Study of Apalutamide for Patients with High-Risk Prostate Cancer After Prostate Removal

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What is this study about?

This clinical trial is focused on studying a treatment for patients with prostate cancer who are at high risk of the disease returning after having their prostate surgically removed. The treatment being tested is a medication called apalutamide, which is also known by its code name ARN-509. The medication is taken in the form of film-coated tablets. The purpose of the study is to determine if using apalutamide can help prevent the cancer from coming back compared to the usual care provided to patients.

Participants in the study will be randomly assigned to receive either apalutamide or the standard treatment. The study will monitor the participants over time to see if the cancer returns, spreads, or if there are any other significant health changes. The study aims to find out if apalutamide can help patients live longer without the cancer coming back.

Throughout the study, participants will take the medication orally and will be regularly checked by healthcare professionals to monitor their health and any effects of the treatment. The study is designed to provide valuable information on whether apalutamide can be an effective option for patients with high-risk prostate cancer after surgery.

1 joining the study

Upon joining the study, the patient must have signed an informed consent form. This indicates understanding and agreement to participate in the study.

The patient must be able to swallow the study medication tablets.

2 initial assessment

The patient must have a confirmed diagnosis of high-risk adenocarcinoma of the prostate after radical prostatectomy.

A series of imaging tests, such as CT-scan or MRI, must confirm the absence of metastatic disease. These tests should be conducted within 12 weeks before the radical prostatectomy.

3 eligibility confirmation

The patient must meet specific criteria, such as a Gleason score of 8 or higher, or other specified conditions, to be considered at high risk of disease recurrence.

The patient must have recovered from the radical prostatectomy within eight weeks and have a PSA level below 0.2 ng/ml before randomization.

4 randomization

The patient will be randomly assigned to receive either apalutamide or the standard of care treatment.

Apalutamide is administered as Erleada 60 mg film-coated tablets for oral use.

5 treatment phase

The patient will take the assigned treatment as directed. If receiving apalutamide, the dosage is 60 mg per day.

The treatment aims to prolong the time without biochemical recurrence of the disease.

6 monitoring and follow-up

The patient’s health and response to treatment will be regularly monitored throughout the study.

Progression-free survival, defined as the time from randomization until biochemical recurrence, metastases, or death, will be assessed.

7 study completion

The study is estimated to conclude by November 30, 2027.

Upon completion, the patient’s overall health and treatment outcomes will be evaluated.

Who Can Join the Study?

Must have signed an informed consent form, which means you agree to participate in the study after understanding all the details.
Must be able to swallow the study medication tablets.
If receiving apalutamide treatment, must agree to use a condom and another effective birth control method if having sex with a woman who can become pregnant, or use a condom if the woman is pregnant.
Must be a man who is 18 years of age or older.
Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer, after having surgery to remove the prostate (radical prostatectomy).
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest.
Must not have metastatic disease, which means the cancer has not spread to other parts of the body, confirmed by specific imaging tests like a CT scan or MRI.
Must meet certain criteria for high risk of cancer returning after surgery, based on specific test results like the Gleason score and PSA levels.
Must have recovered from the prostate surgery within eight weeks to participate in the study.
PSA, a protein produced by the prostate, must be below 0.2 ng/ml before starting the study.
Must have adequate blood, liver, and kidney function, which means certain blood test results must be within specific limits.

Who Cannot Join the Study?

Patients who are not male cannot participate in the study.
Patients who do not have a high risk of prostate cancer returning after surgery cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Klinikum Leverkusen gGmbH	Leverkusen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Urologicum Duisburg	Duisburg	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
Uikhrtfexewnhfiiautol Ewkdw Asx	Essen	Germany
Oenwvucjcnflkv Lekx Gdip	Linz	Austria
Uzstcoafogsteibiqzzdt Avnkbqyb	Augsburg	Germany
Uoskhtalunjdnwgtqlhlx Dgwpxmgozoh Aib	Duesseldorf	Germany
Ucxzgrbtgupuiubxtnacs Mmoaoutx Aan	Munster	Germany
Unbklpqkimt Pnagcmjdqmpsr Ksud Uoc	Cologne	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.12.2020
Germany	Not recruiting	01.12.2020

Trial locations

Investigated drugs:

Apalutamide

Apalutamide is a medication used in this trial to help prevent the return of prostate cancer in patients who are at high risk of the disease spreading after surgery. It works by blocking the action of male hormones that can promote the growth of cancer cells. The trial aims to see if using apalutamide after surgery can help patients live longer without signs of cancer returning.

Standard of Care (SOC) refers to the usual treatment given to patients with high-risk prostate cancer after surgery. This can include a variety of treatments that are commonly accepted and practiced by medical professionals to manage the condition. The trial compares the effectiveness of apalutamide against these standard treatments to see which approach is more beneficial for patients.

Investigated diseases:

Prostate cancer

Adenocarcinoma of the Prostate – Adenocarcinoma of the prostate is a type of cancer that begins in the gland cells of the prostate, which is a small gland in men that produces seminal fluid. This disease is characterized by the uncontrolled growth of cells in the prostate gland, which can eventually spread to other parts of the body. After a radical prostatectomy, which is a surgical procedure to remove the prostate gland, patients may still be at high risk for the cancer to return or spread. The progression of this disease can be monitored through biochemical markers, and it may lead to the development of metastatic disease if not managed effectively.

Trial ID:

2024-511832-29-00

Protocol code:

UKM17_0018

NCT ID:

NCT04295447

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Apalutamide for Patients with High-Risk Prostate Cancer After Prostate Removal

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