possible outcomes of RARP.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive patients with prostate cancer who underwent elective RARP | Not described Receives: Other: PIODO Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Index for Operative Difficulties and Outcomes (PIODO Questionnaire)
Preoperative assessment of patients undergoing RARP using an original questionnaire. The sum of the points obtained is presented as a number. The minimum value is 10 and maximum value is 34. The investigators' assumption is that the higher the score, the more difficult the surgery and the worse the functional and oncological outcome.
Measured: Preoperatively
Secondary outcomes (10)
Angle between the pubic bone and the prostate
The angle between the pros¬tatic urethra and the posterior side of the pubic bone. Measured in degrees on MRI T2-weighted images.
Measured: Preoperatively
Pubic symphysis-prostate apex length (PAL)
The distance between the extension lines of the suprapubic ridge line and the prostate apical line. Measured in centimeters on MRI T2-weighted images.
Measured: Preoperatively
Membranous urethral length (MUL)
The upper limit of MUL is the lower border of the peripheral zone of the prostate, dorsal to the membranous urethra. The lower limit of MUL is the origin of the penile base at the dorsal side of the urethral lumen. Measured in milimeters on MRI T2-weighted images.
Measured: Preoperatively
Protrusion of the prostate into the bladder
Evaluation of the presence or absence of protrusion of the prostate into the bladder. If the tip of the prostate protruded to the base of the urinary bladder, protrusion of the prostate into the bladder was considered present. Measured in milimeters on MRI T2-weighted images.
Measured: Preoperatively
Anteroposterior diameter of the pelvic inlet (API)
Diameter from the sacral promontory to the most superior aspect of the pubic symphysis. Measured in centimeters on MRI T2-weighted images.
Measured: Preoperatively
Pelvic depth (PD)
Diameter from the sacral promontory to the most inferior point of the pubic symphysis. Measured in centimeters on MRI T2-weighted images.
Measured: Preoperatively
The anteroposterior distance at the midpelvis (APM)
Diameter from the inferior aspect of the pubic symphysis to the sacrococcygeal junction. Measured in centimeters on MRI T2-weighted images.
Measured: Preoperatively
Pelvic outlet (APO)
Diameter from the inferior aspect of the pubic symphysis to the tip of the coccyx. Measured in centimeters on MRI T2-weighted images.
Measured: Preoperatively
Anteroposterior diameter of the working space during surgery (Workspace AP)
Diameter from anterior peritoneum to anterior border of coccyx (inner border). Measured in centimeters on MRI T2-weighted images.
Measured: Preoperatively
Transevrse diameter of the working space during surgery (Workspace T)
Diameter between medial border of acetabulum. Measured in centimeters on MRI T2-weighted images.
Measured: Preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985004
- Sponsor's protocol ID
- KB.006.121.2022/Z-110249
- Status last verified
- Mar 2025
- First submitted
- 9 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Operational Difficulties and Outcomes of Robot-Assisted Radical Prostatectomy (RARP) Based on Preoperative Assessment - Introducing the PIODO (Preoperative Index for Operative Difficulties and Outcomes) Questionnaire
- ClinicalTrials.gov ID
- NCT06985004
- Acronym / sponsor ID
- KB.006.121.2022/Z-110249
- Keywords
- Prostate cancer, RARP, robot-assisted radical prostatectomy, preoperative assessment, pelvimetry, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 May 2025 (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.
The goal of this observational study is to learn about the factors that affect the course of robot-assisted radical prostatectomy and have an impact on functional and oncological outcomes in patients undergoing RARP. The main question it aims to answer is:
- Can the investigators predict the occurrence of operational difficulties and outcomes of RARP based on preoperative assessment including body habitus and pelvimetry?
Participants undergoing RARP will be assessed preoperatively with the use of a PIODO Questionnaire, a structured protocol of preoperative assessment focusing on clinical data and MRI pelvic measurements to evaluate if the investigators can predict the risk of operational difficulties and possible outcomes of RARP. In a 1 year follow-up the investigators will collect data on functional and oncological outcomes.
Detailed description
Various factors affect the course of RARP and have an impact on functional and oncological outcomes. To date, no structured protocol has been developed for the preoperative assessment of patients undergoing RARP that evaluates not only clinical data on the prostate cancer, but also patient characteristics, including anthropometric measurements of the pelvis. Based on our previous research and preliminary study, the investigators have developed a PIODO Questionnaire to assess these factors and verify whether it is possible to predict the occurrence of operative difficulties as well as functional and oncological outcomes.
Participants undergoing RARP will be assessed preoperatively using the PIODO Questionnaire. The investigators will collect medical data and pelvic MRI measurements to evaluate if the investigators can predict the risk of operational difficulties and possible outcomes of RARP. In a 1-year follow-up, the investigators will obtain information on potency and continence, as well as the presence of biochemical recurrence.
Achieving our goal will allow us to facilitate counselling of patients on their relative likelihood of post-operative continence or erectile function based on individual factors and anthropometric measurements and allow urologists to predict operative difficulties they may face during surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients with prostate cancer who underwent elective RARP | – | Other: PIODO Questionnaire |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators included in the study population consecutive patients with prostate cancer (diagnosis code C61 according to ICD-10 classification) who underwent elective RARP from January 2024 to December 2024 at the Department of Urology and Urological Oncology of Pomeranian Medical University in Szczecin.
Key inclusion criteria (1 listed)
- Patients with prostate cancer undergoing RARP.
Key exclusion criteria (2 listed)
- Neoadjuvant androgen deprivation therapy before RARP.
- Lack of consent for study participation or willingness to comply with all procedures and assessments.
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 |
|---|---|---|
| PIODO QuestionnaireAn original PIODO Questionnaire is a structured protocol that has been developed by the investigators of this study for the preoperative assessment of patients undergoing RARP. It evaluates not only clinical data on the prostate cancer, but also patient characteristics, including anthropometric measurements of the pelvis. The aim is to develope a tool that can be used to predict the risk of operational difficulties and possible outcomes of RARP. | Other | Consecutive patients with prostate cancer who underwent elective RARP |
Primary outcome
Preoperative Index for Operative Difficulties and Outcomes (PIODO Questionnaire)
Time frame: Preoperatively
Preoperative assessment of patients undergoing RARP using an original questionnaire. The sum of the points obtained is presented as a number. The minimum value is 10 and maximum value is 34. The investigators' assumption is that the higher the score, the more difficult the surgery and the worse the functional and oncological outcome.
10 secondary outcomes
Angle between the pubic bone and the prostate
Time frame: Preoperatively
Pubic symphysis-prostate apex length (PAL)
Time frame: Preoperatively
Membranous urethral length (MUL)
Time frame: Preoperatively
Protrusion of the prostate into the bladder
Time frame: Preoperatively
Anteroposterior diameter of the pelvic inlet (API)
Time frame: Preoperatively
Pelvic depth (PD)
Time frame: Preoperatively
The anteroposterior distance at the midpelvis (APM)
Time frame: Preoperatively
Pelvic outlet (APO)
Time frame: Preoperatively
Anteroposterior diameter of the working space during surgery (Workspace AP)
Time frame: Preoperatively
Transevrse diameter of the working space during surgery (Workspace T)
Time frame: Preoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Robot-Assisted Laparoscopic Radical Prostatectomy, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Preoperative Index for Operative Difficulties and Outcomes (PIODO Questionnaire) (time frame: Preoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025.