Prostate CancerPhase 3HIFUSANCT03531099
Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU (High Intensity Focused Ultrasound) Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer
A Phase 3 study testing treatment with focal HIFU, PSA dosage and MRI in people with Prostate Cancer, run by Hospices Civils de Lyon at 14 sites in France.
Trial summary
The percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- treatment with focal HIFU, PSA dosage and MRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 14 sitesFrance
- Study dates
- 2 Oct 2018to 2 Oct 2026
- Phase
- Phase 3
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
- Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score > 14.
- Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
- Only one Target tumor on MRI on a maximum of 2 contigous sextants. Case allowed:
- If more than one target tumor on MRI, only one of them must be confirmed by targeted prostate biopsies.
- If no target tumor on MRI, only 2 contigous sextants must be positive on prostate biopsies
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- A maximum tumor length> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or MRI/Ultrasound Fusion-Guided Prostate Biopsy).
- Gleason 6 score (risk group 1 of the D'Amico classification).
- Tumor positioned so that a safety distance of at least 9 mm from external sphincter can be defined during HIFU-FOCAL treatment in prostate tissue around the target.
- PSA ≤ 15ng / ml.
- Patient affiliated with health insurance or beneficiary of an equivalent plan.
Who cannot join
- Contraindications to treatment with HIFU-F:
- Tumor not accessible.
- Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
- History of pelvic irradiation
- Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
- Fistula of the urinary tract or rectum.
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- Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
- Anatomical abnormality of the rectum or rectal mucosa.
- Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
- History of intestinal inflammatory pathology.
- Uro-genital infection in progress (the infection to be treated before HIFU treatment).
- Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
- Allergy to latex.
- Thickness of the rectal wall> 10mm.
- TURP indication. Bladder neck incision is allowed .
- Patient with a medical contraindication to Sonovue® injection.
- Patient with a medical contraindication on MRI.
- Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
- History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
- History of sclerosis of the bladder neck or urethral stenosis.
- Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy if randomized in HIFU-F arm).
- Patients with unstable neurological pathology.
- Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
- Legal person protected by law.
- Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Polyclinique du parc Rambot
Aix-en-Provence, 13100
Clinique Saint-Vincent
Besançon, 25044
Service d'Urologie, Clinique Tivoli Ducos
Bordeaux, 33000
Groupe Hospitalier Pellegrin - CHU
Bordeaux, 33076
Service d'Urologie, CHU de Guebwiller Colmar
Colmar, 68024
Service d'Urologie CHRU de Lille, Hôpital HURIEZ
Lille, 59000
Service d'Urologie Générale de Santé - Hôpital Privé La Louvière
Lille, 59000
Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,
Lyon, 69437
Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord
Marseille, 13915
Département d'Urologie, Institut Montsouris
Paris, 75014
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Clinique Urologique Nantes Atlantis
Saint-Herblain, 44800
Service d'Urologie, Hôpital Foch
Suresnes, 92150
CHU de Toulouse - Hôpital de Rangueil
Toulouse, 31400
About this study
Official title: Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer
The percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. When a tumor of this type is identified, radical prostatectomy remains the reference treatment, but this treatment is not without side effects. Active surveillance is a strategy which aims at detecting an early development of the cancerous disease in order to propose curative treatment in a timely manner and thus improve specific survival. Patients are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen) assay. Active surveillance remains difficult to manage psychologically for both the patient and the practitioner, because of the lack of treatment on the one hand and a rate of non-curable cancers close to 50% when signs of progression trigger a radical treatment.
The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the cancer without causing side effects in contrast to radical treatments. It is in this sense that it is positioned both as an alternative to radical surgery and as an alternative to active surveillance.
- Conditions
- Prostate Cancer
- Being tested
- treatment with focal HIFU, PSA dosage, MRI, Questionnaires, Prostatic biopsies
- Keywords
- Prostate cancer, HIFU focal, adverse effect, low risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with focal HIFUProcedure or surgery
HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed.
PSA dosageBiological
PSA dosage will be regularly performed during patient follow up thanks to blood sampling.
MRIDevice
MRI exam will be regularly performed during patient follow up.
QuestionnairesOther
Patients will have to complete five questionnaires during their follow up : QLQ-C30 (Quality of Life questionnaire), EPIC-26 (The Expanded Prostate Cancer Index Composite), IPSS (International Prostate Score Symptom), IIEF-5 (The International Index of Erectile Function), STAI-YB (State-Trait Anxiety Inventory)
Prostatic biopsiesProcedure or surgery
Prostatic biopsies will be regularly performed during patient follow up.
| Study group | Role | What they receive |
|---|---|---|
| HIFU treatment | Experimental | 65 patients will receive the immediate treatment with focal HIFU in order to destroy the cancer without causing side effects. HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed.
Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up. Receives: Procedure: treatment with focal HIFU; Biological: PSA dosage; Device: MRI; Other: Questionnaires; Procedure: Prostatic biopsies |
| Active surveillance | Active comparator | 65 patients will be randomized to active surveillance and will have exactly the same follow-up as treated patients excepting the HIFU treatment.
Active surveillance is a therapeutic option that shifts the eventual moment of curative treatment while remaining within a window of curability of the disease.
Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up. Receives: Biological: PSA dosage; Device: MRI; Other: Questionnaires; Procedure: Prostatic biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient proportion who needed to seek radical treatment
The primary endpoint is the comparison between the 2 groups of the proportion of patient converting to a radical treatment at 48 months of follow-up. Conversion to a radical treatment is define as a medical decision based on the following criteria:
- An increase in Gleason score to a score 7 (3 + 4) with bilateral involvement (Gleason 6 or 7).
- An increase in the Gleason score to a score 7 (3 + 4) with tumor whose location is not compatible with a focal treatment (impossibility to apply safety margins of 9mm).
- An increase in Gleason score to a score of 7 (4 + 3) or higher.
- Risk of lymph node invasion> 5% (calculated with the MSKCC nomogram)
- An extension of the tumor beyond the prostatic capsule (MRI and / or biopsies).
- Appearance of pelvic ganglion metastases.
Measured: 48 month
Secondary outcomes (23)
proportion of patients needing additional treatment
The objective is to compare between the 2 groups the proportion of patients needing additional treatment (focal or radical) at 24 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, focal treatment for patients in the active surveillance group or additional treatment for patients in the treatment group.
Measured: 24 months
proportion of patients needing additional treatment
The objective is to compare between the 2 groups the proportion of patients needing additional treatment (focal or radical) at 48 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, focal treatment for patients in the active surveillance group or additional treatment for patients in the treatment group.
Measured: 48 months
rate of positive biopsies
The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the oncological evolution at 24 months.
Measured: 24 months
rate of positive biopsies
The rate of positive biopsies in the untreated lobe and treated lobe will be measured and will be used to evaluate the oncological evolution at 48 months.
Measured: 48 months
clinically significant cancer rate
The clinically significant cancer rate (Gleason 7 or invasion of more than 3 biopsies or invasion> 3 mm regardless of Gleason) in the untreated lobe and the treated lobe will be measured and will be used to evaluate the oncological evolution at 24 months.
Measured: 24 months
clinically significant cancer rate
The clinically significant cancer rate (Gleason 7 or invasion of more than 3 biopsies or invasion> 3 mm regardless of Gleason) in the untreated lobe and the treated lobe will be measured and will be used to evaluate the oncological evolution at 48 months.
Measured: 48 months
Gleason score
Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the oncological evolution at 24 months.
Measured: 24 months
Gleason score
Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the oncological evolution at 48 months.
Measured: 48 months
Appearance of another cancerous focus in the other half of the prostate
Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the oncological evolution at 24 months.
Measured: 24 months
Appearance of another cancerous focus in the other half of the prostate
Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the oncological evolution at 48 months.
Measured: 48 months
Appearance of metastases
Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the oncological evolution at 24 months.
Measured: 24 months
Appearance of metastases
Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the oncological evolution at 48 months.
Measured: 48 months
Appearance of an extra capsular extension
Appearance of an extra capsular extension will be supervised and will be used to evaluate the oncological evolution at 24 months.
Measured: 24 months
Appearance of an extra capsular extension
Appearance of an extra capsular extension will be supervised and will be used to evaluate the oncological evolution at 48 months.
Measured: 48 months
Overall survival
Overall survival at 48 months will be measured from the date of inclusion to the date of death, all causes of death combined or the date of last new or point date to 48 months.
Measured: 48 months
Prostate cancer specific survival
Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of death related to prostate cancer or the date of last new or point date to 48 months
Measured: 48 months
Recurrence free survival
Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of first metastasis , or the date of last new or point date to 48 months
Measured: 48 months
Proportion of serious adverse effect
comparison between the 2 groups of the proportion of serious adverse effect at 48 months
Measured: 48 months
Quality of life score
quality of life will be compared between the two groups and assessed using the QLQC30 questionnaire
Measured: over the 48 months
EPIC-26 score
urinary function will be compared between the two groups and assessed using the EPIC-26 questionnaire.
Measured: over the 48 months
IPSS score
urinary function will be compared between the two groups and assessed using the IPSS questionnaire.
Measured: over the 48 months
IIEF-5 score
Sexual function will be compared between the two groups and assessed using the IIEF-5 questionnaire
Measured: over the 48 months
STAi-YB score
Anxiety will be compared between the two groups and assessed using the STAi-YB questionnaire
Measured: Over the 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start2 Oct 2018
- Primary completion2 Oct 2026 (estimated)
- Study completion2 Oct 2026 (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 Hospices Civils de LyonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531099
- Sponsor's protocol ID
- 69HCL18_0203
- Other IDs
- 2018-A01024-51
- Acronym
- HIFUSA
- Status last verified
- Aug 2026
- First submitted
- 9 May 2018
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03531099
- Acronym / sponsor ID
- HIFUSA / 69HCL18_0203
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, HIFU focal, adverse effect, low risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 21 May 2018 (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 percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. When a tumor of this type is identified, radical prostatectomy remains the reference treatment, but this treatment is not without side effects. Active surveillance is a strategy which aims at detecting an early development of the cancerous disease in order to propose curative treatment in a timely manner and thus improve specific survival. Patients are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen) assay. Active surveillance remains difficult to manage psychologically for both the patient and the practitioner, because of the lack of treatment on the one hand and a rate of non-curable cancers close to 50% when signs of progression trigger a radical treatment.
The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the cancer without causing side effects in contrast to radical treatments. It is in this sense that it is positioned both as an alternative to radical surgery and as an alternative to active surveillance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIFU treatment | Experimental | Procedure: treatment with focal HIFU, Biological: PSA dosage, Device: MRI, Other: Questionnaires, Procedure: Prostatic biopsies65 patients will receive the immediate treatment with focal HIFU in order to destroy the cancer without causing side effects. HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up. |
| Active surveillance | Active comparator | Biological: PSA dosage, Device: MRI, Other: Questionnaires, Procedure: Prostatic biopsies65 patients will be randomized to active surveillance and will have exactly the same follow-up as treated patients excepting the HIFU treatment. Active surveillance is a therapeutic option that shifts the eventual moment of curative treatment while remaining within a window of curability of the disease. Patients randomized in this arm will also have PSA dosage, MRI exam, questionnaires and prostatic biopsies during their follow up. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
- Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score > 14.
- Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
- PSA ≤ 15ng / ml.
- Patient affiliated with health insurance or beneficiary of an equivalent plan.
Key exclusion criteria (25 listed)
- Contraindications to treatment with HIFU-F:
- TURP indication. Bladder neck incision is allowed .
- Patient with a medical contraindication to Sonovue® injection.
- Patient with a medical contraindication on MRI.
- Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
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 |
|---|---|---|
| treatment with focal HIFUHIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. | Procedure or surgery | HIFU treatment |
| PSA dosagePSA dosage will be regularly performed during patient follow up thanks to blood sampling. | Biological | Active surveillance, HIFU treatment |
| MRIMRI exam will be regularly performed during patient follow up. | Device | Active surveillance, HIFU treatment |
| QuestionnairesPatients will have to complete five questionnaires during their follow up : QLQ-C30 (Quality of Life questionnaire), EPIC-26 (The Expanded Prostate Cancer Index Composite), IPSS (International Prostate Score Symptom), IIEF-5 (The International Index of Erectile Function), STAI-YB (State-Trait Anxiety Inventory) | Other | Active surveillance, HIFU treatment |
| Prostatic biopsiesProstatic biopsies will be regularly performed during patient follow up. | Procedure or surgery | Active surveillance, HIFU treatment |
Primary outcome
patient proportion who needed to seek radical treatment
Time frame: 48 month
The primary endpoint is the comparison between the 2 groups of the proportion of patient converting to a radical treatment at 48 months of follow-up. Conversion to a radical treatment is define as a medical decision based on the following criteria: * An increase in Gleason score to a score 7 (3 + 4) with bilateral involvement (Gleason 6 or 7). * An increase in the Gleason score to a score 7 (3 + 4) with tumor whose location is not compatible with a focal treatment (impossibility to apply safety margins of 9mm). * An increase in Gleason score to a score of 7 (4 + 3) or higher. * Risk of lymph node invasion> 5% (calculated with the MSKCC nomogram) * An extension of the tumor beyond the prostatic capsule (MRI and / or biopsies). * Appearance of pelvic ganglion metastases.
23 secondary outcomes
proportion of patients needing additional treatment
Time frame: 24 months
proportion of patients needing additional treatment
Time frame: 48 months
rate of positive biopsies
Time frame: 24 months
rate of positive biopsies
Time frame: 48 months
clinically significant cancer rate
Time frame: 24 months
clinically significant cancer rate
Time frame: 48 months
Gleason score
Time frame: 24 months
Gleason score
Time frame: 48 months
Appearance of another cancerous focus in the other half of the prostate
Time frame: 24 months
Appearance of another cancerous focus in the other half of the prostate
Time frame: 48 months
Appearance of metastases
Time frame: 24 months
Appearance of metastases
Time frame: 48 months
Appearance of an extra capsular extension
Time frame: 24 months
Appearance of an extra capsular extension
Time frame: 48 months
Overall survival
Time frame: 48 months
Prostate cancer specific survival
Time frame: 48 months
Recurrence free survival
Time frame: 48 months
Proportion of serious adverse effect
Time frame: 48 months
Quality of life score
Time frame: over the 48 months
EPIC-26 score
Time frame: over the 48 months
IPSS score
Time frame: over the 48 months
IIEF-5 score
Time frame: over the 48 months
STAi-YB score
Time frame: Over the 48 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 4 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing treatment with focal HIFU, PSA dosage and MRI in people with Prostate Cancer, run by Hospices Civils de Lyon at 14 sites 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 11 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 4 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 14 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient proportion who needed to seek radical treatment (time frame: 48 month). 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 4 Aug 2026.