Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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.

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. (NCT07333066) is a Phase 3 interventional studying Metastatic Hormone-sensitive Prostate Cancer, sponsored by Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Metastatic Hormone-sensitive Prostate Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 320 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Written willing to sign a consent form. Each patient must sign an willing to sign a consent form 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. diagnosed by tissue sample (biopsy-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. blood count (hemoglobin) at least 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Apalutamide (Erleada™) 60 mg or 240 mg tablets

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.

DRUG

Docetaxel

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

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

CH Bayonne
Bayonne, France
Institut Bergonié
Bordeaux, France
CHP Brest - Pasteur
Brest, France
Hôpital Henri-Mondor
Créteil, France
GHM Cancérologie - Institut Daniel Hollard
Grenoble, France
Hôpital Franco-Britannique
Levallois-Perret, France
GHBS - Hôpital du Scorff
Lorient, France
Centre De Cancérologie Du Grand Montpellier
Montpellier, France
Institut du Cancer de Montpellier - Val d'Aurelle (ICM)
Montpellier, France
CHU Nîmes
Nîmes, France
Hospices Civils de Lyon - HCL
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Paris Saint-Joseph
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
CHU Poitiers
Poitiers, France
Institut Godinot
Reims, France
CHU de Rennes
Rennes, France
Polyclinique Saint Georges
Saint-Georges-de-Didonne, France
CHP Saint Gregoire
Saint-Grégoire, France
Hôpital Foch
Suresnes, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07333066), the sponsor (Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07333066 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07333066?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07333066?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07333066. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07333066. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.