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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

10 criteria

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 trial?

3 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
Verified
Besançon, France
Fakultni Nemocnice Kralovske Vinohrady
Responsive
Prague, Czechia
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Capivasertib
Capivasertib is administered orally and is currently being studied in clinical trials for its potential use in treating metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for capivasertib is to improve outcomes in prostate cancer patients with specific genetic characteristics. At the molecular level, capivasertib works by inhibiting certain enzymes involved in cancer cell growth and survival, specifically targeting the AKT pathway. It is classified as a kinase inhibitor in pharmacology.
Abiraterone
Abiraterone is taken orally and is an established medication used in the treatment of prostate cancer, particularly in cases where the cancer is sensitive to hormone therapy. It is widely recognized in medical literature and is approved for use in various stages of prostate cancer. The primary therapeutic indication for abiraterone is to reduce the production of androgens, which can fuel the growth of prostate cancer cells. It works by inhibiting an enzyme called CYP17, which is crucial in the production of testosterone. Abiraterone is classified as an androgen biosynthesis inhibitor.

Investigated diseases

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.