Prostate CancerPhase 3CARLHA-2NCT04181203
Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy
A Phase 3 study testing Apalutamide, Salvage radiotherapy (SRT) and Luteinising Hormone Releasing Hormone agonist (LHRHa) in people with Prostate Cancer, run by UNICANCER at 15 sites in France.
Trial summary
This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Apalutamide, Salvage radiotherapy (SRT) and Luteinising Hormone Releasing Hormone agonist (LHRHa)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 15 sitesFrance
- Study dates
- 9 Jan 2020to 28 Dec 2033
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have signed a written informed consent form prior to any trial specific procedures
- Age ≥18 years old and ≤80 years old
- Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with radical prostatectomy
- Tumor stage pT2, pT3 or pT4* (*only in case of bladder neck involvement)
- Patients should have no clinical and radiological signs (18FCH-PET CT-scan or 68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse or pelvic nodal relapse (N1) detected on PET CT-scan can be randomized
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
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- PSA ≥0.2 ng/mL at the time of randomization with an elevation of PSA over three consecutive assays. PSA increases over a 1-month interval minimum
- At least 3 months between radical prostatectomy and randomization.
- High-risk features as defined by at least one of these characteristics: PSA at relapse >0.5 ng/mL or Gleason score >7 or tumor stage pT3b or resection margins R0 or PSA doubling time ≤6 months or pelvic lymph node relapse (N1, ≤5 lymph nodes)
- Adequate renal function: serum creatinine <1.5 x upper limit of normal (ULN) or a calculated corrected creatinine clearance ≥60 mL/min according to the Cockcroft-Gault formula, creatinemia <2 ULN
- Adequate hepatic function: total bilirubin ≤1.5 x ULN (unless documented Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN
- Patients with QTc prolongation <500 ms, inclusion should considered after close benefit/risk assessment and cardiologist advice
- Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
- Patients must be affiliated to the Social Security System
Who cannot join
- Previous treatment with hormone therapy for prostate cancer
- Histology other than adenocarcinoma
- Surgical or chemical castration
- Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years
- Previous pelvic radiotherapy
- More than 5 (>5) pelvic lymph node relapses
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- Paraaortic, thoracic or supaclavicular nodal relapse (M1a)
- History of Inflammatory bowel disease or any malabsorption syndrome or conditions that would interfere with enteral absorption
- Uncontrolled hypertension (defined as systolic blood pressure (BP) ≥140 mmHg or diastolic BP ≥90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- Clinically significant history of liver disease consistent with Child-Pugh class B or C
- History of seizure or condition that may pre-dispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
- Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
- Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g pulmonary embolism, cerebrovascular accident including transient ischemic attacks) or clinically significant ventricular arrhythmias within 6 months prior to randomization
- Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (e.g, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >500 ms at baseline
- Medications known to prolong QTc
- Known hypersensitivity to apalutamide or to any of its components
- Galactosemia, Glucose-galactose malabsorption or lactase deficiency
- Inability or willingness to swallow oral medication
- Individual deprived of liberty or placed under the authority of a tutor
- Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within the 30 days before inclusion
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Clinique Claude Bernard
Albi
Institut de Cancérologie de l'Ouest
Angers
Institut Bergonié
Bordeau
Centre Georges François LECLERC
Dijon
Centre Hospitalier Emile ROUX
Le Puy-en-Velay
Centre Oscar Lambret
Lille
Institut de Cancérologie de Montpellier
Montpellier
Centre Antoine Lacassagne
Nice
Institut Jean Godinot
Reims
Centre Henri Becquerel
Rouen
Institut de Cancérologie de l'Ouest
Saint-Herblain
Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez
Institut de Cancérologie Paris Nord
Sarcelles
Centre Paul STRAUSS
Strasbourg
Clinique Pasteur - ONCORAD
Toulouse
About this study
Official title: An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients
This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.
Read the detailed description
The purpose of the CARLHA-2 study is to determine if the combination of apalutamide with 6 months of LHRH agonists and radiotherapy results in an improvement of progression-free survival (PFS) in comparison to the combination of 6 months of LHRH agonists with radiotherapy in high-risk postprostatectomy biochemically relapsed prostate cancer patients.
Radical prostatectomy must have been done at least 6 months before inclusion and is not part of this study.
Patients after radical prostatectomy and biochemical relapse will be randomized in a 1:1 ratio to receive either 6 months of LHRH agonists + SRT or 6 months of LHRH agonists + SRT + 6 months of apalutamide.
The stratification variables include Gleason score, prostate-specific antigen (PSA), negative resection margins, extension to seminal vesicle(s), and PSA doubling time.
- Conditions
- Prostate Cancer
- Being tested
- Apalutamide, Salvage radiotherapy (SRT), Luteinising Hormone Releasing Hormone agonist (LHRHa)
- Keywords
- Apalutamide, Salvage radiotherapy, Radical prostatectomy, PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
Also called ARN-509
240 mg PO daily should start the same day as the first LHRHa administration for 6 months.
months.
Salvage radiotherapy (SRT)Radiation
The SRT treatment will be administered to a total dose of 66 Gy (in 33 fractions of 2 Gy) directed at the prostate bed with an additional 56.1 Gy (in 33 fractions of 1.7 Gy) directed at the pelvis region. The pelvis will be irradiated in all patients.
An additional simultaneously integrated boost of 69.3 Gy (in 33 fractions of 2.1 Gy) can be delivered to a local relapse based on Positron Emission Tomography - Computed Tomography (PET/CT) and Magnetic Resonance Imaging (MRI) images.
Luteinising Hormone Releasing Hormone agonist (LHRHa)Drug
Also called leuprolide, goserelin, triptorelin acetate
Doses of LHRHa may vary due to availability of different brand names and pharmaceutical forms. It will be left to the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| SRT + 6 months of LHRHa | Active comparator | * Treatment with LHRHa will start 4 weeks before the first RT fraction (i.e Day 1 of Week 1 of treatment period.) The total duration of the LHRHa treatment is 6 months.
* SRT will start 4 weeks after the first administration of LHRHa (i.e Day 1 of Week 5 of treatment period.). The total duration of SRT is 6.5 weeks. Receives: Radiation: Salvage radiotherapy (SRT); Drug: Luteinising Hormone Releasing Hormone agonist (LHRHa) |
| SRT + 6 months of LHRHa + 6 months of Apalutamide | Experimental | * Treatment with LHRHa will start 4 weeks before the first RT fraction (i.e Day 1 of Week 1 of treatment period.) The total duration of the LHRHa treatment is 6 months.
* Treatment with apalutamide (240 mg PO daily) should start the same day as the first LHRHa administration, for 6 months.
* SRT will start 4 weeks after the first administration of LHRHa (i.e Day 1 of Week 5 of treatment period.). The total duration of SRT is 6.5 weeks. Receives: Drug: Apalutamide; Radiation: Salvage radiotherapy (SRT); Drug: Luteinising Hormone Releasing Hormone agonist (LHRHa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization to the date of first evidence of loco-regional recurrences, or distant metastases, or death from any cause whichever occurs first, or the date of last known follow-up alive without any such events.
Measured: 5 years
Secondary outcomes (9)
Cancer-specific overall survival
Cancer-specific overall survival is defined as the time from the date of randomization to the date of death related to prostate cancer or the date of last known follow-up alive.
Measured: 10 years
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause or the date of last known follow-up alive.
Measured: 10 years
Biochemical relapse-free survival
Biochemical relapse-free survival will be retrospectively defined by the interval between the date of randomization and the date of the first PSA elevation following the 6-months treatment in both arms (PSA ≥0.5 ng/mL confirmed by two consecutive PSA increases over a 2-month interval).
Measured: 10 years
Time to castration resistance
The time to castration resistance is defined as the time from the date of randomization to the date of appearance of castration resistance defined in the European Association of Urology (EAU) guidelines.
Measured: 10 years
Adverse events graded according to the NCI Common Terminology Criteria for Adverse Events version 5.0
The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.
Measured: Throughout study completion, up to 10 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years
Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)
This EORTC prostate cancer specific questionnaire is intended to supplement the QLQ-C30.
The prostate cancer module is a 25-item questionnaire designed for use among patients with localized and metastatic prostate cancer. It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items) and sexual functioning (6 items). Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms.
Measured: At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years
International Index of Erectile Function (IIEF-5)
International Index of Erectile Function (IIEF-5) is multidimensional, self-administered questionnaire composed of 15 questions that examine the 4 main domains of male sexual function (erectile function [6 items], orgasmic function [2 items], sexual desire [2 items], and intercourse satisfaction [3 items]) and overall satisfaction (2 items). Using a 6-point Likert scale (questions 1 to 10) and 5-point Likert scale (questions 15 to 15), patients indicate the degree to which they have experienced symptoms. The total score for each domain can therefore classifies the severity of erectile dysfunction into five categories: no (score 26-30), mild (22-25), mild to moderate (17-21), moderate (11-16), and severe (1-10) erectile dysfunction.
Measured: At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years
Lawton Instrumental Activities of Daily Living (IADL) Scale
Lawton Instrumental Activities of Daily Living (IADL) Scale is a self-reported questionnaire to assess independent living skills for older adults. This questionnaire, composed of 31 questions organized into 8 domains (ability to use telephone, shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications, and ability to handle finances), is designed to identify improvement or deterioration of a person functioning over time. Each domain is scored 0-1 for a summary score ranging from 0 (low function, dependent) to 8 (high function, independent).
Measured: At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start9 Jan 2020
- Primary completion28 Sep 2028 (estimated)
- Study completion28 Dec 2033 (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 UNICANCERThe 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
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Responsible party
- Sponsor
- Investigators
- Stéphane SUPIOT, Principal investigator, Institut de Cancérologie de l'Ouest - Saint Herblain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181203
- Sponsor's protocol ID
- GETUG-AFU33 UC-0160/1702
- Other IDs
- 2017-000155-21, 2017
- Acronym
- CARLHA-2
- Status last verified
- Jun 2025
- First submitted
- 26 Nov 2019
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04181203
- Acronym / sponsor ID
- CARLHA-2 / GETUG-AFU33 UC-0160/1702
- Conditions
- Prostate Cancer
- Keywords
- Apalutamide, Salvage radiotherapy, Radical prostatectomy, PSA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 28 Sep 2028 (estimated)
- Study completion
- 28 Dec 2033 (estimated)
- First posted
- 29 Nov 2019 (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.
This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.
Detailed description
The purpose of the CARLHA-2 study is to determine if the combination of apalutamide with 6 months of LHRH agonists and radiotherapy results in an improvement of progression-free survival (PFS) in comparison to the combination of 6 months of LHRH agonists with radiotherapy in high-risk postprostatectomy biochemically relapsed prostate cancer patients.
Radical prostatectomy must have been done at least 6 months before inclusion and is not part of this study.
Patients after radical prostatectomy and biochemical relapse will be randomized in a 1:1 ratio to receive either 6 months of LHRH agonists + SRT or 6 months of LHRH agonists + SRT + 6 months of apalutamide.
The stratification variables include Gleason score, prostate-specific antigen (PSA), negative resection margins, extension to seminal vesicle(s), and PSA doubling time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRT + 6 months of LHRHa | Active comparator | Radiation: Salvage radiotherapy (SRT), Drug: Luteinising Hormone Releasing Hormone agonist (LHRHa)* Treatment with LHRHa will start 4 weeks before the first RT fraction (i.e Day 1 of Week 1 of treatment period.) The total duration of the LHRHa treatment is 6 months. * SRT will start 4 weeks after the first administration of LHRHa (i.e Day 1 of Week 5 of treatment period.). The total duration of SRT is 6.5 weeks. |
| SRT + 6 months of LHRHa + 6 months of Apalutamide | Experimental | Drug: Apalutamide, Radiation: Salvage radiotherapy (SRT), Drug: Luteinising Hormone Releasing Hormone agonist (LHRHa)* Treatment with LHRHa will start 4 weeks before the first RT fraction (i.e Day 1 of Week 1 of treatment period.) The total duration of the LHRHa treatment is 6 months. * Treatment with apalutamide (240 mg PO daily) should start the same day as the first LHRHa administration, for 6 months. * SRT will start 4 weeks after the first administration of LHRHa (i.e Day 1 of Week 5 of treatment period.). The total duration of SRT is 6.5 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have signed a written informed consent form prior to any trial specific procedures
- Age ≥18 years old and ≤80 years old
- Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with radical prostatectomy
- Tumor stage pT2, pT3 or pT4* (*only in case of bladder neck involvement)
- Patients should have no clinical and radiological signs (18FCH-PET CT-scan or 68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse or pelvic nodal relapse (N1) detected on PET CT-scan can be randomized
Key exclusion criteria (20 listed)
- Previous treatment with hormone therapy for prostate cancer
- Histology other than adenocarcinoma
- Surgical or chemical castration
- Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years
- Previous pelvic radiotherapy
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 |
|---|---|---|
| ApalutamideAlso: ARN-509240 mg PO daily should start the same day as the first LHRHa administration for 6 months. months. | Drug | SRT + 6 months of LHRHa + 6 months of Apalutamide |
| Salvage radiotherapy (SRT)The SRT treatment will be administered to a total dose of 66 Gy (in 33 fractions of 2 Gy) directed at the prostate bed with an additional 56.1 Gy (in 33 fractions of 1.7 Gy) directed at the pelvis region. The pelvis will be irradiated in all patients. An additional simultaneously integrated boost of 69.3 Gy (in 33 fractions of 2.1 Gy) can be delivered to a local relapse based on Positron Emission Tomography - Computed Tomography (PET/CT) and Magnetic Resonance Imaging (MRI) images. | Radiation | SRT + 6 months of LHRHa, SRT + 6 months of LHRHa + 6 months of Apalutamide |
| Luteinising Hormone Releasing Hormone agonist (LHRHa)Also: leuprolide, goserelin, triptorelin acetateDoses of LHRHa may vary due to availability of different brand names and pharmaceutical forms. It will be left to the discretion of the investigator. | Drug | SRT + 6 months of LHRHa, SRT + 6 months of LHRHa + 6 months of Apalutamide |
Primary outcome
Progression-free survival (PFS)
Time frame: 5 years
PFS is defined as the time from the date of randomization to the date of first evidence of loco-regional recurrences, or distant metastases, or death from any cause whichever occurs first, or the date of last known follow-up alive without any such events.
9 secondary outcomes
Cancer-specific overall survival
Time frame: 10 years
Overall survival (OS)
Time frame: 10 years
Biochemical relapse-free survival
Time frame: 10 years
Time to castration resistance
Time frame: 10 years
Adverse events graded according to the NCI Common Terminology Criteria for Adverse Events version 5.0
Time frame: Throughout study completion, up to 10 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years
Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)
Time frame: At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years
International Index of Erectile Function (IIEF-5)
Time frame: At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years
Lawton Instrumental Activities of Daily Living (IADL) Scale
Time frame: At baseline, 3 months, 6 months, every 6 months up to 5 years then every 12 months up to 10 years
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 30 Jul 2025.
- 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. This study is not recruiting at the moment.
Stéphane SUPIOT principal investigator
Institut de Cancérologie de l'Ouest - Saint Herblain
15 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 Apalutamide, Salvage radiotherapy (SRT) and Luteinising Hormone Releasing Hormone agonist (LHRHa) in people with Prostate Cancer, run by UNICANCER at 15 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 14 inclusion and 20 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Progression-free survival (PFS) (time frame: 5 years). 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 30 Jul 2025.