Study of Cabozantinib and Atezolizumab Compared to Hormonal Therapy in Adults with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This study focuses on patients with metastatic castration-resistant prostate cancer, a condition where prostate cancer has spread to other parts of the body and continues to grow despite treatments that lower testosterone levels. The study compares two different treatment approaches: a combination of cabozantinib and atezolizumab versus second-line hormonal therapy using either abiraterone or enzalutamide.

The purpose of the study is to evaluate how well the combination of cabozantinib and atezolizumab works compared to hormonal therapy in patients who have previously received one type of hormonal treatment and whose cancer has spread beyond the pelvis. Cabozantinib is a medication that blocks certain proteins involved in cancer growth, while atezolizumab is an immunotherapy drug that helps the immune system fight cancer cells.

During the study, participants will receive either the combination treatment or one of the hormonal therapies. All medications will be taken as prescribed by the study doctor. Patients receiving cabozantinib and atezolizumab will take cabozantinib by mouth and receive atezolizumab through intravenous infusion. Those assigned to hormonal therapy will take either abiraterone or enzalutamide tablets by mouth along with prednisone, a steroid medication.

1 Initial assessment

Your eligibility for the study will be confirmed through laboratory tests checking your blood cell counts, liver function, and kidney function.

A medical examination will verify that you have measurable cancer tissue outside the pelvic area.

Your testosterone levels must be below 50 ng/dL.

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Combination of cabozantinib (tablets) and atezolizumab (intravenous infusion)

Group 2: Either abiraterone tablets with prednisone tablets, or enzalutamide tablets

3 Treatment period

You will continue taking the assigned medication until your condition shows progression or you experience significant side effects.

Regular blood tests and imaging scans will monitor your response to treatment.

Your doctor will check for any side effects during scheduled visits.

4 Follow-up period

After completing treatment, you must use effective birth control methods for:

– 16 weeks after the last dose if you received cabozantinib and atezolizumab

– 3 weeks after the last dose if you received abiraterone

– 12 weeks after the last dose if you received enzalutamide

5 Study completion

The study is expected to continue until October 2026.

Your participation will end if your condition progresses or you experience unacceptable side effects.

Who Can Join the Study?

  • Must be male with confirmed prostate adenocarcinoma (a type of prostate cancer) through tissue or cell examination
  • Must be at least 18 years old
  • Must be able to understand and follow study requirements, including visits, treatments, and tests
  • Must have signed an informed consent form before screening
  • If sexually active, must use effective contraception during the study and for up to 4 months after treatment ends, including barrier methods like condoms
  • Must have either increasing PSA (prostate-specific antigen) levels or cancer growth while on previous hormone therapy
  • Must have had surgical removal of testicles or be on ongoing hormone therapy with testosterone levels ≤ 50 ng/dL at screening
  • Must have measurable cancer spread outside the pelvis, either in organs or lymph nodes above the lower belly
  • Must show disease progression through either rising PSA levels or visible growth of tumors
  • Must have an ECOG performance status (measure of daily living abilities) of 0 or 1
  • Must have recovered from side effects of previous treatments
  • Must have adequate organ function, including:
    • Sufficient blood cell counts
    • Normal liver function tests
    • Adequate kidney function
    • Negative tests for hepatitis B and C

Who Cannot Join the Study?

  • Previous treatment with more than one hormone therapy (such as abiraterone, apalutamide, darolutamide, or enzalutamide)
  • Female patients (study is designed only for male participants)
  • Age under 18 years
  • Known brain or spinal cord metastases (cancer spread to brain or spine)
  • Active autoimmune disease requiring systemic treatment
  • History of severe allergic reactions to biological treatments
  • Significant heart problems or uncontrolled high blood pressure
  • Active or chronic hepatitis B or C infection
  • HIV positive status
  • Other active cancers in the past 3 years (except for adequately treated non-melanoma skin cancer)
  • Major surgery within 4 weeks before starting the study
  • Current participation in other clinical trials
  • Inability to swallow oral medications
  • Any condition that would make participation unsafe or compromise study compliance

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centre Jean Perrin Clermont Ferrand France

Other Sites

Site Name City Country Status
Onkodok GmbH Guetersloh Germany
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Universitair Ziekenhuis Gent Gent Belgium
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Urocentrum Praha s.r.o. Prague Czechia
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Da Luz S.A. Lisbon Portugal
Champalimaud Clinical Centre Lisbon Portugal
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Ahiwdny Ozfsleyuqid Udxoqthvwgowq Pkycn Parma Italy
Agidgm Meqvgxz Crxtfn Sgyc Thessaloniki Greece
Hdhitdqz Dz Lz Smcqx Caiz I Siwb Pqc Barcelona Spain
Flewoblgg Pxye Lp Irjvjoroyzsjr Brscmvduq Dgm Hfpecwss Uvabwtgzkjily Ls Pbd Madrid Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
09.10.2020
Czechia Czechia
Not recruiting
09.10.2020
France France
Not recruiting
09.10.2020
Germany Germany
Not recruiting
09.10.2020
Greece Greece
Not recruiting
09.10.2020
Italy Italy
Not recruiting
09.10.2020
Poland Poland
Not recruiting
09.10.2020
Portugal Portugal
Not recruiting
09.10.2020
Spain Spain
Not recruiting
09.10.2020

Trial locations

Cabozantinib is a medication that targets specific proteins in cancer cells to help stop them from growing and spreading. It works by blocking signals that cancer cells use to grow and create new blood vessels.

Atezolizumab is an immunotherapy medication that helps the body’s immune system recognize and fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system.

Abiraterone is a hormone therapy medication used to treat prostate cancer. It works by stopping the body from producing testosterone, which can fuel prostate cancer growth.

Enzalutamide is also a hormone therapy medication for prostate cancer. It blocks testosterone from connecting with prostate cancer cells, which helps slow down or stop cancer growth.

Apalutamide is a hormone therapy medication that treats prostate cancer by preventing testosterone from helping cancer cells grow and spread.

Darolutamide is a hormone therapy medication used in prostate cancer treatment. It works by blocking the effects of testosterone on cancer cells.

Metastatic Castration-Resistant Prostate Cancer – A form of advanced prostate cancer that continues to grow despite treatments that lower testosterone levels in the body. In this condition, cancer cells have adapted to survive and multiply even when testosterone levels are very low. The cancer spreads (metastasizes) beyond the prostate to other parts of the body, commonly to bones, lymph nodes, or other organs. The disease typically develops progressively from earlier stages of prostate cancer, showing resistance to hormone therapy. The condition can affect multiple areas of the body simultaneously, with cancer cells forming new tumors in distant locations.

Trial ID:
2024-516481-11-00
Protocol code:
XL184-315
NCT ID:
NCT04446117
Trial Phase:
Therapeutic confirmatory (Phase III)

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