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A study evaluating the efficacy and safety of inavolisib and enzalutamide in patients with metastatic castration-resistant prostate cancer

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What is this trial about?

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

This study focuses on individuals with Metastatic Castration-Resistant Prostate Cancer, which is a type of advanced cancer that has spread to other parts of the body and continues to grow even after medical treatments have lowered hormone levels. The purpose of the study is to evaluate the effectiveness and safety of a combination treatment consisting of inavolisib and enzalutamide. In this trial, participants may receive the combination of these two drugs or be assigned to a different treatment chosen by their doctor, such as abiraterone or docetaxel. Abiraterone and enzalutamide belong to a group of medications known as androgen receptor pathway inhibitors, which work by blocking the hormones that help the cancer grow. Docetaxel is a type of chemotherapy used to kill cancer cells.

During the study, researchers will monitor how the cancer responds to the treatments. One way they track this is through radiographic progression-free survival, which measures the length of time during and after treatment that the cancer does not grow or spread as seen on imaging tests like scans. Other measurements include tracking prostate-specific antigen, which is a protein found in the blood that can indicate the presence or activity of prostate cancer. The study also looks at the overall length of time patients live and monitors any side effects or adverse events that may occur during the course of the medication.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study assignment

    After joining the study, an assignment is made to one of two different treatment paths.

    The specific treatment path is determined through a process called randomization, which is similar to a lottery to ensure unbiased results.

  2. Step 2

    Treatment group 1: combination therapy

    The first treatment path involves taking a combination of two medications: inavolisib and enzalutamide.

    inavolisib is taken as a film-coated tablet by mouth.

    enzalutamide is taken as a pill by mouth at a dose of 160 mg.

  3. Step 3

    Treatment group 2: comparison therapy

    The second treatment path involves receiving a treatment chosen by a physician. this may be an androgen receptor pathway inhibitor (a type of medication used for prostate cancer) or docetaxel.

    If abiraterone is chosen, it is taken by mouth at a dose of 1000 mg.

    If docetaxel is chosen, it is administered through an intravenous line (a tube inserted into a vein) at a dose of 75 mg/m2, which is calculated based on body surface area.

Who can join the trial?

10 criteria

  • You must be a male patient.
  • You must have a confirmed type of prostate cancer called adenocarcinoma, which is a cancer that starts in the cells that produce fluid in the prostate, and it must not have small-cell or neuroendocrine features, which are specific, more aggressive types of cancer cells.
  • Your cancer must be metastatic castration-resistant prostate cancer, which means the cancer has spread to other parts of the body and is no longer responding well to hormone therapy that lowers testosterone.
  • Your cancer must show signs of progression, meaning it is getting worse. This can be shown by a rising PSA (a protein produced by the prostate that acts as a marker for cancer levels), by new growth in soft tissues, or by new spots on the bones seen on a bone scan.
  • You must have previously taken exactly one type of second-generation androgen receptor inhibitor (a type of hormone therapy such as abiraterone, apalutamide, enzalutamide, or darolutamide).
  • You must have stopped your previous hormone therapy a specific amount of time before starting this study: enzalutamide or apalutamide must have been stopped at least 3 weeks ago, while abiraterone or darolutamide must have been stopped at least 2 weeks ago.
  • If you previously took a first-generation androgen receptor inhibitor (like bicalutamide), it must have been stopped more than 6 weeks ago.
  • You must have a tumor tissue specimen (a small sample of the cancer) that is of good enough quality and amount for doctors to test for biomarkers, which are natural substances in the body that can help identify specific characteristics of the cancer.
  • Your fasting glucose (the amount of sugar in your blood after not eating for a while) must be 100 mg/dL or less.
  • Your HbA1c (a blood test that shows your average blood sugar levels over the past few months) must be less than 5.7%.

Who cannot join the trial?

6 criteria

  • Having liver metastasis, which means that the cancer has spread to the liver.
  • Having previously taken any medicine that blocks the PI3K, AKT, or mTOR pathway, which are specific biological signals inside cells that help cancer grow.
  • Having Type 1 or Type 2 diabetes, which are conditions involving high blood sugar levels.
  • Currently receiving other anti-cancer therapies, or treatments used to fight cancer.
  • Having used certain drugs that affect CYP2C8 or CYP3A4 enzymes within a specific timeframe; these enzymes are proteins in the body that help break down and clear medicines.
  • Receiving a blood transfusion just to qualify for the study or within 28 days before joining the study.
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Investigated drugs

  • Inavolisib

    is an experimental medication taken by mouth that is being tested to see how well it works when used alongside another drug to treat certain types of advanced prostate cancer.

  • Enzalutamide

    is an oral medication used in this study to help block the hormones that allow prostate cancer cells to grow.

  • Docetaxel

    is a type of chemotherapy drug given through a vein to help slow down the growth of cancer cells.

  • Abiraterone

    is an oral medication used as a comparison treatment to help lower the amount of hormones in the body that fuel the growth of prostate cancer.

What is already known about the treatment

  • Inavolisib

    This medication is taken as a film-coated tablet by mouth and is currently being studied for its effectiveness in treating advanced cancers. It belongs to a group of drugs called PI3K inhibitors, which work by blocking a specific protein in cells that helps them grow and multiply uncontrollably. By stopping this signal, the drug aims to slow down the progression of the disease.

  • Docetaxel

    This drug is administered through an intravenous injection directly into a vein and is widely used in medical practice to treat various types of cancer. It is classified as a chemotherapy medication that works by preventing cancer cells from dividing and replicating. It does this by interfering with the internal scaffolding of the cell, causing the cancer cells to die.

  • Enzalutamide

    This is an oral medication used to treat advanced prostate cancer and is already established in medical treatment. It belongs to a class of drugs known as androgen receptor pathway inhibitors, which work by blocking the hormones that cancer cells need to grow. By preventing these hormones from attaching to cancer cells, the drug helps stop the cancer from spreading.

  • Abiraterone

    Taken as a pill by mouth, this medication is a well-known treatment used to manage advanced prostate cancer. It is classified as a hormone therapy that works by interfering with the production of androgens, which are the male hormones that fuel certain cancer cells. By lowering the amount of these hormones in the body, the drug helps limit the growth of the tumor.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer - This is a type of cancer that develops in the prostate gland and has spread to other parts of the body. It occurs when prostate cancer continues to grow even though testosterone levels in the body are being kept at very low levels. The disease typically progresses as the cancer cells find new ways to grow without needing high amounts of male hormones. As it advances, the cancer cells can spread through the bloodstream or lymphatic system to distant organs or bones.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521327-67-00Protocol codeCO45813Estimated enrolment100 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).