Study on Long-Term Safety of Enzalutamide, Abiraterone, and Prednisolone for Patients with Prostate Cancer from Previous Enzalutamide Trials

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What is this study about?

This clinical trial focuses on studying the long-term safety of a treatment for Prostate Cancer. The treatment being studied is a medication called Enzalutamide, which is taken as a soft capsule. This study is specifically for individuals who have previously participated in an enzalutamide clinical study and are continuing to benefit from the treatment. The purpose of the study is to gather information on the safety of enzalutamide over an extended period.

Participants in this study will continue to take enzalutamide as they did in their previous study. The study will monitor their health and any side effects they may experience while taking the medication. The study will last for a maximum of 36 months, during which participants will take enzalutamide daily. The study will also involve the use of other medications, such as Abiraterone and Prednisolone, which are also taken orally. These medications are used in combination with enzalutamide to manage prostate cancer.

Throughout the study, participants will be regularly assessed by healthcare professionals to ensure their safety and to determine the ongoing benefits of the treatment. The study aims to provide valuable information on the long-term use of enzalutamide and its effects on individuals with prostate cancer. Participants will be required to follow specific guidelines, such as using birth control methods, to ensure their safety and the integrity of the study results.

1 joining the study

Participation begins after providing written consent and agreeing to privacy terms as per national regulations.

Eligibility requires current treatment with enzalutamide for prostate cancer in a previous study sponsored by Astellas or Medivation/Pfizer, with continued benefit from the treatment as assessed by the investigator.

2 treatment continuation

Continue the treatment regimen from the prior study. Any changes to the treatment plan, such as dose adjustments or stopping a combination therapy, require approval from a medical monitor.

The ability to swallow enzalutamide capsules and comply with study requirements is necessary.

3 medication details

The study involves the oral administration of enzalutamide, abiraterone, and prednisolone.

The specific dosage and frequency of these medications will be determined by the investigator based on the previous study regimen.

4 safety and compliance

The main objective is to collect long-term safety data for those continuing to benefit from enzalutamide treatment.

Participants and their female partners of childbearing potential must use two forms of birth control during the study and for three months after the final administration of enzalutamide. One method must be highly effective, and the other must be a barrier method.

5 study duration

The estimated end date for the study is January 17, 2025.

Participants are required to avoid sperm donation during the study and for at least three months after the final administration of enzalutamide.

Who Can Join the Study?

  • The patient must provide a written agreement to participate in the study, which includes understanding privacy rules. This is called an Informed Consent.
  • The patient must currently be receiving a medication called enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation/Pfizer and must be benefiting from the treatment according to the doctor’s assessment.
  • The patient must be able to continue the treatment they were receiving in the previous study. If the doctor thinks a change is needed, such as adjusting the dose or stopping a combination therapy, approval from a medical monitor is required before joining the study.
  • The patient must be able to swallow enzalutamide capsules and follow the study requirements.
  • The patient and his female partner, if she can have children, must use two forms of birth control during the study and for three months after the last dose of enzalutamide. One form must be highly effective, like hormonal methods or an intrauterine device, and the other must be a barrier method, like a condom.
  • The patient must agree not to donate sperm during the study and for at least three months after the last dose of enzalutamide.

Who Cannot Join the Study?

  • Only male patients can participate in the study. Female patients are not eligible.
  • Patients who have not participated in a previous clinical study with the medication Enzalutamide are not eligible. Enzalutamide is a drug used in the treatment of prostate cancer.
  • Patients who did not benefit from the treatment in the previous study with Enzalutamide cannot participate. This means the treatment did not help them as expected.
  • Patients who were part of a study that has not yet completed its main analysis or evaluation period are not eligible. This means the previous study must have finished its main part.
  • Patients who are considered part of a vulnerable population are not eligible. A vulnerable population includes people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Urologikum Hamburg MVZ Hamburg Germany
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
University Hospital Maastricht Maastricht The Netherlands
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Region Vaesterbotten Umea Sweden
Vrije Universiteit Brussel Jette Belgium
Helse Stavanger HF Stavanger Norway
Az Maria Middelares Gent Gent Belgium
Spitalul Clinic Prof.Dr.Theodor Burghele Bucharest Romania
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
MD Anderson Cancer Center Madrid Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Universita’ Di Pisa Pisa Italy
Privatna Urologicka Ambulancia s.r.o. Trencin Slovakia
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universidade De Santiago De Compostela Santiago De Compostela Spain
Aalborg University Hospital Aalborg Denmark
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Medikard s.r.o. Presov Slovakia
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Fakultna Nemocnica S Poliklinikou Zilina Zilina Slovakia
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Pirkanmaan hyvinvointialue Tampere Finland
Uromedical Center s.r.o. Povel Czechia
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Androgeos spol. s r.o. Prague Czechia
Uroexam spol. s r.o. Nitra Slovakia
Ipdhwlfr Rhnadyyi Dl Cietji Dw Meiupbzqqiu Montpellier France
Vvvgcgtycwlghvvr hemixmblbjsjibj Turku Finland
Coabbul Uhvocpfviav Myslowice Poland
Zoyrvawgnh zvhppqdepdsfr Kshuok syylzl Kosice Slovakia
Cqrrqm spaxnp Rusovce Slovakia
Prwy Tespq Hdnvxgne Ucnyixnbuxuz Sabadell Spain
Camhyh dk Rvpgagzvieecr &xjawpd Caojdttn Svzvxr Ahsu STRASBOURG, Alsace France
Pohrs Hqppkidqi Psbwrsjyjuj Wroclaw Poland
Hunoiu Hnqgoikf Herlev Denmark
Ibngzlmh Rfkcleyos Pdl Lc Sugufn Dop Tqzsyb Dgru Aatiwip Igez Scinal Meldola Italy
Aqslkw Uzqirblaro Hrmoftcn Aarhus Denmark
Ucxpsvejbcuhtv Ccnzcrp Kzohfnaqv Gdansk Poland
Ijwcrsaf Cpddke Dctbsqunidcbricqv L'hospitalet De Llobregat Spain
Hozvktqy Vjva dwesualh Barcelona Spain
Hlnmgkam Uavxujaiafnetg Sxsusojtcb &falmnt Hmiyygz dc Hthnozimvbb STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
17.01.2017
Belgium Belgium
Not recruiting
17.01.2017
Czechia Czechia
Not recruiting
17.01.2017
Denmark Denmark
Not recruiting
17.01.2017
Finland Finland
Not recruiting
17.01.2017
France France
Not recruiting
17.01.2017
Germany Germany
Not recruiting
17.01.2017
Italy Italy
Not recruiting
17.01.2017
Norway Norway
Not recruiting
17.01.2017
Poland Poland
Recruiting
17.01.2017
Romania Romania
Not recruiting
17.01.2017
Slovakia Slovakia
Not recruiting
17.01.2017
Spain Spain
Not recruiting
17.01.2017
Sweden Sweden
Not recruiting
17.01.2017
The Netherlands The Netherlands
Not recruiting
17.01.2017

Trial locations

Enzalutamide is a medication used in this clinical trial for patients with prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. This study aims to gather long-term safety data for patients who have previously benefited from this treatment in earlier studies.

Investigated diseases:

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This type of cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulties with urination, blood in the urine, or pelvic discomfort. In some cases, prostate cancer can spread to other parts of the body, such as the bones or lymph nodes. The progression and symptoms can vary widely among individuals.

Trial ID:
2023-510298-33-00
Protocol code:
9785-CL-0123
NCT ID:
NCT02960022
Trial Phase:
Therapeutic exploratory (Phase II)

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