New hope for tough prostate cancers: adding chemo to targeted therapy

NCT ID NCT07333066

Disease control Sponsor: Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether adding the chemotherapy drug docetaxel to the standard treatment (apalutamide plus hormone therapy) can help men with metastatic hormone-sensitive prostate cancer who did not have a strong initial response to apalutamide alone. About 320 men will be randomly assigned to receive either the standard treatment or the intensified combo. The goal is to see if the combo delays cancer progression or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: docetaxel and apalutamide
What this could lead to: If successful, this could offer a more effective treatment strategy for men with metastatic prostate cancer who do not respond well to initial therapy, potentially delaying disease progression.
What could go wrong: This is an early-stage Phase 3 trial with 320 participants, so results may not apply to all patients. Adding chemotherapy (docetaxel) increases side effects like fatigue, infection risk, and nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Patient must be a man ≥18 years of age. 3. Histologically or cytologically confirmed adenocarcinoma of prostate. 4. Metastatic hormone-sensitive prostate cancer. 5. PSA \>5 ng/ml at diagnosis of metastatic disease. 6. Patients eligible to continue treatment with apalutamide and ADT and without contra-indication to receive docetaxel. 7. Patients with at least 24 weeks and no more than 30 weeks of apalutamide. 8. Patients with a maximum of 12 weeks ADT before apalutamide initiation. 9. 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. 10. Patients who have not progressed to apalutamide. 11. Patients that are tolerating adequately apalutamide 240 mg daily and with no toxicity higher than G1 at inclusion. 12. Be able to swallow whole apalutamide film-coated tablets. 13. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 14. Clinical laboratory values at screening: 1. hemoglobin ≥10.0 g/dL, 2. absolute neutrophil count ≥1.5 × 10\*9/L, 3. 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 4. serum alanine aminotransferase and/or aspartate transaminase ≤1.5 × the upper limit of normal (ULN), 5. total bilirubin ≤ ULN, 6. creatinine ≤2.0 × ULN 15. 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. Exclusion Criteria: 1. Presence of neuroendocrine histology. 2. Apalutamide treatment started more than 30 weeks before inclusion. 3. Progression disease by any means, including radiographic, clinical or serological at inclusion. 4. Patient who achieves deep PSA response on apalutamide treatment before randomization. 5. Previous androgen-pathway receptor inhibitors, including enzalutamide, darolutamide, abiraterone or other ARPI. Previous treatment with first generation antiandrogens (i.e. bicalutamide) is allowed. 6. Chemotherapy or immunotherapy for prostate cancer before randomization. 7. Treatment with radiotherapy (external-beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization. 8. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs. 9. Contraindication to both computed tomography and magnetic resonance imaging contrast agent. 10. 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. 11. Any of the following within 6 months before randomization: 1. stroke, 2. myocardial infarction, 3. severe or unstable angina pectoris, 4. uncontrolled arrhythmia, 5. coronary or peripheral artery bypass graft, or 6. congestive heart failure (New York Heart Association class III or IV) 12. Peripheral neuropathy ≥ grade 2. 13. Uncontrolled hypertension, indicated by resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite medical management. 14. 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. 15. A gastrointestinal disorder or procedure that was expected to interfere significantly with absorption of study drug. 16. Active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment. 17. 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. 18. 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.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormone sensitive prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

56 sites in 5 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

ARNAS Garibaldi - Catania
NOT_YET_RECRUITING

Catania, Italy
CH Bayonne
NOT_YET_RECRUITING

Bayonne, France
CHP Brest - Pasteur
NOT_YET_RECRUITING

Brest, France
CHP Saint Gregoire
NOT_YET_RECRUITING

Saint-Grégoire, France
CHU Nîmes
NOT_YET_RECRUITING

Nîmes, France
CHU Poitiers
NOT_YET_RECRUITING

Poitiers, France
CHU de Rennes
NOT_YET_RECRUITING

Rennes, France
Centre De Cancérologie Du Grand Montpellier
NOT_YET_RECRUITING

Montpellier, France
Facharztzentrum für Urologie, Uro-Onkologie
NOT_YET_RECRUITING

Berlin, Germany
Fundación Instituto Valenciano de Oncología
NOT_YET_RECRUITING

Valencia, Valencia, Spain
GHBS - Hôpital du Scorff
NOT_YET_RECRUITING

Lorient, France
GHM Cancérologie - Institut Daniel Hollard
NOT_YET_RECRUITING

Grenoble, France
Hospices Civils de Lyon - HCL
NOT_YET_RECRUITING

Paris, France
Hospital Clinico Universitario de Valencia
NOT_YET_RECRUITING

Valencia, Valencia, Spain
Hospital Clínic de Barcelona
NOT_YET_RECRUITING

Barcelona, Barcelona, Spain
Hospital Clínico Universitario Santiago de Compostela
NOT_YET_RECRUITING

Santiago de Compostela, La Coruña, Spain
Hospital Clínico Universitario de Valladolid
NOT_YET_RECRUITING

Valladolid, Valladolid, Spain
Hospital General Universitario Morales Meseguer
NOT_YET_RECRUITING

Murcia, Murcia, Spain
Hospital General Universitario de Valencia
NOT_YET_RECRUITING

Valencia, Valencia, Spain
Hospital Riuniti di Foggia - Foggia
NOT_YET_RECRUITING

Foggia, Italy
Hospital Santa Creu i Sant Pau
NOT_YET_RECRUITING

Barcelona, Barcelona, Spain
Hospital Universitari Vall d´Hebron
NOT_YET_RECRUITING

Barcelona, Bacelona, Spain
Hospital Universitario 12 Octubre
RECRUITING

Madrid, Madrid, Spain
Hospital Universitario Clínico San Carlos
NOT_YET_RECRUITING

Madrid, Madrid, Spain
Hospital Universitario La Paz
NOT_YET_RECRUITING

Madrid, Madrid, Spain
Hospital Universitario Marques de Valdecilla
NOT_YET_RECRUITING

Santander, Cantabria, Spain
Hospital Universitario Miguel Servet
NOT_YET_RECRUITING

Zaragoza, Aragon, Spain
Hospital Universitario Ramón y Cajal
NOT_YET_RECRUITING

Madrid, Madrid, Spain
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING

Seville, Sevilla, Spain
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING

Málaga, Málaga, Spain
Hospital Universitario Virgen de las Nieves
NOT_YET_RECRUITING

Granada, Granada, Spain
Hospital del Mar
NOT_YET_RECRUITING

Barcelona, Barcelona, Spain
Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING

Paris, France
Hôpital Foch
NOT_YET_RECRUITING

Suresnes, France
Hôpital Franco-Britannique
NOT_YET_RECRUITING

Levallois-Perret, France
Hôpital Henri-Mondor
NOT_YET_RECRUITING

Créteil, France
Hôpital Paris Saint-Joseph
NOT_YET_RECRUITING

Paris, France
Hôpital Pitié-Salpêtrière
NOT_YET_RECRUITING

Paris, France
ICO Badalona
NOT_YET_RECRUITING

Barcelona, Barcelona, Spain
Institut Bergonié
NOT_YET_RECRUITING

Bordeaux, France
Institut Català d'Oncologia (ICO) L´Hospitalet de Llobregat
NOT_YET_RECRUITING

L'Hospitalet de Llobregat, Barcelona, Spain
Institut Godinot
NOT_YET_RECRUITING

Reims, France
Institut du Cancer de Montpellier - Val d'Aurelle (ICM)
NOT_YET_RECRUITING

Montpellier, France
Johanniter-Krankenhaus Bonn-Gronau
NOT_YET_RECRUITING

Bonn, Germany
Klinikum Recklinghausen
NOT_YET_RECRUITING

Recklinghausen, Germany
National Instute of Oncology - Milan
NOT_YET_RECRUITING

Milan, Italy
Policlinico Gemelli Hospital - Rome
NOT_YET_RECRUITING

Roma, Italy
Policlinico Umberto I - Rome
NOT_YET_RECRUITING

Roma, Italy
Polyclinique Saint Georges
NOT_YET_RECRUITING

Saint-Georges-de-Didonne, France
Praxis Berlin / FASANUS - Urologie - Andrologie - Uro-Onkologie
NOT_YET_RECRUITING

Berlin, Germany
SRH Wald-Klinikum Gera
NOT_YET_RECRUITING

Gera, Germany
ULS Alto Ave
NOT_YET_RECRUITING

Guimarães, Portugal
University Hospital Göttingen
NOT_YET_RECRUITING

Göttingen, Germany
University Hospital Rostock
NOT_YET_RECRUITING

Rostock, Germany
Urologicum Karlsruhe MVZ
NOT_YET_RECRUITING

Karlsruhe, Germany
Urologische Facharztpraxis Saale
NOT_YET_RECRUITING

Halle, Germany

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