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AzTrials

Metastatic Hormone-sensitive Prostate CancerPhase 3REINFORCENCT07333066

Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.

A Phase 3 study testing Apalutamide (Erleada™) 60 mg or 240 mg tablets and Docetaxel in people with Metastatic Hormone-sensitive Prostate Cancer, run by Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD at 56 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not achieve deep PSA response (≤0,2 ng/ml or PSA90 response in combination with a PSA ≤ 4 ng/ml)… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Apalutamide (Erleada™) 60 mg or 240 mg tablets and Docetaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
56 sitesin 5 countries
Study dates
5 Jun 2026to 31 Mar 2030
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent. Each patient must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures, required for the study, and is willing to participate in the study.
  • Patient must be a man ≥18 years of age.
  • Histologically or cytologically confirmed adenocarcinoma of prostate.
  • Metastatic hormone-sensitive prostate cancer.
  • PSA >5 ng/ml at diagnosis of metastatic disease.
  • Patients eligible to continue treatment with apalutamide and ADT and without contra-indication to receive docetaxel.
Show all 21Show fewer
  • Patients with at least 24 weeks and no more than 30 weeks of apalutamide.
  • Patients with a maximum of 12 weeks ADT before apalutamide initiation.
  • Lack of achievement of deep PSA response after 24 weeks and no more than 30 weeks of apalutamide. Deep PSA response is defined as PSA ≤ 0.2 ng/ml or PSA response ≥ 90% in combination with a PSA ≤4 ng/ml. Therefore, a non-deep PSA response is defined as PSA > 0.2 ng/ml in combination with a PSA response < 90%, or a PSA response ≥90% in combination with a PSA > 4 ng/ml.
  • Patients who have not progressed to apalutamide.
  • Patients that are tolerating adequately apalutamide 240 mg daily and with no toxicity higher than G1 at inclusion.
  • Be able to swallow whole apalutamide film-coated tablets.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Clinical laboratory values at screening:
  • hemoglobin ≥10.0 g/dL,
  • absolute neutrophil count ≥1.5 × 10*9/L,
  • platelet count ≥100 × 109/L, The patient must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at screening
  • serum alanine aminotransferase and/or aspartate transaminase ≤1.5 × the upper limit of normal (ULN),
  • total bilirubin ≤ ULN,
  • creatinine ≤2.0 × ULN
  • Sexually active men must agree to use an external condom as an effective barrier method and refrain from sperm donation, and their female partners of childbearing potential must practice a highly effective method of contraception during and for 3 months after treatment with apalutamide and for 6 months after treatment with docetaxel.

Who cannot join

  • Presence of neuroendocrine histology.
  • Apalutamide treatment started more than 30 weeks before inclusion.
  • Progression disease by any means, including radiographic, clinical or serological at inclusion.
  • Patient who achieves deep PSA response on apalutamide treatment before randomization.
  • Previous androgen-pathway receptor inhibitors, including enzalutamide, darolutamide, abiraterone or other ARPI. Previous treatment with first generation antiandrogens (i.e. bicalutamide) is allowed.
  • Chemotherapy or immunotherapy for prostate cancer before randomization.
Show all 24Show fewer
  • Treatment with radiotherapy (external-beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization.
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.
  • Contraindication to both computed tomography and magnetic resonance imaging contrast agent.
  • Prolonged QT interval defined as QTcF ≥ 480 ms at screening, based on the mean of triplicate 12-lead ECGs performed after at least 5 minutes of rest. Patients with congenital long QT syndrome will also be excluded.
  • Any of the following within 6 months before randomization:
  • stroke,
  • myocardial infarction,
  • severe or unstable angina pectoris,
  • uncontrolled arrhythmia,
  • coronary or peripheral artery bypass graft, or
  • congestive heart failure (New York Heart Association class III or IV)
  • Peripheral neuropathy ≥ grade 2.
  • Uncontrolled hypertension, indicated by resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite medical management.
  • Prior malignancy, except for adequately treated basal-cell or squamous-cell carcinoma of the skin or superficial bladder cancer that had not spread behind the connective-tissue layer (i.e., stage pTis, pTa, or pT1) or any cancer for which treatment had been completed ≥5 years before randomization and from which the patient was disease-free.
  • A gastrointestinal disorder or procedure that was expected to interfere significantly with absorption of study drug.
  • Active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment.
  • Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever was longer) or concomitant participation in another clinical study with investigational medicinal products.
  • Any other serious or unstable illness or medical, social, or psychological condition that could jeopardize the safety of the patient and/or their compliance with study procedures or might interfere with their participation in the study or evaluation of the study results.

Trial locations and contacts

56 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

GUARD contact

+34 93 452 79 18

info@guardconsortium.org

56 sites in 5 countries

Spain21 sites, 21 recruiting

  • Hospital Universitari Vall d´Hebron

    Barcelona, Bacelona

    Dolores Fenor de la Maza, MD

    Dolores Fenor de la Maza, MD

    Not yet recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona

    Marta García de Herreros, MD

    Marta García de Herreros, MD

    Not yet recruiting

  • Hospital del Mar

    Barcelona, Barcelona

    Alejo Rodríguez-Vida, MD

    Alejo Rodríguez-Vida, MD

    Not yet recruiting

  • Hospital Santa Creu i Sant Pau

    Barcelona, Barcelona

    Mikel Portu, MD

    Mikel Portu, MD

    Not yet recruiting

  • ICO Badalona

    Barcelona, Barcelona

    Albert Font, MD

    Albert Font, MD

    Not yet recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada

    Raquel Luque, MD

    Raquel Luque, MD

    Not yet recruiting

  • Institut Català d'Oncologia (ICO) L´Hospitalet de Llobregat

    L'Hospitalet de Llobregat, Barcelona

    Jose María Piulats, MD

    Jose María Piulats, MD

    Not yet recruiting

  • Hospital Universitario 12 Octubre

    Madrid, Madrid

    Enrique Gonzalez-Billalabeitia, MD

    Enrique Gonzalez-Billalabeitia, MD

    Recruiting

  • Hospital Universitario Clínico San Carlos

    Madrid, Madrid

    Natalia Vidal, MD

    Natalia Vidal, MD

    Not yet recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid

    Alvaro Pinto, MD

    Alvaro Pinto, MD

    Not yet recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid

    Teresa Alonso, MD

    Teresa Alonso, MD

    Not yet recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga

    Bernardo Herrera, MD

    Bernardo Herrera, MD

    Not yet recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia, Murcia

    Antonio Rosino, MD

    Antonio Rosino, MD

    Not yet recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria

    Juan Diego Cacho, MD

    Juan Diego Cacho, MD

    Not yet recruiting

  • Hospital Clínico Universitario Santiago de Compostela

    Santiago de Compostela, La Coruña

    Urbano Anido, MD

    Urbano Anido, MD

    Not yet recruiting

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla

    Alberto Torres, MD

    Alberto Torres, MD

    Not yet recruiting

  • Fundación Instituto Valenciano de Oncología

    Valencia, Valencia

    David Llorente, MD

    David Llorente, MD

    Not yet recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia

    Isabel Chirivella, MD

    Isabel Chirivella, MD

    Not yet recruiting

  • Hospital General Universitario de Valencia

    Valencia, Valencia

    Cristina Caballero, MD

    Cristina Caballero, MD

    Not yet recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid

    Ricardo Sánchez- Escribano, MD

    Ricardo Sánchez- Escribano, MD

    Not yet recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon

    Carmen Santander, MD

    Carmen Santander, MD

    Not yet recruiting

Other trials in Spain

France20 sites, 20 recruiting

  • CH Bayonne

    Bayonne

    Louis Francois, MD

    Louis Francois, MD

    Not yet recruiting

  • Institut Bergonié

    Bordeaux

    Guilhem Roubaud, MD

    Guilhem Roubaud, MD

    Not yet recruiting

  • CHP Brest - Pasteur

    Brest

    Ali Hasbini, MD

    Ali Hasbini, MD

    Not yet recruiting

  • Hôpital Henri-Mondor

    Créteil

    Alexandre Ingels, MD

    Alexandre Ingels, MD

    Not yet recruiting

  • GHM Cancérologie - Institut Daniel Hollard

    Grenoble

    Valentine Ruste, MD

    Valentine Ruste, MD

    Not yet recruiting

  • Hôpital Franco-Britannique

    Levallois-Perret

    Caroline Pettenati, MD

    Caroline Pettenati, MD

    Not yet recruiting

  • GHBS - Hôpital du Scorff

    Lorient

    Marie L'Huissier, MD

    Marie L'Huissier, MD

    Not yet recruiting

  • Centre De Cancérologie Du Grand Montpellier

    Montpellier

    Emmanuel Nicolas, MD

    Emmanuel Nicolas, MD

    Not yet recruiting

  • Institut du Cancer de Montpellier - Val d'Aurelle (ICM)

    Montpellier

    Diego Tosi, MD

    Diego Tosi, MD

    Not yet recruiting

  • CHU Nîmes

    Nîmes

    Nadine Houede, MD

    Nadine Houede, MD

    Not yet recruiting

  • Hospices Civils de Lyon - HCL

    Paris

    Denis Maillet, MD

    Denis Maillet, MD

    Not yet recruiting

  • Hôpital Européen Georges Pompidou

    Paris

    Charles Dariane, MD

    Charles Dariane, MD

    Not yet recruiting

  • Hôpital Paris Saint-Joseph

    Paris

    Carole Helissey, MD

    Carole Helissey, MD

    Not yet recruiting

  • Hôpital Pitié-Salpêtrière

    Paris

    Paul Gougis, MD

    Paul Gougis, MD

    Not yet recruiting

  • CHU Poitiers

    Poitiers

    Sheik Emambux, MD

    Sheik Emambux, MD

    Not yet recruiting

  • Institut Godinot

    Reims

    Jean-Christophe Eymard, MD

    Jean-Christophe Eymard, MD

    Not yet recruiting

  • CHU de Rennes

    Rennes

    Romain Mathieu, MD

    Romain Mathieu, MD

    Not yet recruiting

  • Polyclinique Saint Georges

    Saint-Georges-de-Didonne

    Nice Ophélie Cassuto, MD

    Nice Ophélie Cassuto, MD

    Not yet recruiting

  • CHP Saint Gregoire

    Saint-Grégoire

    Aurelien Gobert, MD

    Aurelien Gobert, MD

    Not yet recruiting

  • Hôpital Foch

    Suresnes

    Yann Vano, MD

    Yann Vano, MD

    Not yet recruiting

Other trials in France

Germany9 sites, 9 recruiting

  • Facharztzentrum für Urologie, Uro-Onkologie

    Berlin

    Andreas Haßler, MD

    Andreas Haßler, MD

    Not yet recruiting

  • Praxis Berlin / FASANUS - Urologie - Andrologie - Uro-Onkologie

    Berlin

    Andreas Maxeiner, MD

    Andreas Maxeiner, MD

    Not yet recruiting

  • Johanniter-Krankenhaus Bonn-Gronau

    Bonn

    Carsten Ohlmann, MD

    Carsten Ohlmann, MD

    Not yet recruiting

  • SRH Wald-Klinikum Gera

    Gera

    Susan Foller, MD

    Susan Foller, MD

    Not yet recruiting

  • University Hospital Göttingen

    Göttingen

    Arne Strauß, MD

    Arne Strauß, MD

    Not yet recruiting

  • Urologische Facharztpraxis Saale

    Halle

    Sandra Seseke, MD

    Sandra Seseke, MD

    Not yet recruiting

  • Urologicum Karlsruhe MVZ

    Karlsruhe

    Christoph Vierneisel, MD

    Christoph Vierneisel, MD

    Not yet recruiting

  • Klinikum Recklinghausen

    Recklinghausen

    Marco Brock, MD

    Marco Brock, MD

    Not yet recruiting

  • University Hospital Rostock

    Rostock

    Angelika Borkowetz, MD

    Angelika Borkowetz, MD

    Not yet recruiting

Other trials in Germany

Italy5 sites, 5 recruiting

  • ARNAS Garibaldi - Catania

    Catania

    Roberto Bordonaro, MD

    Roberto Bordonaro, MD

    Not yet recruiting

  • Hospital Riuniti di Foggia - Foggia

    Foggia

    Vincenza Conteduca, MD

    Vincenza Conteduca, MD

    Not yet recruiting

  • National Instute of Oncology - Milan

    Milan

    Giuseppe Procopio, MD

    Giuseppe Procopio, MD

    Not yet recruiting

  • Policlinico Gemelli Hospital - Rome

    Roma

    Roberto lacovelli, MD

    Roberto Iacovelli, MD

    Not yet recruiting

  • Policlinico Umberto I - Rome

    Roma

    Daniele Santini, MD

    Daniele Santini, MD

    Not yet recruiting

Other trials in Italy

Portugal1 site, 1 recruiting

  • ULS Alto Ave

    Guimarães

    Carolina Carvalho, MD

    Carolina Carvalho, MD

    Not yet recruiting

Other trials in Portugal

About this study

This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not achieve deep PSA response (≤0,2 ng/ml or PSA90 response in combination with a PSA ≤ 4 ng/ml) after initial treatment with apalutamide and ADT. A non-deep PSA response is defined as PSA > 0.2 ng/ml in combination with a PSA response < 90%, or a PSA response ≥90% in combination with a PSA > 4 ng/ml.

Read the detailed description

Approximately 320 patients will be randomized in a 1:1 ratio to the treatments as specified below:

  • Arm A (experimental arm): docetaxel (75 mg/m2 every three weeks), for 6 planned cycles, plus apalutamide and ADT (240 mg, oral single daily dose).
  • Arm B (control arm): continuation of SOC treatment with apalutamide and ADT (240 mg, oral single daily dose).

Randomization will be stratified by 3 factors:

  • Metastasis timing (synchronous vs metachronous)
  • Visceral metastasis at diagnosis (yes vs no)
  • PSA at study inclusion (≤ 4 ng/ml vs >4 ng/ml) An IDMC will be established for regular safety monitoring, for the pre-planned interim analysis and the PK sub-study when available. The composition, role, responsibilities and procedures of the IDMC will be detailed in the IDMC Charter.
Being tested
Apalutamide (Erleada™) 60 mg or 240 mg tablets, Docetaxel
Keywords
Prostate Cancer, Apalutamide, Hormone-sensitive prostate cancer, Deep PSA response
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apalutamide (Erleada™) 60 mg or 240 mg tabletsDrug

    The dose of 240 mg (four 60 mg tablets or one single 240 mg tablet) daily of apalutamide is the recommended dose in the SmPC.

    ADT will be chosen and administered according to standard clinical practice at each participating site and has not been included in the table below.

  • DocetaxelDrug

    The recommended dose of docetaxel is 75 mg/m2 day 1 every 21 days. Six cycles of docetaxel will be administered.

Study groups in NCT07333066
Study groupRoleWhat they receive
Arm A (experimental arm)ExperimentalDocetaxel (75 mg/m2 every three weeks), for 6 planned cycles, plus apalutamide (240 mg, oral single daily dose) and ADT.
Receives: Drug: Apalutamide (Erleada™) 60 mg or 240 mg tablets; Drug: Docetaxel
Arm B (control arm)No interventionContinuation of SOC treatment with apalutamide (240 mg, oral single daily dose) and ADT.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free Survival (EFS)

    Event-free survival is defined as the time from randomization to occurrence of the following events, whichever occurs first in each treatment arm: PSA progression or radiographic progression of soft-tissue, visceral, or bone lesions or death from any cause.

    Measured: 48 months

Secondary outcomes (16)

  1. Time to castration resistance

    Time to castration resistance is defined as time from randomization to radiographic disease progression, PSA progression per PCWG3 criteria, or symptomatic skeletal event (defined as radiation to bone, pathologic fracture, spinal cord compression, or surgery to bone due to symptoms), whichever occurred first in each treatment arm.

    Measured: 48 months

  2. Radiographic progression-free survival (rPFS)

    Radiographic Progression-Free Survival is defined as the time from randomization to the first documented evidence of radiographic disease progression, as assessed by the investigator per Prostate Cancer Working Group 3 (PCWG3) criteria for bone lesions and RECIST v1.1 for soft tissue lesions, or death from any cause, whichever occurs first in each treatment arm.

    Measured: 48 months

  3. PSA progression-free survival

    PSA progression-free survival (PSA-PFS) is defined according to PCWG3 criteria as the time from randomization to the date of PSA progression (a ≥25% increase and an absolute increase of ≥2 ng/mL from nadir, confirmed by a second value ≥3 weeks later) or death from any cause, whichever occurs first in each treatment arm.

    Measured: 48 months

  4. Overall survival

    Overall survival is defined as time from randomization to date of death from any cause in each treatment arm.

    Measured: 48 months

  5. Time to subsequent treatment

    Time to subsequent treatment is defined as the time from randomization to the initiation of the first subsequent systemic anticancer therapy after study drugs discontinuation, or death, whichever occurs first in each treatment arm.

    Measured: 48 months

  6. Deep PSA response rate at 6 months in each treatment arm.

    Deep PSA response is defined as achieving a prostate-specific antigen (PSA) level ≤0.2 ng/mL or PSA Response ≥90% in combination with a PSA ≤ 4 ng/ml.

    Measured: 6 months

  7. Ultradeep PSA response rate at 6 months in each treatment arm.

    Ultradeep PSA response 1 is defined as achieving a prostate-specific antigen (PSA) level between 0.2 and 0.02 ng/mL.

    Ultradeep PSA response 2 is defined as achieving a prostate-specific antigen (PSA) level ≤ 0.02 ng/mL.

    Measured: 6 months

  8. Symptomatic skeletal event-free survival

    Symptomatic skeletal event-free survival (SSE-FS) is defined as the time from randomization to the first occurrence of a symptomatic skeletal event (defined as radiation to bone, pathologic fracture, spinal cord compression, or surgery to bone due to symptoms) or death from any cause, whichever occurred first in each treatment arm.

    Measured: 48 months

  9. To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Adverse events)

    Percentage of patients with at least one adverse event. Toxicity profile will be assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0. Patients with each adverse event will be calculated over the total number of patients exposed in each treatment arm.

    Measured: 25 months

  10. Time to initiate opioid use (≥ 7 days)

    Time to initiate opioid use (≥ 7 days) is defined as the time from randomization to the first initiation of opioid analgesic use lasting for 7 or more consecutive days, regardless of the reason, or until death, whichever occurs first in each treatment arm.

    Measured: 48 months

  11. To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Serious adverse events).

    Patients with at least a serious adverse event will be calculated over the total number of patients exposed in each treatment arm.

    Measured: 25 months

  12. To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Adverse events leading to treatment discontinuation ).

    Patients with at least an adverse event leading to treatment discontinuation and adverse events leading to death will be calculated over the total number of patients exposed in each treatment arm.

    Measured: 25 months

  13. To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Death)

    Dead patients calculated over the total number of patients exposed in each treatment arm.

    Measured: 25 months

  14. To assess the quality of life of patients with FACT-P subscale

    Change from baseline over time in FACT-P subscale in each treatment arm.

    Measured: 24 months

  15. To assess the quality of life of patients with BPI-SF interference subscale

    Change from baseline over time in BPI-SF interference subscale in each treatment arm.

    Measured: 24 months

  16. To assess the quality of life of patients with BPI-SF interference subscale.

    Change from baseline over time in BFI subscale in each treatment arm.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start5 Jun 2026
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

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
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07333066
Sponsor's protocol ID
REINFORCE
Other IDs
2025-524408-30-00, 2025
Acronym
REINFORCE
Status last verified
Jun 2026
First submitted
30 Dec 2025
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apalutamide (Erleada™) 60 mg or 240 mg tablets and Docetaxel in people with Metastatic Hormone-sensitive Prostate Cancer, run by Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD at 56 sites in 5 countries.

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 21 inclusion and 24 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Spain, France, Germany, Italy, Portugal. 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?

Contact GUARD (+34 93 452 79 18, info@guardconsortium.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free Survival (EFS) (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07333066.

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 17 Jun 2026.

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