Study on Capivasertib and Docetaxel for Treating Metastatic Castration-Resistant Prostate Cancer in Patients

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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 continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is testing a new treatment combination of two drugs: Capivasertib and Docetaxel. Capivasertib, also known by its code name AZD5363, is taken as a film-coated tablet, while Docetaxel is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to compare the effectiveness and safety of the combination of Capivasertib and Docetaxel against a combination of a placebo and Docetaxel in treating patients with mCRPC. A placebo is a substance with no active drug, used to compare the effects of the actual drug. Participants in the study will be randomly assigned to receive either the Capivasertib and Docetaxel combination or the placebo and Docetaxel combination. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual drug combination or the placebo combination.

Throughout the study, participants will receive regular treatments and will be monitored closely by the research team. The main goal is to assess the overall survival of patients, which refers to the length of time from the start of the study until death from any cause. The study will also look at other factors such as the progression of the cancer, changes in pain levels, and any side effects experienced by the participants. The study is expected to continue until December 2026, with the aim of providing valuable information on the potential benefits of Capivasertib in combination with Docetaxel for treating mCRPC.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving capivasertib and docetaxel, and the other receiving a placebo and docetaxel.

The study is designed to assess the effectiveness and safety of these treatments for metastatic castration-resistant prostate cancer.

2 treatment initiation

The patient will begin treatment with docetaxel, administered as an intravenous infusion. This will occur every three weeks.

In addition, the patient will take capivasertib or a placebo orally, in the form of film-coated tablets, twice daily for four days each week.

3 treatment continuation

The treatment with docetaxel and either capivasertib or placebo will continue for the duration of the study, unless the patient experiences unacceptable side effects or the disease progresses.

Regular assessments will be conducted to monitor the patient’s health and response to the treatment.

4 monitoring and assessments

Throughout the study, the patient will undergo various assessments to evaluate the effectiveness of the treatment. These may include imaging tests, blood tests, and evaluations of pain and physical functioning.

The primary goal is to measure overall survival, while secondary goals include monitoring disease progression and quality of life.

5 completion of the study

The study is expected to conclude by December 2026. At this point, the final data will be collected and analyzed to determine the outcomes of the treatment.

The patient will receive information about the results and any further steps, if applicable.

Who Can Join the Study?

  • Must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of prostate cancer, without having a major presence of other types like neuroendocrine or small cell cancers.
  • Must be able and willing to swallow and keep oral medication.
  • Must agree to either not engage in heterosexual intercourse or use birth control methods, and also agree not to donate sperm.
  • Must have evidence of cancer that has spread to other parts of the body, shown by at least one bone lesion (a spot on the bone that shows up on a scan) or at least one soft tissue lesion (a growth that can be measured or not measured).
  • Must have been treated with a newer type of hormonal therapy for prostate cancer, such as abiraterone, enzalutamide, apalutamide, or darolutamide, for at least 3 months and shown signs of the disease getting worse during this treatment.
  • Must show evidence of metastatic castration-resistant prostate cancer (mCRPC), which means the cancer is still progressing despite treatments that lower testosterone.
  • Must have a serum testosterone level of 50 ng/dL or lower.
  • Must be a suitable candidate for treatment with docetaxel, a type of chemotherapy, and steroid therapy.
  • Must be continuing androgen deprivation therapy (ADT), which is a treatment to lower male hormones, using either LHRH agonist, LHRH antagonist, or having had both testicles removed (bilateral orchiectomy).
  • Must have a performance status of 0 to 1 according to the Eastern Cooperative Oncology Group (ECOG) or World Health Organisation (WHO), which means being fully active or having some symptoms but still able to carry out light work, and must have a life expectancy of at least 12 weeks.
  • Must have a sample of the tumor tissue that was preserved in a specific way (formalin-fixed paraffin embedded) available to send to a central laboratory for testing.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Metastatic Castration Resistant Prostate Cancer (mCRPC). This is a specific 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 female, as the study is only for male participants.
  • Patients who are part of a vulnerable population, which means they 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
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Centre Jean Perrin Clermont Ferrand France
Metropolitan General Hospital Cholargos Greece
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Centre Hospitalier Universitaire Rouen Rouen France
Orszagos Onkologiai Intezet Budapest Hungary
Centre hospitalier universitaire de Liege Liege Belgium
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital Del Mar Barcelona Spain
Az Maria Middelares Gent Gent Belgium
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Hospital Quironsalud Sagrado Corazon Sevilla Spain
Mazowiecki Szpital Onkologiczny Sp. z o.o. Wieliszew Poland
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
General University Hospital Of Patras Patras Greece
Hospital Universitario Lucus Augusti Lugo Spain
Unite De Recherche Clinique HIA Begin Saint-Mande France
Hopital Beaujon Clichy France
Saint Savvas Oncology Hospital Athens Greece
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Immobiliere De Nancy Nancy France
Spaarne Gasthuis Hoofddorp The Netherlands
Fakultni Thomayerova nemocnice Prague Czechia
University Of Szeged Szeged Hungary
Institut de Cancérologie de l’Ouest Saint-Herblain France
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Hospital Universitario Virgen De La Victoria Malaga Spain
Metropolitan Hospital Athens Greece
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Wosqrlrqqer Wpkcijzidkupwhrxxrah Cxjonmc Ouwcxxugq I Tnsyzcspnlfde Im Mctkagxbbxz W Lrnyi Lodz Poland
Iuqdnjav Mvovqospwj Mbmrxhxeux Paris France
Hnakvj Htprowngj Hmdrab Dobythompz &vqzi Twrkzmmtdtz Cmqpkj ov Anllkt Athens Greece
Mgykvzqgo shhapq Horovice Czechia
Pvvo Tnwhf Hsessycg Uessuiaizsmm Sabadell Spain
Bwunzmpqbti Vedfwrmpk Oxiocueahyea Kecskemet Hungary
Cgpxxo di Rostnnbhtlifl &pfmjfb Cyiiufgt Srrkfi Aqes STRASBOURG, Alsace France
Fttkmwxa nrzxqcgql Motde a Hkawqhb Prague Czechia
Ahdhyuxozw Phrpgyjo Huvfqlcn Dx Mpizflnqk Marseille France
Nzrfqyib Ivxosjhz Ozhfnwrpe Iqf Mderx Seccaaahsuknlbdlxjnlomkzkpdd Igdvyjie Bmetujrl Cracow Poland
Hmqnfmev Dl Le Snciz Cxfz I Simk Paq Barcelona Spain
Hkcmahg Hxddd Mkkzrs &lzbari 1 rfo Gdiiklk Exsobj Creteil France
Hnflzely Vjyc daqqafgz Barcelona Spain
Uybfucuvbz Gqtqqen Hyncyiam Aiestqu Athens Greece

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
18.03.2022
Czechia Czechia
Not recruiting
18.03.2022
France France
Not recruiting
18.03.2022
Greece Greece
Not recruiting
18.03.2022
Hungary Hungary
Not recruiting
18.03.2022
Poland Poland
Not recruiting
18.03.2022
Spain Spain
Not recruiting
18.03.2022
The Netherlands The Netherlands
Not recruiting
18.03.2022

Trial locations

Investigated drugs:

Capivasertib is a medication being studied for its potential to treat metastatic castration-resistant prostate cancer. It is being tested in combination with another drug to see if it can improve survival rates in patients with this type of cancer.

Docetaxel is a chemotherapy drug commonly used to treat various types of cancer, including prostate cancer. In this study, it is used in combination with capivasertib to evaluate if the combination is more effective than using docetaxel alone.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to progress despite treatments that lower testosterone levels. It has spread to other parts of the body, such as bones or lymph nodes, making it metastatic. The cancer cells in this condition are resistant to hormonal therapy, which is typically used to control prostate cancer. As the disease progresses, patients may experience symptoms such as bone pain, urinary issues, and fatigue. The progression of the disease can lead to further complications, including skeletal-related events and increased pain. The focus of treatment is often on managing symptoms and slowing the progression of the disease.

Trial ID:
2023-504996-26-00
Protocol code:
D361EC00001
NCT ID:
NCT05348577
Trial Phase:
Therapeutic confirmatory (Phase III)

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