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ANCAPRO

Quantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Anxiety Disorders
+9

+ Mental Disorders
+ Genital Diseases, Male
Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2025
See protocol details

Summary

Principal SponsorUniversity Hospital, Lille
Study ContactJonathan OLIVIER, Dr
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 23, 2025Actual date on which the first participant was enrolled.

Prostate cancer (PCa) is the most common cancer and the third leading cause of cancer-related death among men in France. Active surveillance is one of the management options for low-risk prostate cancer. Its aim is to delay or avoid radical treatment, such as surgery or radiotherapy, which can cause side effects including urinary incontinence, erectile dysfunction, or radiation-induced cystitis. Active surveillance involves regular monitoring of potential tumor progression through serum PSA testing, MRI scans, and prostate biopsies. Few studies have investigated the psychological adjustment of patients undergoing active surveillance for prostate cancer, and even fewer have explored the relationship between the patients' anxiety symptoms and those of their partners. To our knowledge, no study has yet quantitatively or qualitatively assessed the anxiety of both patients and their partners. It appears essential to better characterize the anxiety symptoms in these individuals in order to offer them appropriate psychological support.

Official TitleQuantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners. 
NCT07351461
Principal SponsorUniversity Hospital, Lille
Study ContactJonathan OLIVIER, Dr
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
432 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Anxiety Disorders
Mental Disorders
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Prostatic Neoplasms
Urogenital Neoplasms
Male Urogenital Diseases
Urogenital Diseases
Genital Diseases
Criteria
5 inclusion criteria required to participate
Age ≥ 18 years.
Patients who started active surveillance for localized prostate cancer from 2007 to 2023 and are followed in the Urology Department of Lille University Hospital.
Affiliation to a social security scheme.
Obtaining patient consent.

Show More Criteria

4 exclusion criteria prevent from participating
Lack of proficiency in the French language.
Minor patients, those under legal protection measures, or deprived of liberty.
Lack of medical insurance coverage.
Patients refusing to participate in the study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Total score of the 'Memorial Anxiety Scale for Prostate Cancer' questionnaire, whose French translation has been validated (Touzani et al., 2019). Patients scoring \>27/54 are classified as anxious.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
CHU de LilleLille, FranceSee the location
Recruiting
One Study Center