Study on Apalutamide and Drug Combination for Patients with Metastatic Castration-Sensitive Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as Metastatic Castration-Sensitive Prostate Cancer (mCSPC). The study is investigating the effects of a treatment called Apalutamide, which is a medication taken as a film-coated tablet. The trial also involves the use of Androgen-Deprivation Therapy (ADT), which is a treatment that reduces male hormones to slow the growth of prostate cancer. The study aims to determine if using ADT intermittently, rather than continuously, can be just as effective in controlling the cancer while also reducing the side effects, such as hot flashes.

Participants in the study will receive treatment with Apalutamide and ADT for a period of time. The study will monitor the participants’ response to the treatment, particularly looking at how long they can go without the cancer progressing, as well as the severity of any hot flashes experienced. The study will use imaging techniques like MRI or CT scans to track the cancer’s progression. The goal is to see if the intermittent approach to ADT can maintain the same level of cancer control as continuous treatment, while potentially offering a better quality of life by reducing side effects.

In addition to Apalutamide and ADT, the study will also involve other treatments like Gonadotropin Releasing Hormone Analogues and Other Hormone Antagonists and Related Agents, which are used to manage hormone levels in the body. These treatments are administered through different methods, such as oral tablets or injections. The study will last for several years, with participants being closely monitored throughout the process to ensure their safety and to gather data on the effectiveness of the treatment strategies being tested.

1 initial treatment phase

Begin treatment with a combination of apalutamide and androgen-deprivation therapy (ADT).

Apalutamide is administered as a film-coated tablet taken orally.

The dosage and frequency of apalutamide will be determined by the study protocol.

ADT may involve the use of hormone antagonists and gonadotropin-releasing hormone analogues, administered either intravenously or subcutaneously.

This phase lasts for 6 months, during which the goal is to achieve a prostate-specific antigen (PSA) level of less than 0.2 ng/mL.

2 evaluation phase

After 6 months of treatment, an evaluation is conducted to assess the PSA response.

Participants who achieve the target PSA level will proceed to the next phase of the study.

3 randomization phase

Participants are randomly assigned to one of two groups: continued ADT with apalutamide or intermittent ADT with apalutamide.

The purpose is to compare the effectiveness of continuous versus intermittent therapy in maintaining disease control.

4 maintenance phase

Participants continue with their assigned treatment regimen.

Regular monitoring of PSA levels and other health indicators is conducted to track disease progression and treatment response.

This phase continues until the study’s end date or until specific criteria for discontinuation are met.

5 study completion

The study is estimated to conclude by August 23, 2027.

Final assessments are conducted to evaluate the long-term outcomes of the treatment strategies.

Who Can Join the Study?

Must be at least 18 years old or older, depending on the legal age of adulthood in the area where the study is conducted.
Must have been diagnosed with prostate cancer before the study begins, confirmed by examining tissue samples.
Must have prostate cancer that has spread to at least two different areas outside the prostate, as shown by imaging tests like CT, MRI, or bone scans.
Must not have any findings that suggest other types of prostate cancer, such as small cell, ductal, or neuroendocrine carcinoma.
Must have testosterone levels greater than 50 ng/dL at the start of the study, unless they have already received up to 3 months of hormone therapy before the study.
Can have another type of cancer, as long as it does not interfere with the study’s goals or treatment safety.
Must have a performance status score of 0 or 1, which means they are fully active or have some symptoms but do not need help with daily activities. If the score is 2 or 3, it must be due to stable physical limitations not related to prostate cancer.
If there are no liver metastases, liver function tests must be within certain limits: AST and ALT less than 3 times the upper limit of normal, and total bilirubin less than 1.5 times the upper limit of normal.
If there are liver metastases, liver function tests must be within certain limits: AST and ALT less than 5 times the upper limit of normal, and total bilirubin less than 3 times the upper limit of normal.
Must sign a consent form indicating understanding of the study and willingness to participate.
Must have certain blood counts: hemoglobin at least 9.0 g/dL, neutrophils at least 1.0 x 10³/μL, and platelets at least 50 x 10³/μL, without recent transfusions or growth factors.
If HIV-positive, must have no detectable viral load, a CD4+ count greater than 300 cells/mm³, no recent serious infections, and be on stable antiretroviral therapy.
Must agree to use condoms during sexual activity and ensure their partner uses effective contraception during the study and for 3 months after the last treatment dose.
Must agree not to donate sperm during the study and for 3 months after the last treatment dose. Consider sperm preservation before treatment, as cancer treatments may affect fertility.
Must agree not to plan to conceive a child during the study or within 3 months after the last treatment dose.
Must be willing and able to follow the lifestyle restrictions specified in the study protocol.
Must be able to swallow whole apalutamide tablets, either alone or with something like applesauce.

Who Cannot Join the Study?

Participants must not have any other serious medical conditions that could interfere with the study.
Participants should not have any other type of cancer that requires treatment.
Participants must not have had any major surgery within the last 4 weeks before joining the study.
Participants should not have any known allergies to the study medications.
Participants must not be taking any other experimental drugs.
Participants should not have any severe liver or kidney problems.
Participants must not have any uncontrolled heart conditions.
Participants should not have any active infections that require treatment.
Participants must not have any mental health conditions that could affect their ability to participate in the study.
Participants should not have any history of drug or alcohol abuse within the last 12 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Technische Universitaet Dresden	Dresden	Germany
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland

Other Sites

Site Name	City	Country
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR	Nuertingen	Germany
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.	Warsaw	Poland
Polimed Specjalistyczna Przychodnia Lekarska	Wroclaw	Poland
Uhbnqkiftr Htpavusj Cljiexk	Cologne	Germany
Uwyshjcbtsyinurcyaxtl Wlxzzkxjb Ade	Wuerzburg	Germany
Ctekpr Lmek Bedoji	Lyon	France
Uupltuevthuvqlajfzvxn Eiwfu Awg	Essen	Germany
Ulzijpgeezkhnuwpwqtgg Ayuvsuta	Augsburg	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.10.2023
Germany	Not recruiting	01.10.2023
Poland	Not recruiting	01.10.2023

Trial locations

Investigated drugs:

Apalutamide is a medication used in this trial to treat metastatic castration-sensitive prostate cancer. It works by blocking the effects of androgens, which are male hormones that can promote the growth of cancer cells. In this study, apalutamide is used in combination with androgen-deprivation therapy to help control the cancer.

Androgen-Deprivation Therapy (ADT) is a treatment that reduces the levels of male hormones in the body, which can help slow the growth of prostate cancer. In this trial, ADT is used continuously or intermittently to see if it can effectively manage the cancer while potentially reducing side effects like hot flashes.

Investigated diseases:

Prostate cancer

Metastatic Castration-Sensitive Prostate Cancer – This is a type of prostate cancer that has spread to other parts of the body but still responds to treatments that lower testosterone levels. The disease progresses as cancer cells grow and spread, often affecting bones and lymph nodes. Patients may experience symptoms such as bone pain, urinary issues, and fatigue. The cancer remains sensitive to hormone therapy, which can help control its growth. Over time, the disease may become resistant to hormone therapy, leading to further progression. Monitoring and managing symptoms are crucial as the disease advances.

Trial ID:

2022-502686-24-00

Protocol code:

56021927PCR3020

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Apalutamide and Drug Combination for Patients with Metastatic Castration-Sensitive Prostate Cancer

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