Study of Capivasertib and Abiraterone for Patients with Metastatic Hormone-Sensitive Prostate Cancer with PTEN Deficiency

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as Metastatic Hormone-sensitive Prostate Cancer that is characterized by a deficiency in a gene called PTEN. The study is investigating the effectiveness and safety of a treatment combination involving two medications: Capivasertib and Abiraterone. Capivasertib is a medication taken as a film-coated tablet, and it is being tested alongside Abiraterone, which is already used in treating prostate cancer. Some participants will receive a placebo instead of Capivasertib to compare the outcomes.

The purpose of this study is to compare how well the combination of Capivasertib and Abiraterone works against the combination of a placebo and Abiraterone in patients with this specific type of prostate cancer. The study will monitor how long patients live without their cancer getting worse, which is known as radiographic progression-free survival. Participants will be randomly assigned to receive either the Capivasertib and Abiraterone combination or the placebo and Abiraterone combination. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed.

Throughout the study, participants will take the medication orally and will have regular check-ups to monitor their health and the progression of their cancer. The study aims to provide valuable information on the potential benefits of adding Capivasertib to the treatment regimen for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer. The trial is expected to continue until 2027, with recruitment starting in 2024.

1 joining the study

Upon joining the study, participation is confirmed for individuals with metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency.

Eligibility is determined by specific criteria, including a confirmed diagnosis and ongoing hormone therapy.

2 randomization

Participants are randomly assigned to one of two groups: one receiving capivasertib and abiraterone, and the other receiving a placebo and abiraterone.

This process ensures that the study results are unbiased and reliable.

3 medication administration

Participants take the assigned medication orally. Capivasertib and abiraterone are administered in the form of film-coated tablets.

The dosage and frequency of administration are determined by the study protocol and monitored by the study team.

4 monitoring and assessments

Regular assessments are conducted to monitor the effects of the treatment. This includes evaluating radiographic progression-free survival, overall survival, and other health indicators.

Participants may undergo imaging tests such as CT or MRI scans to assess the progression of the disease.

5 safety and tolerability evaluation

The safety and tolerability of the treatment are continuously evaluated. This involves monitoring for any side effects or adverse reactions to the medication.

Participants are encouraged to report any symptoms or concerns to the study team promptly.

6 completion of the study

The study is estimated to conclude by March 26, 2027. Participants will be informed about the end of their involvement and any follow-up procedures.

Final assessments will be conducted to gather comprehensive data on the treatment’s effectiveness and safety.

Who Can Join the Study?

  • The patient must have prostate cancer that has spread to other parts of the body and is sensitive to hormone treatment. The cancer should be confirmed by a test called a histology test, which examines tissue under a microscope.
  • The patient must agree to provide a sample of their cancer tissue, either as a block or slides. Tissue from bone is not acceptable.
  • The patient must have a test result showing PTEN deficiency, which is a specific characteristic of the cancer.
  • The patient must have cancer that has spread, shown by at least one bone or soft tissue lesion, which can be seen and measured using scans like CT (Computed Tomography) or MRI (Magnetic Resonance Imaging). A special scan called PSMA PET alone is not enough.
  • The patient must be suitable for treatment with abiraterone and steroid therapy.
  • The patient must be receiving ongoing ADT (Androgen Deprivation Therapy) with medications like GnRH analogue, LHRH agonists or antagonist, or have had a bilateral orchiectomy (surgical removal of both testicles).
  • The patient must have a performance status of 0 to 1, which means they are fully active or have some symptoms but can carry out light work. There should be no worsening of their condition in the last two weeks, and they should have a life expectancy of at least 12 weeks.
  • The patient must be able and willing to swallow and keep oral medication.
  • The patient must complete certain questionnaires about pain and fatigue, as well as keep a diary of any pain medication they take during the screening period.
  • The patient must agree to either abstain from heterosexual intercourse or use contraceptive methods and agree not to donate sperm during the study.

Who Cannot Join the Study?

  • Patients who do not have metastatic hormone-sensitive prostate cancer with PTEN deficiency cannot participate. Metastatic means the cancer has spread to other parts of the body. Hormone-sensitive means the cancer responds to hormone therapy. PTEN deficiency refers to a specific genetic change in the cancer cells.
  • Only male patients are eligible for this study.
  • Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

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
NH Hospital a.s. Horovice Czechia
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Klinikum Nuernberg Nürnberg Germany
Haga Hospital Hague The Netherlands
Centre Antoine Lacassagne Nice France
Institut Jules Bordet Anderlecht Belgium
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Hospital Foch Suresnes France
Universitair Ziekenhuis Gent Gent Belgium
Charite Research Organisation GmbH Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Tergooiziekenhuizen Hilversum The Netherlands
Az Maria Middelares Gent Gent Belgium
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Fakultni Nemocnice Bulovka Prague Czechia
Urocentrum Praha s.r.o. Prague Czechia
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Multiprofessional Hospital For Active Treatment Park Hospital Ltd. Branipole Bulgaria
Privatna Urologicka Ambulancia s.r.o. Trencin Slovakia
Urologische Gemeinschaftspraxis Wesel Germany
Hospital Universitario Ramon Y Cajal Madrid Spain
Hospital Universitario Central De Asturias Oviedo Spain
Centre Hospitalier Intercommunal De Cornouaille Quimper France
Hospital Universitario Virgen Macarena Sevilla Spain
Urologicum Duisburg Duisburg Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Medikard s.r.o. Presov Slovakia
Bravis Ziekenhuis Roosendaal The Netherlands
Centre Hospitalier Universitaire De Rennes Rennes France
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Centre Hospitalier Lyon Sud Pierre Benite France
Uroexam spol. s r.o. Nitra Slovakia
Nasz Lekarz Przychodnie Medyczne Sp. z o.o. Torun Poland
Urologie Neandertal Mettmann Germany
Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum Herne Germany
Ifoxgqju Rallvkqo Dp Ckqkul Da Msckaggbgli Montpellier France
Uzkmbbjlgd Mjehbpl Ctrvtp Hibyidcmtreoflysx Hamburg Germany
Hqzjropr Uejkqpkxgghnd Mfforwf Dk Vvslajphxp Santander Spain
Iihrnhqh Mxhijhgdsn Mypeqlprxc Paris France
Canpuu sqdebl Bratislava Slovakia
Uivaoqzjjx Swyk syoebb Sala Slovakia
Ucb ctxthv sifdel Bratislava Slovakia
Bzlwqxih Uougfulxqm Hozanmqe Ckopqo Besançon France
Sdq Elnxfzaxa Hzqotrzv Tbbtbev Tilburg The Netherlands
Uuszzwmjtunxbxkifipyj Myinvmmk Aam Munster Germany
Nsovdiom Inpizcxl Oggpkmrua Ibx Mahrr Sxprokmqmyesydabihjdtfttntag Iesycicr Bhhfusrd Cracow Poland
Uyewsaitvhztyz Cmftbpo Kxrxmqmpn Gdansk Poland
Hovwzlzp Da Lg Ssjic Ckvb I Sutp Pxh Barcelona Spain
Iimzbutr Crdayg Dvtgbmlbuwxkqnuic L'hospitalet De Llobregat Spain
Imdmhfva Bsfhovrq Bordeaux France
Ichahads Pddbylqtarcacyr Cdznkt Csseab Marseille France
Uwerhnkwjv Sraswqmbhwo Htmarhim Fgp Aubipv Tmmpkeqln Is Olmqdzph Egp Sofia Bulgaria
Hidkauac Uzglxnxnpwemhc Snfnujcied &ewtnbt Haqmzha di Hpmtettamlw STRASBOURG, Alsace France

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
03.05.2024
Bulgaria Bulgaria
Not recruiting
03.05.2024
Czechia Czechia
Not recruiting
03.05.2024
France France
Not recruiting
03.05.2024
Germany Germany
Not recruiting
03.05.2024
Poland Poland
Not recruiting
03.05.2024
Slovakia Slovakia
Not recruiting
03.05.2024
Spain Spain
Not recruiting
03.05.2024
The Netherlands The Netherlands
Not recruiting
03.05.2024

Trial locations

Capivasertib is a medication being studied for its potential to treat prostate cancer. It works by targeting specific pathways in cancer cells that are involved in their growth and survival. In this trial, it is being tested to see if it can help slow down the progression of prostate cancer in patients who have a deficiency in a gene called PTEN.

Abiraterone is a medication used to treat prostate cancer. It works by reducing the levels of male hormones in the body, which can help slow the growth of cancer cells. In this trial, abiraterone is used in combination with capivasertib to see if the two medications together can be more effective in treating prostate cancer.

Metastatic Hormone-sensitive Prostate Cancer Characterised by PTEN Deficiency – This is a type of prostate cancer that has spread to other parts of the body and still responds to hormone therapy. It is characterized by a deficiency in the PTEN gene, which normally helps regulate cell growth. The absence of PTEN can lead to uncontrolled cell division and tumor growth. As the disease progresses, cancer cells may continue to spread to bones and other organs. The progression is often monitored through imaging techniques to assess changes in tumor size and spread.

Trial ID:
2023-504998-20-00
Protocol code:
D361BC00001
Trial Phase:
Therapeutic confirmatory (Phase III)

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