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Recruiting Observational

Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.

NCT07351461 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-03-23
Last updated
2026-01-20

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Patient on active surveillance

Patient on active surveillance: * First, a quantitative cross-sectional study of patients on active surveillance at Lille University Hospital, which will aim to determine the prevalence of anxiety disorders in patients and, if possible, in their partners. * Then, a qualitative study to explore the potential causes of this anxiety.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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. * Having a life partner or an unidentified partner recognized as the person sharing the patient's daily life Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer. — 12 months
    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.

Trial sites (1)

FacilityCityRegionStatus
CHU de Lille Lille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07351461 on ClinicalTrials.gov ↗ ← All trials in France