Study Comparing Radium-223 Dichloride with Abiraterone Acetate, Enzalutamide, and Prednisone in Patients with Advanced Prostate Cancer Spread to the Bone

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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-resistant prostate cancer (mCRPC). This is a form of prostate cancer that has spread to other parts of the body, particularly the bones, and continues to grow even when the amount of testosterone in the body is reduced to very low levels. The study is comparing two treatments: Radium-223 dichloride (Xofigo), which is a treatment that emits radiation to help kill cancer cells, and a new type of treatment that inactivates hormones, known as novel anti-hormonal therapy (NAH). The purpose of the study is to assess the overall survival of patients receiving Radium-223 dichloride compared to those receiving a second line of NAH.

Participants in the study will receive either Radium-223 dichloride or one of the NAH treatments, which may include medications such as abiraterone acetate (Zytiga), enzalutamide (Xtandi), prednisone, or prednisolone. These medications are taken orally, except for Radium-223 dichloride, which is given as an injection. The study will monitor the participants over a period to observe the effects of the treatments on their cancer and overall health. The study will also look at other factors such as the time it takes for symptoms to worsen, any side effects experienced, and the impact on the participants’ quality of life.

This trial aims to provide valuable information on the effectiveness and safety of Radium-223 dichloride compared to NAH in treating patients with mCRPC. By participating in this study, researchers hope to better understand which treatment option may offer the best outcomes for patients with this type of prostate cancer.

1 randomization

Upon joining the study, participants are randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment being studied.

2 treatment with radium-223 dichloride

Participants in this group receive radium-223 dichloride, which is administered as an intravenous injection. This treatment is given once every four weeks for a total of six injections.

Radium-223 dichloride is a radioactive substance that targets cancer cells in the bones.

3 treatment with novel anti-hormonal therapy (NAH)

Participants in this group receive a standard dose of a novel anti-hormonal therapy. This may include medications such as abiraterone acetate or enzalutamide, which are taken orally.

Abiraterone acetate is taken as 500 mg film-coated tablets, while enzalutamide is taken as 40 mg soft capsules. The specific dosage and frequency depend on the medication prescribed by the study team.

4 concomitant medication

Participants may also receive prednisone or prednisolone as part of their treatment regimen. These are oral medications taken as 5 mg tablets to help manage side effects and support the main treatment.

5 monitoring and assessments

Throughout the study, participants undergo regular monitoring and assessments to evaluate their health and the effectiveness of the treatment. This includes blood tests, imaging studies, and questionnaires about symptoms and quality of life.

The primary goal is to assess overall survival, while secondary goals include monitoring for skeletal events, progression of the disease, and any side effects experienced.

6 end of treatment

The treatment phase concludes after the completion of the prescribed regimen. Participants continue to be monitored for any long-term effects and overall health outcomes.

Who Can Join the Study?

  • Participant must be at least 18 years old at the time of signing the informed consent.
  • Must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, which means the participant is fully active or has some symptoms but can still carry out light work.
  • Must have a life expectancy of at least 6 months.
  • Must be able to swallow certain medications as whole tablets or capsules.
  • Must meet specific laboratory test requirements, such as having a certain level of blood cells, liver function, and kidney function.
  • Must be male and agree to use contraception if they have a partner who can become pregnant.
  • Must be able to give signed informed consent, agreeing to follow the study’s requirements.
  • Must have a confirmed diagnosis of prostate cancer.
  • Must have prostate cancer that has progressed after treatment with certain approved medications for at least 3 months.
  • Must have had at least two cycles of a specific type of chemotherapy for prostate cancer or be unable or unwilling to have such treatment.
  • Must have evidence of prostate cancer progression based on specific criteria.
  • Must have at least two bone metastases, which are cancer spots in the bones, and no history of cancer spread to the lungs, liver, or brain.
  • Must have symptoms of prostate cancer, such as pain, assessed during the screening period.
  • Must maintain low testosterone levels through medical or surgical means.
  • Must be on treatment to protect bones unless it is not recommended by the doctor.

Who Cannot Join the Study?

  • Patients who do not have metastatic castrate resistant prostate cancer (mCRPC). This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Patients who are not male. This study is only for male participants.
  • Patients who are not within the specified age range. The study is for certain age groups, so if you are outside this range, you cannot participate.
  • Patients who belong to a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centre Antoine Lacassagne Nice France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Puerta Del Mar Cadiz Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Fakultni Nemocnice Bulovka Prague Czechia
Urocentrum Praha s.r.o. Prague Czechia
Hospital Universitario De Jaen Jaen Spain
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Oulu University Hospital Oulu Finland
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Onko-Centrum Sp. z o.o. Lublin Poland
Ente Ospedaliero Ospedali Galliera Di Genova Genoa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Kepler Universitaetsklinikum GmbH Linz Austria
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Hospital Universitario Lucus Augusti Lugo Spain
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Pirkanmaan hyvinvointialue Tampere Finland
Hopital Beaujon Clichy France
Universita’ Degli Studi Di Ferrara Ferrara Italy
Servei De Salut De Les Illes Balears Palma Spain
Krajska zdravotni a.s. Teplice Czechia
Vilnius University Hospital Vilnius Lithuania
Fakultni Thomayerova nemocnice Prague Czechia
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Centro Oncologico De Galicia A Coruna Galicia Spain
Krajska nemocnice Liberec a.s. Liberec Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Aflevbx Oihuodijtyy Urzsrermxwsqs Pwipx Parma Italy
Cefuyj Hopmurvpgjx Ufstbwqcekyfw Rsxyh Reims France
Ezbqmannwpvrwxloa hvqubmwlxwebqrk Seinajoki Finland
Ujlbjllgczespenmwjgie Mstwyzab Awm Munster Germany
Acsxbbz Ogdnewftmqx Nqfdisrsl Sj Atewqrt E Bifjyb E C Axoszg Auutgqdvyto Alexandria Italy
Nfalmyof Izddpvpr Oyvskjeiv Ive Mllui Sjrrwubpqblqtfuqtwqgkacegyob Igkjdqnl Bvcdrzxj Cracow Poland
Hrhxzwxq Du Lz Sbeth Chod I Splb Pmw Barcelona Spain
Imwtilxu Ckmcfj Dgiezqwhzoimyqrug L'hospitalet De Llobregat Spain
Hoigpdte Uthwigqkbpowa Hjuzjjuh Tdcoj y Pyzhct Iotgsjto Copudc dsaubochgjnpotbmz (htsx Badalona Spain
Hxadhqtp Vryh daetbafl Barcelona Spain
Iynhkidf Pnyrgzytbsplnci Cpxtdp Cjoatm Marseille 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
09.11.2020
Czechia Czechia
Not recruiting
09.11.2020
Finland Finland
Not recruiting
09.11.2020
France France
Not recruiting
09.11.2020
Germany Germany
Not recruiting
09.11.2020
Hungary Hungary
Not recruiting
09.11.2020
Italy Italy
Not recruiting
09.11.2020
Lithuania Lithuania
Not recruiting
09.11.2020
Poland Poland
Not recruiting
09.11.2020
Spain Spain
Not recruiting
09.11.2020

Trial locations

Radium-223 Dichloride is a type of radiation therapy used to treat prostate cancer that has spread to the bones. It works by delivering targeted radiation to the cancer cells in the bones, helping to slow down the growth of the cancer and reduce symptoms such as pain.

Novel Anti-Hormonal Therapy (NAH) refers to a group of medications that block the effects of male hormones, which can help slow the growth of prostate cancer. These therapies are used when the cancer continues to grow despite other treatments that lower hormone levels.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by cancer cells that have become resistant to hormonal therapy, which is typically used to control prostate cancer growth. The disease often spreads to bones and can lead to symptoms such as bone pain and fractures. As the cancer progresses, it may cause urinary problems, fatigue, and weight loss. The progression of the disease is monitored through various clinical endpoints, including overall survival and time to symptomatic skeletal events.

Trial ID:
2023-505830-89-00
Protocol code:
20510
NCT ID:
NCT04597125
Trial Phase:
Therapeutic confirmatory (Phase III)

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