Prostate CancerQUALIFYNCT06945172
Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU
A study testing Total prostatectomy and Focal HIFU in people with Prostate Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is: What is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Total prostatectomy and Focal HIFU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Interventional
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male, aged between ≥ 40 and ≤ 75 years
- Patient with a life expectancy > 10 years at the time of inclusion.
- Patient with a therapeutic strategy (prostatectomy or focal HIFU) defined during a PCR.
- Patient with a diagnosis of localised prostate cancer at favourable intermediate risk
- Patient able to tolerate general anaesthesia or type IV sedation
- Patient with normal urinary continence status
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- Patient with satisfactory erectile function allowing penetration:
- Patient with targeted biopsies and systematic biopsies
- Patient affiliated to or benefiting from a social security scheme
- French-speaking patients who do not object to the use of their data.
Who cannot join
- Patients with a contraindication to MRI
- Stage T3a or b on MRI
- Patient on long-term anticoagulants and unable to stop them.
- Patient already included in another study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
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
Clinique La Croix du Sud
Quint-Fonsegrives, 31130
Guillaume PLOUSSARD, MD, +33 6 84 11 85 09, dr.gploussard@gmail.com
About this study
The goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is:
What is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal HIFU ?
Researchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal HIFU to see their quality of life.
Participants will answer EPIC-CP questionnaire 6 months, 12 months and 24 months after treatment
- Conditions
- Prostate Cancer
- Being tested
- Total prostatectomy, Focal HIFU
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total prostatectomyProcedure or surgery
Total prostatectomy is a surgical procedure performed to treat prostate cancer.
Focal HIFUProcedure or surgery
Focal HIFU treatment is an innovative technique that consists of destroying prostate tumour cells using high-intensity ultrasound focused exclusively on the affected area of the gland.
| Study group | Role | What they receive |
|---|---|---|
| Total prostatectomy | Active comparator | Patient will undergo total prostatectomy as a treatment for their cancer Receives: Procedure: Total prostatectomy |
| Focal HIFU | Experimental | Patient will undergo focal HIFU as a treatment for their cancer Receives: Procedure: Focal HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life in relation to prostate cancer
Quality of life in relation to prostate cancer will be assessed by the total score (ranging from 0 to 60) of the EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) questionnaire. Higher score means a worse outcome.
Measured: Month 6, month 12 and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945172
- Sponsor's protocol ID
- 2024-A02716-41
- Other IDs
- 2024-A02716-41
- Acronym
- QUALIFY
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2025
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU
- ClinicalTrials.gov ID
- NCT06945172
- Acronym / sponsor ID
- QUALIFY / 2024-A02716-41
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Apr 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.
The goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is:
What is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal HIFU ?
Researchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal HIFU to see their quality of life.
Participants will answer EPIC-CP questionnaire 6 months, 12 months and 24 months after treatment
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total prostatectomy | Active comparator | Procedure: Total prostatectomyPatient will undergo total prostatectomy as a treatment for their cancer |
| Focal HIFU | Experimental | Procedure: Focal HIFUPatient will undergo focal HIFU as a treatment for their cancer |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient, male, aged between ≥ 40 and ≤ 75 years
- Patient with a life expectancy > 10 years at the time of inclusion.
- Patient with a therapeutic strategy (prostatectomy or focal HIFU) defined during a PCR.
- Patient with a diagnosis of localised prostate cancer at favourable intermediate risk
- Patient able to tolerate general anaesthesia or type IV sedation
Key exclusion criteria (5 listed)
- Patients with a contraindication to MRI
- Stage T3a or b on MRI
- Patient on long-term anticoagulants and unable to stop them.
- Patient already included in another study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Total prostatectomyTotal prostatectomy is a surgical procedure performed to treat prostate cancer. | Procedure or surgery | Total prostatectomy |
| Focal HIFUFocal HIFU treatment is an innovative technique that consists of destroying prostate tumour cells using high-intensity ultrasound focused exclusively on the affected area of the gland. | Procedure or surgery | Focal HIFU |
Primary outcome
Quality of Life in relation to prostate cancer
Time frame: Month 6, month 12 and month 24
Quality of life in relation to prostate cancer will be assessed by the total score (ranging from 0 to 60) of the EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) questionnaire. Higher score means a worse outcome.
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 Aug 2026.
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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?
A study testing Total prostatectomy and Focal HIFU in people with Prostate Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 10 inclusion and 5 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 Aug 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 Guillaume PLOUSSARD, MD (+33 06 84 11 85 09, dr.gploussard@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in relation to prostate cancer (time frame: Month 6, month 12 and month 24). 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 Aug 2026.