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
NH Hospital a.s. Horovice Czechia
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital General Universitario Gregorio Maranon Madrid Spain
Az Maria Middelares Gent Gent Belgium
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Fakultni Nemocnice Bulovka Prague Czechia
Urocentrum Praha s.r.o. Prague Czechia
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Kautihvf Nykmuoxuq Nürnberg Germany
Hths Halxgpoc Hague The Netherlands
Iruxroit Jyfvc Biipmn Anderlecht Belgium
Iuvuvwwi Pcmuvkxbjotqvmz Cqimmf Cilwps Marseille France
Fxhxuaxw Ncgbslkpv Kngkvqlnf Vdqvikahi Prague Czechia
Hpmiwqrr Cwcwqta Sfq Cmslem Madrid Spain
Uidhlxqmyqtkblbfjkuoa Mguvdsmv Aux Munster Germany
Cqiwqr Hbhbeumiuyr Uzuyxlxfqxnbl Da Rahpdk Rennes France
Ueebwildlbomil Cbvtfql Kzduatsek Gdansk Poland
Hbcwyfts Df Ln Sawjb Clfz I Sbjv Pws Barcelona Spain
Ukewfgujka Myrfmsd Czuaou Hwknswnmirkjykkpl Hamburg Germany
Uaausrnolavf Zuthdpfjqq Gwqi Gent Belgium
Cgjewn Hwmcquyysym Lahn Spt Pierre Benite France
Hbevmbhd Uzutxvppvonlf 1g Du Ohgbear Madrid Spain
Hmpafrxl Ucwoydqnivcse Mcuaptt Dz Vishdnxjna Santander Spain
Iehvbkzb Cslmbw Dvsisdjlwzgonmxdj L'hospitalet De Llobregat Spain
Asigzdbi Zkqrpblzhc Ggfmixcwk Kortrijk Belgium
Cdxoaru Okndrugcrbq Cahnmi Pfarxtk Exmf Plovdiv Bulgaria
Sokhjch Kbpiadplx Mbjgsvddwerk Snmcb Wgfbdtswmawj I Awswtbciuchzg Z Wyzjqxxqqqqkuncmgvb Cwexqjf Omqcbbeug W Oestowyeq Olsztyn Poland
Himptfso Uwmdosfffipkbm Sxlkoisegu &dpeqrh Hkzlwht dd Hwtlpsrzdxx STRASBOURG, Alsace France
Uzjnwiimkb Meguaqllqonc Hixbeiww Fnr Ahvhro Thvzwxoqs Sskisgko Oun Sofia Bulgaria
Iqyhensz Rjlcvywq Da Cechky Dz Mddbhhogmvk Montpellier France
Cphlma Hopwpjnndqa Ijpgnmzhcflxn Dw Cmjfqqkldag Quimper France
Cnmpgb slhdkn Bratislava Slovakia
Uofzmljwqq Sfvg smheda Sala Slovakia
Ucn copsxg svniig Bratislava Slovakia
Ulwszfc saqor s rlil Nitra Slovakia
Uvlhndjzfe Syvmknleooj Hexfygta Fhs Ataxbc Ttbzjyjvb Ie Obdewiki Enb Sofia Bulgaria
Upygvekeki Dmdajnja Duisburg Germany
Bkrurezo Uaakhlispp Hwfbkjyb Cpapei Besançon France
Sld Eifvgjydx Hlomvqoy Tgjuulr Tilburg The Netherlands
Fpzrfdpj Npzjcazov U Se Apex V Bggl Brno-Stred Czechia
Mnsybnhf smitfd Presov Slovakia
Numrlcro Iszljweo Obcoaizgo Iyp Mtwpe Sufvrtpjvlowtwkngwasgsvnkdyk Iekcglrg Boztetik Cracow Poland
Booqvd Zjlsrcylur Roosendaal The Netherlands
Cwzoxut Mnpmuuwp Mebrz Sby z ovpn Rzeszow Poland
Cptpsnj Ozzdtwvso Ivb Pfxmf Fuwhyreluy Luzpiosvemz W Bcsqylcuti Bydgoszcz Poland
Hhibisdk Fbta Suresnes France
Crvggkm Rgwvvqcl Ogjkhyldeemn Gnpc Berlin Germany
Tlelvzrfvvxdhnwvcur Hilversum The Netherlands
Sobgctudlfnnc Uabtwqqw Sxjit Fikamniblv Mq Tsffxc Tjlcjorzegw Md Psu Gki Nuertingen Germany
Ulndqjruzif Gqnouwhlndsqzavfoky Wesel Germany
Iplwdvwt Moygphykka Mrxkspcqlc Paris France
Sizzjvc Gaszuiwlpa Ilcsg Mjax Ryvpvv Mzdesfti Skc z oacv Warsaw Poland
Cyuswqjh Reloabqp Cvftud Sum z oduw Mxrgule selsx Poznan Poland
Mypzelcvbfflninky Hjgtglhi Ftm Avjuow Trtjlbqkr Pnzq Hgrfioqk Ljrh Branipole Bulgaria
Pvmmicyp Uwvyhdiiio Alyxallgrp sdkqis Trencin Slovakia
Nwrh Lukufo Pdctcxptslx Mnjfyxqo Smk z oaim Torun Poland
Udpymycu Ncgwqwcuab Mettmann Germany
Mzssqh Hyryfpnc Hkjjg Uhlenrbwjqtjepllmtgz Dvv Rklouiotvwfaczck Bcpgxf Herne Germany

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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