Study on the Effectiveness of Apalutamide in Men with Castration-Resistant Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a condition known as Castration-Resistant Prostate Cancer, which is a type of prostate cancer that does not respond to treatments that lower testosterone. The study is testing a medication called Apalutamide, also known by its code name JNJ-56021927, to see if it can help men with this type of cancer. The trial will compare the effects of Apalutamide to a placebo, which is a substance with no active medication, to determine if Apalutamide can improve the time patients live without their cancer spreading, known as metastasis-free survival.

Participants in the study will receive either Apalutamide or a placebo, along with standard treatments such as Androgen Deprivation Therapy, which is a treatment that reduces male hormones in the body. Some participants may also receive other medications like ZYTIGA (abiraterone acetate) and PREDNISONE, which are used to manage prostate cancer. The study will last for a period of up to 48 months, during which participants will take the study medication orally in the form of film-coated tablets.

The purpose of this study is to evaluate the safety and effectiveness of Apalutamide in delaying the spread of prostate cancer in men who are at high risk of developing metastases. The trial aims to provide valuable information on whether Apalutamide can offer a better outcome for patients with castration-resistant prostate cancer compared to those who do not receive the active medication. Participants will be monitored regularly to assess their health and the progression of their cancer throughout the study period.

1 joining the study

Upon joining the study, participation is confirmed through a signed and dated informed consent document. This indicates understanding of all pertinent aspects of the trial.

2 randomization

Participants are randomly assigned to receive either the study drug Apalutamide or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

3 treatment administration

The study drug Apalutamide is administered orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol.

Participants may also receive ZYTIGA (abiraterone acetate) and PREDNISONE as part of the treatment regimen. ZYTIGA is available in 500 mg and 250 mg tablets, and PREDNISONE is administered orally.

4 monitoring and assessments

Regular visits are scheduled to monitor health status, treatment effects, and disease progression. This includes laboratory tests, radiographic assessments, and completion of patient-reported outcomes questionnaires.

5 follow-up

Long-term follow-up visits are conducted to assess the primary endpoint of Metastasis-Free Survival (MFS) and secondary endpoints such as time to metastasis, progression-free survival, and overall survival.

Who Can Join the Study?

Must have a confirmed diagnosis of prostate cancer that is resistant to castration, which means the cancer continues to grow even when testosterone levels are low.
Must be at high risk for the cancer spreading, shown by a PSA doubling time (PSADT) of 10 months or less. PSA is a protein made by the prostate, and its levels are used to monitor prostate cancer.
Must be 18 years of age or older.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means the patient is fully active or has some symptoms but does not need bed rest.
Must have testosterone levels below 50 ng/dL, achieved either through surgery or medication. If using medication, it must have been started at least 4 weeks before joining the study and continued throughout the study.
If receiving treatment to prevent bone loss, such as certain medications for osteoporosis, the patient must have been on a stable dose for at least 4 weeks before joining the study.
If previously treated with first-generation anti-androgens (medications that block male hormones), there must be a 4-week break before joining the study, and the cancer must still be progressing.
Must have stopped using certain medications, like 5-alpha reductase inhibitors or estrogens, and any other cancer treatments, at least 4 weeks before joining the study.
Must have recovered from any side effects of previous treatments or surgeries to a mild level or back to normal before joining the study.
Must have adequate organ function, which includes specific levels of liver enzymes, bilirubin, creatinine, neutrophils, platelets, and hemoglobin.
Must have signed a consent form indicating understanding of the trial details.
Must be willing and able to follow the study schedule, take the study medication, complete questionnaires, and attend follow-up visits.

Who Cannot Join the Study?

Patients who do not have Castration-Resistant Prostate Cancer cannot participate. This is a type of prostate cancer that continues to grow even when the amount of male hormones in the body is reduced to very low levels.
Only men can participate in this study. Women are not eligible.
Participants must be within a specific age range, typically adults and older adults.
Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Jean Perrin	Clermont Ferrand	France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Pellegrin Hospital	Bordeaux	France
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie	Poznan	Poland
Urocentrum Praha s.r.o.	Prague	Czechia
Spaarne Gasthuis	Hoofddorp	The Netherlands
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Aalborg University Hospital	Aalborg	Denmark
Policlinica De Diagnostic Rapid S.A.	Brasov	Romania
Sint Franciscus Vlietland Groep Stichting	Rotterdam	The Netherlands
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Rigshospitalet	Copenhagen	Denmark
Sgnhhyovrxv Sie z ompv	Kutno	Poland
Cxpwzn scldac	Rusovce	Slovakia
Pidl Tzlmc Hfpfpkes Unhjrcehmzge	Sabadell	Spain
Maoviac Ubgiixrnip Os Gehh	Graz	Austria
Ayistld Onfmujhnjpl Ujeqsocvguknl Cfgyurjhpwne Dseym Saccud E Djxdj Spsyula Dy Tejvhj	Turin	Italy
Uehfjusayqagtsvtpkfqu Mltflozw Adg	Munster	Germany
Hjkjsbip Vpvr dzyrilrd	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	11.11.2013
Belgium	Not recruiting	11.11.2013
Czechia	Not recruiting	11.11.2013
Denmark	Not recruiting	11.11.2013
France	Not recruiting	11.11.2013
Germany	Not recruiting	11.11.2013
Italy	Not recruiting	11.11.2013
Poland	Not recruiting	11.11.2013
Romania	Not recruiting	11.11.2013
Slovakia	Not recruiting	11.11.2013
Spain	Not recruiting	11.11.2013
The Netherlands	Not recruiting	11.11.2013

Trial locations

Investigated drugs:

Apalutamide is a medication used in the treatment of prostate cancer. It works by blocking the action of male hormones that can promote the growth of cancer cells. In this clinical trial, Apalutamide is being tested to see if it can help men with a specific type of prostate cancer, known as non-metastatic castration-resistant prostate cancer, live longer without the cancer spreading.

Investigated diseases:

Prostate cancer metastatic

Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow even when the amount of testosterone in the body is reduced to very low levels. It typically occurs after treatments that lower testosterone, such as surgery or medication, have been used. The disease is characterized by the cancer’s ability to progress despite the suppression of male hormones that usually fuel its growth. Over time, the cancer may spread to other parts of the body, such as bones or lymph nodes. Symptoms can include difficulty urinating, pain in the back or pelvis, and fatigue. The progression of the disease can vary, with some individuals experiencing a slow increase in symptoms, while others may notice more rapid changes.

Trial ID:

2023-509221-47-00

Protocol code:

ARN-509-003

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Apalutamide in Men with Castration-Resistant Prostate Cancer

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