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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

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

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Foundation Medicine GmbH Penzberg Germany
Istituto Oncologico Veneto Padua Italy
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Universitario De Cruces Barakaldo Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Couysf Lbkt Bxmsmj Lyon France
Uvfjnugtra Mrhnhcg Cymyqt Hsxnlfhiuplacixol Hamburg Germany
Iezumi Ikpcqwqu Fsyzvvdthvezr Ouifdsjqvef Rome Italy
Ijrqayez Cisbws Dykjmcbmixlywniwo L'hospitalet De Llobregat Spain
Uflazxrofmxullmeyrzxl Mgjyuhkz Ayq Munster Germany
Iensialv Pvtxrxpiyksfvhy Cmokkk Cvbpfv Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
13.03.2026
Germany Germany
Recruiting
13.03.2026
Italy Italy
Recruiting
13.03.2026
Spain Spain
Recruiting
13.03.2026

Trial locations

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.

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 ID:
2025-521327-67-00
Protocol code:
CO45813
Trial Phase:
Therapeutic exploratory (Phase II)

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