Radical ProstatectomiesPREduKinéNCT06815055
State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer : Prospective, Monocentric, National Survey, Aiming to Explore the Technics of Physiotherapy (PREduKiné)
An observational study of Radical Prostatectomies and Rehabilitation Outcome, run by Centre Hospitalier de Roubaix.
Trial summary
In France, a considerable number of radical prostactectomy for cancer is carried out every year.This number was estimated at 20.000 in 2016.This surgery may have negative impact on the continence's subjects and their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Radical Prostatectomies, Rehabilitation Outcome, Prostate Cancer
- What is being tested?
- Quality of life questionnary
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Dec 2026
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The population concerned by the study is national french territory. Subjects must have an postoperative follow up performing by an urologist.
Who may be able to join
- men who has undergone a radical prostactectomy to treat a prostatic adenocarcinoma
- having a follow up postoperative consultation between one and two month after the surgery
- being able to answer to respond the questions during the interviews
- agreeing to participate by signing informed consent form
Who cannot join
- undergoing an adjuvant therapy as radiotherpy, chemotherapy and hormone therapy
- Refusing to take part in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PREduKiné State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer : Prospective, Monocentric, National Survey, Aiming to Explore the Technics of Physiotherapy
In France, a considerable number of radical prostactectomy for cancer is carried out every year.This number was estimated at 20.000 in 2016.This surgery may have negative impact on the continence's subjects and their quality of life. The rehabilitation, preoperative or postoperative, practiced by a physiotherapist, can reduced those side effects. The rehabilitation techniques are many and their efficacy may differ.
No study where found about the clasification and evaluation of those rehabilitation techniques.
Read the detailed description
Investigator aim to create homogeneous clusters of subjects according to the rehabilitation techniques they have received during the preoperative or postoperative period, using a survey replied 6 months after the surgery.
To achieve that goal, invesgator will call subjects conduct two interviews. The first interview will take place around one month after the radical prostatectomy and the second around 6 month after the surgery.
During those interviews, investigator will question subjects about the rehabilitation techniques practiced on them, about their continence and quality of life. To evaluate the continence investigator will use the survey ICIQ-SF. To evaluate the quality of life, investagator will use the survey KHQ-HR Qol.
- Conditions
- Radical Prostatectomies, Rehabilitation Outcome, Prostate Cancer, Prostate Cancer Surgery, Rehabilitation Exercise
- Being tested
- Quality of life questionnary
- Keywords
- radical prostatectomy, rehabilitation, continence, quality of life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaryOther
Subjects will be call 1 month and 6 months after prostetectomy to evaluate the type of reeducation received and they will be evaluated with the help of QoL questionnaries : KHQ-HR QoL and ICIQ-SF QoL
What is being measured
The primary outcome is the main question the study is designed to answer.
Set up homogeneous groups of subjects (clusters)
The primary outcome is a survey questionning the subject about the rehabilitation techniques realised during the post operative period. This survey will be asked during a phone interview directed by investgator.
Measured: It will take place around six months after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radical ProstatectomiesStudies 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
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Roubaix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815055
- Sponsor's protocol ID
- 2022-010
- Acronym
- PREduKiné
- Status last verified
- Jun 2025
- First submitted
- 4 Feb 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREduKiné State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer : Prospective, Monocentric, National Survey, Aiming to Explore the Technics of Physiotherapy
- ClinicalTrials.gov ID
- NCT06815055
- Acronym / sponsor ID
- PREduKiné / 2022-010
- Conditions
- Radical Prostatectomies, Rehabilitation Outcome, Prostate Cancer, Prostate Cancer Surgery, Rehabilitation Exercise
- Keywords
- radical prostatectomy, rehabilitation, continence, quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Centre Hospitalier de RoubaixUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Feb 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.
In France, a considerable number of radical prostactectomy for cancer is carried out every year.This number was estimated at 20.000 in 2016.This surgery may have negative impact on the continence's subjects and their quality of life. The rehabilitation, preoperative or postoperative, practiced by a physiotherapist, can reduced those side effects. The rehabilitation techniques are many and their efficacy may differ.
No study where found about the clasification and evaluation of those rehabilitation techniques.
Detailed description
Investigator aim to create homogeneous clusters of subjects according to the rehabilitation techniques they have received during the preoperative or postoperative period, using a survey replied 6 months after the surgery.
To achieve that goal, invesgator will call subjects conduct two interviews. The first interview will take place around one month after the radical prostatectomy and the second around 6 month after the surgery.
During those interviews, investigator will question subjects about the rehabilitation techniques practiced on them, about their continence and quality of life. To evaluate the continence investigator will use the survey ICIQ-SF. To evaluate the quality of life, investagator will use the survey KHQ-HR Qol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population concerned by the study is national french territory. Subjects must have an postoperative follow up performing by an urologist.
Key inclusion criteria (4 listed)
- men who has undergone a radical prostactectomy to treat a prostatic adenocarcinoma
- having a follow up postoperative consultation between one and two month after the surgery
- being able to answer to respond the questions during the interviews
- agreeing to participate by signing informed consent form
Key exclusion criteria (2 listed)
- undergoing an adjuvant therapy as radiotherpy, chemotherapy and hormone therapy
- Refusing to take part in the study
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 |
|---|---|---|
| Quality of life questionnarySubjects will be call 1 month and 6 months after prostetectomy to evaluate the type of reeducation received and they will be evaluated with the help of QoL questionnaries : KHQ-HR QoL and ICIQ-SF QoL | Other | – |
Primary outcome
Set up homogeneous groups of subjects (clusters)
Time frame: It will take place around six months after the surgery.
The primary outcome is a survey questionning the subject about the rehabilitation techniques realised during the post operative period. This survey will be asked during a phone interview directed by investgator.
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 5 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Radical Prostatectomies and Rehabilitation Outcome, run by Centre Hospitalier de Roubaix.
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 4 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: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Camille Trouillet, Clinical Research Associate (0033320993131, camille.trouillet@ch-roubaix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Set up homogeneous groups of subjects (clusters) (time frame: It will take place around six months after the surgery.). 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 5 Jun 2025.