Prostate CancerANCAPRONCT07351461
Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.
An observational study of Prostate Cancer, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Patient on active surveillance
- How many people
- 432 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2025to 23 Mar 2027
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille
Jonathan OLIVIER, Dr, 0320444398, jonathan.olivier@chu-lille.fr
About this study
Official title: Quantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.
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.
- Conditions
- Prostate Cancer
- Being tested
- Patient on active surveillance
- Keywords
- Prostate cancer, Anxiety
- Medical subject headings
- Prostatic Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer
Questionnaire assessing anxiety (STAI-Y questionnaire).
Measured: 12 months
To determine the clinical predictive factors of anxiety in patients on active surveillance.
Use of questionnaires assessing general anxiety (STAI-Y questionnaire) in patients and their partners.
Measured: 12 months
To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies.
Assessment of intra- and interpersonal emotional skills.
Measured: 12 months
To identify the potential causes of anxiety.
Participants scoring between 115 and 145 on the DCI are considered within the normal range. A score below 115 indicates that participants use dyadic coping strategies less frequently than average. A score above 145 indicates that participants use dyadic coping strategies more frequently than average.
Measured: 12 months
Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners.
Assessment of intra- and interpersonal emotional skills.
Measured: 12 months
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate
Questionnaire assessing the management of emotions (S-PEC questionnaire).
Measured: 12 months
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate
Questionnaire assessing the stress (Dyadic coping inventory questionnaire).
Measured: 12 months
To determine the clinical predictive factors of anxiety in patients on active surveillance.
Use of questionnaires assessing the stress (Dyadic coping inventory questionnaire) in patients and their partners.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start23 Mar 2025
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Mar 2027 (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.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351461
- Sponsor's protocol ID
- 2023_0457
- Acronym
- ANCAPRO
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 20 Jan 2026
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.
- ClinicalTrials.gov ID
- NCT07351461
- Acronym / sponsor ID
- ANCAPRO / 2023_0457
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 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. | Other | – |
Primary outcome
Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer.
Time frame: 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.
8 secondary outcomes
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer
Time frame: 12 months
To determine the clinical predictive factors of anxiety in patients on active surveillance.
Time frame: 12 months
To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies.
Time frame: 12 months
To identify the potential causes of anxiety.
Time frame: 12 months
Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners.
Time frame: 12 months
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate
Time frame: 12 months
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate
Time frame: 12 months
To determine the clinical predictive factors of anxiety in patients on active surveillance.
Time frame: 12 months
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 20 Jan 2026.
- 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.
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, run by University Hospital, Lille at 1 site in France.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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 France. 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?
Contact Jonathan OLIVIER, Dr (0320444398, jonathan.olivier@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer. (time frame: 12 months). 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 20 Jan 2026.