NCT07351461

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Mar 2025Mar 2027

Study Start

First participant enrolled

March 23, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2027

Last Updated

January 20, 2026

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 23, 2025

Last Update Submit

January 9, 2026

Conditions

Prostate Cancer

Keywords

Prostate cancerAnxiety

Outcome Measures

Primary Outcomes (1)

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

    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.

    12 months

Secondary Outcomes (8)

  • Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer

    12 months

  • To determine the clinical predictive factors of anxiety in patients on active surveillance.

    12 months

  • To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies.

    12 months

  • To identify the potential causes of anxiety.

    12 months

  • Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners.

    12 months

  • +3 more secondary outcomes

Interventions

Patient on active surveillanceOTHER

* 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who started active surveillance for localized prostate cancer between 2007 and 2023 and are followed in the Urology Department of Lille University Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMental Disorders

Central Study Contacts

Jonathan OLIVIER, Dr

CONTACT

0320444398jonathan.olivier@chu-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2025

First Posted

January 20, 2026

Study Start

March 23, 2025

Primary Completion (Estimated)

March 23, 2027

Study Completion (Estimated)

March 23, 2027

Last Updated

January 20, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)