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Docetaxel and Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Have a Deep PSA Response After Initial Apalutamide Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is being done in metastatic hormone-sensitive prostate cancer, a type of prostate cancer that has spread to other parts of the body and still responds to hormone treatment. The study uses apalutamide (Erleada) taken by mouth and docetaxel given into a vein, along with ongoing hormone treatment. The purpose of the study is to see whether adding docetaxel to apalutamide can improve treatment results in people whose prostate cancer did not have a strong drop in PSA (prostate-specific antigen, a protein made by prostate cancer cells) after the first treatment.

After the first treatment with apalutamide and hormone therapy, the study compares continued treatment with apalutamide plus docetaxel and hormone therapy. Treatment is given over time, with regular study visits and follow-up checks. During the study, doctors watch for changes in the cancer, possible side effects, and how long the treatment continues to work. The study is Phase III, which means it is a late-stage trial designed to better understand how well this treatment approach works and how safe it is.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of study treatment
After joining the study, you receive apalutamide by mouth as erleada film-coated tablets. The dose is 240 mg once daily.
You also continue androgen deprivation therapy (adt). This is treatment that lowers male hormones, such as testosterone, which can help slow the cancer.
The study is for men with metastatic hormone-sensitive prostate cancer. This means the prostate cancer has spread to other parts of the body and is still responsive to hormone-lowering treatment.
Step 2
Response check after initial treatment
Your prostate-specific antigen (psa) is checked after the initial treatment with adt and apalutamide.
A deep psa response means the psa level falls to 0.2 ng/ml or lower, or a psa reduction of 90% or more together with a psa level of 4 ng/ml or lower.
If your psa response is not deep, meaning the psa is above 0.2 ng/ml with a psa reduction of less than 90%, or the psa reduction is 90% or more with a psa level above 4 ng/ml, the treatment is intensified.
Step 3
Treatment intensification
If you do not achieve a deep psa response, you receive docetaxel in addition to apalutamide and adt.
Docetaxel is given by vein as an intravenous infusion. The dose is 75 mg per square meter of body surface area.
The study description does not specify the exact number of doses or the total duration of docetaxel treatment.
Step 4
Follow-up during the study
Your condition is followed over time to assess whether the cancer worsens, whether further treatment is needed, and whether any bone-related symptoms occur.
The study also measures survival, psa changes, side effects, and changes in daily functioning and symptoms over time.
The total study period is planned from 15 march 2026 to 30 march 2030.

Who can join the trial?

26 criteria

Written informed consent: the patient must sign a consent form showing that he understands the study and agrees to take part.
The patient must be a man and be at least 18 years old.
The cancer must be confirmed by a tissue test, either histology or cytology: a tissue or cell test that shows the type of cancer present.
The patient must have metastatic hormone-sensitive prostate cancer, meaning the cancer has spread and is still responding to hormone treatment.
The PSA level at the time metastatic disease was diagnosed must be greater than 5 ng/ml. PSA stands for prostate-specific antigen, a protein measured in the blood.
The patient must still be able to continue apalutamide and ADT. ADT means androgen deprivation therapy, a treatment that lowers male hormones that can help prostate cancer grow.
The patient must have no reason not to receive docetaxel, a chemotherapy medicine.
The patient must have taken apalutamide for at least 24 weeks and no more than 30 weeks.
The patient must have had ADT for no more than 12 weeks before starting apalutamide.
After 24 to 30 weeks of apalutamide, the patient must have not reached a deep PSA response. A deep PSA response means the PSA is 0.2 ng/ml or lower, or the PSA has dropped by 90% or more and is also 4 ng/ml or lower.
The patient must have not had disease progression on apalutamide, meaning the cancer has not clearly gotten worse while taking it.
The patient must be tolerating apalutamide 240 mg daily, meaning he can take it without major problems.
The patient must have no side effects worse than grade 1 at study entry. Grade 1 means a mild side effect.
The patient must be able to swallow whole apalutamide tablets.
The patient must have an ECOG performance status of 1 or lower. ECOG is a scale of how well a person can do daily activities; a score of 1 means only slight limitation, and 0 means fully active.
check
Blood test results at screening must meet all of these limits:
- Hemoglobin must be at least 10.0 g/dL. Hemoglobin is the part of blood that carries oxygen.
- Absolute neutrophil count must be at least 1.5 × 10⁹/L. Neutrophils are white blood cells that help fight infection.
- Platelet count must be at least 100 × 10⁹/L. Platelets help blood clot.
- The patient must not have received a growth factor within the last 4 weeks. A growth factor is a medicine that helps blood cells grow.
- The patient must not have had a blood transfusion within the last 7 days. A transfusion means receiving donated blood.
- Alanine aminotransferase and/or aspartate transaminase must be at most 1.5 times the upper limit of normal. These are liver enzymes, which are substances in the blood that can rise when the liver is stressed or damaged.
- Total bilirubin must be at or below the upper limit of normal. Bilirubin is a substance made when the body breaks down red blood cells.
- Creatinine must be at most 2.0 times the upper limit of normal. Creatinine is a blood test that helps show how well the kidneys are working.
- Sexually active men must agree to use an external condom as a barrier method, meaning a condom worn on the penis.
- Sexually active men must agree not to donate sperm during the study treatment.
- If their female partner can become pregnant, the partner must use a highly effective birth control method during treatment and for 3 months after apalutamide and for 6 months after docetaxel.

Who cannot join the trial?

18 criteria

Neuroendocrine histology, meaning the prostate cancer has a special cell type called neuroendocrine cells.
Use of apalutamide for more than 30 weeks before joining the study.
Any sign that the cancer is getting worse at the time of joining, including on scans, by symptoms, or by blood tests.
Having a deep PSA response before randomization, meaning the prostate-specific antigen, a blood marker used to follow prostate cancer, has fallen to the required low level.
Previous treatment with other androgen receptor pathway inhibitors such as enzalutamide, darolutamide, abiraterone, or similar medicines. Older medicines like bicalutamide are allowed.
Previous chemotherapy or immunotherapy for prostate cancer before randomization. Chemotherapy is cancer treatment with drugs, and immunotherapy is treatment that helps the immune system fight cancer.
Radiation treatment within 2 weeks before randomization, including external-beam radiation, brachytherapy, or radiopharmaceuticals. Radiation treatment uses high-energy rays or radioactive medicines to treat cancer.
Known allergy or sensitivity to any study drug, to a drug in the same class, or to any ingredient in the study medicine.
Cannot receive contrast for both CT and MRI scans. Contrast is a dye used to make images clearer on scans.
A QTcF interval of 480 ms or more on the screening heart test, or having congenital long QT syndrome. QTcF is a measure of the heart’s electrical timing, and long QT syndrome is a heart rhythm problem present from birth.
Any of the following within the last 6 months: stroke, heart attack, severe or unstable chest pain called angina, uncontrolled abnormal heart rhythm, bypass surgery for the heart or leg arteries, or severe heart failure that causes symptoms with little activity or even at rest.
Peripheral neuropathy of grade 2 or higher. This means nerve damage, usually causing numbness, tingling, pain, or weakness, that is moderate or worse.
High blood pressure that is not controlled, with resting top number at least 160 mmHg or bottom number at least 100 mmHg despite treatment.
A previous cancer, except for certain skin cancers that were treated well, some early bladder cancers that did not spread deeply, or any cancer that was fully treated at least 5 years ago and has not come back.
A stomach or bowel problem, or a previous procedure, that would likely stop the study drug from being absorbed properly.
Active viral hepatitis, known HIV infection with detectable virus in the blood, or chronic liver disease that needs treatment.
Recent or current participation in another clinical study with an investigational medicine, meaning a medicine still being tested, within the required time before starting this study.
Any other serious or unstable medical, social, or psychological problem that could make the study unsafe, make it hard to follow the study rules, or affect the study results.

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Verified sites

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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
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Istituto Oncologico Veneto
Padua, Italy
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Universita Degli Studi Di Roma La Sapienza
Rome, Italy

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Investigated drugs

Apalutamide
is a hormone therapy taken by mouth. In this trial, it is used as part of the initial treatment and also continued in the treatment intensification plan. It works by blocking signals from male hormones that can help prostate cancer grow.
Docetaxel
is a chemotherapy medicine given into a vein. In this trial, it is added to treatment to make the cancer treatment stronger for patients whose PSA response was not deep enough after the first treatment. It helps kill cancer cells and may slow the disease down.

What is already known about the treatment

Apalutamide - Apalutamide is an oral film-coated tablet taken by mouth, and it is used in modern cancer treatment, especially for prostate cancer. It belongs to a group of medicines called androgen receptor blockers, which means it stops male hormones like testosterone from sending growth signals to prostate cancer cells. It is mainly used for metastatic hormone-sensitive prostate cancer and other advanced forms of prostate cancer, and it is well established in medical practice and medical literature as a standard treatment option.

Investigated diseases

Metastatic hormone-sensitive prostate cancer - A form of prostate cancer that has spread to other parts of the body but still responds to lowering male hormone levels. It usually starts in the prostate gland and then grows beyond it to places such as the bones or lymph nodes. The disease can progress over time from hormone-sensitive disease to a state where it no longer responds as well to hormone reduction.