RecruitingPHASE2INTERVENTIONAL

A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer

This study is for men with prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to standard hormone therapy (castration-resistant). We are investigating a new treatment called Inavolisib, given alongside another drug, Enzalutamide. This combination will be compared to other treatments doctors might usually suggest, such as another type of hormone therapy (ARPi) or chemotherapy (Docetaxel). The main goal is to see how well this new combination works in slowing down the cancer and if it's safe for patients. Participants would have already received one previous hormone therapy for their prostate cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

100

Start

11 Mar 2026

Estimated completion

30 Jul 2029

Metastatic Castration-Resistant Prostate Cancer

What is this study about?

This study, called a clinical trial, is looking for a new and better way to treat prostate cancer that has spread to other parts of the body. This type of cancer is called 'metastatic' and 'castration-resistant' because it has continued to grow even when hormone treatments are used to lower testosterone levels.

Researchers want to see if a new drug called Inavolisib, when added to an existing treatment called Enzalutamide, can be more effective than other standard treatments. The study will compare this new combination to other hormone therapies or Docetaxel chemotherapy, which are current options for men in this situation. The aim is to find out if Inavolisib and Enzalutamide can help slow down the cancer's growth and improve outcomes for patients.

This is a Phase 2 study, meaning it's still in the early stages of testing for effectiveness and safety on a larger group of people. Participants in this study would have already tried one type of advanced hormone therapy, and their cancer has since progressed. We will also be looking at specific 'biomarkers' in tumour samples, which are features within the cancer cells that might help us understand who could benefit most from Inavolisib.

Key takeaways

Tests a new treatment (Inavolisib + Enzalutamide) for advanced prostate cancer.
Compares it to standard treatments like other hormone therapies or Docetaxel chemotherapy.
For men whose prostate cancer has spread and is no longer responding to initial hormone therapy.
Will look at specific cancer cell features (biomarkers) to understand treatment response.
Participation involves regular hospital visits, tests, and closely monitored medication.

Who may be eligible?

To join this study, you must be a man with a confirmed diagnosis of prostate cancer that has spread and is no longer responding to hormone therapy. Your cancer must be getting worse, either by rising PSA levels, new bone lesions on a scan, or growth in soft tissues like lymph nodes. You should have already received one type of advanced hormone therapy (like abiraterone, apalutamide, enzalutamide, or darolutamide) for your prostate cancer.

There are also some general health requirements. For example, you should be able to perform your daily activities with little or no difficulty (as measured by something called an ECOG score of 0 or 1). Your blood sugar levels, both fasting and over time (HbA1c), need to be within a healthy range.

Some things would mean you couldn't join. For instance, if you have prostate cancer that has spread to your liver, or if you've already had certain types of targeted therapy that work on similar pathways as Inavolisib. Also, if you have Type 1 or Type 2 diabetes, or if you've had certain chemotherapy treatments for advanced prostate cancer, you might not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man with prostate cancer that has spread?
Has your prostate cancer continued to grow despite hormone therapy?
Have you had one previous advanced hormone treatment (like Enzalutamide, Abiraterone, Apalutamide, or Darolutamide)?
Are your blood sugar levels generally healthy (no diabetes)?
Can you generally do your daily activities without much trouble?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new drug combination (Inavolisib plus Enzalutamide) or a standard treatment chosen by your doctor (another hormone therapy or chemotherapy). This will be decided randomly, like flipping a coin. You will have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You'll need to provide a sample of your tumour tissue, if available, to help us understand your cancer better. The study will involve taking study medication as prescribed, and your doctors and nurses will closely monitor you. The total length of your participation will depend on how you respond to the treatment and the study's protocol, but it will involve ongoing assessments as long as you are on treatment and potentially follow-up after you stop.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't yet widely available, and it helps contribute to medical knowledge that could benefit future patients. However, like all medications, Inavolisib and the other treatments have potential side effects, some of which could be serious. The study team will explain all known side effects in detail and carefully monitor you throughout the trial. It's important to remember that you can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (39)

VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDS
Verified postcode
Los Angeles, United States· Recruiting
UCSF
Verified postcode
San Francisco, United States· Recruiting
Holden Comprehensive Cancer Center
Verified postcode
Iowa City, United States· Recruiting
Montefiore Einstein Cancer Center
Verified postcode
The Bronx, United States· Recruiting
Lifespan Cancer Institute
Verified postcode
Providence, United States· Recruiting
Carolina Urologic Research Center
Verified postcode
Myrtle Beach, United States· Recruiting
Royal North Shore Hospital-Pacific Hwy
Verified postcode
St Leonards, Australia· Recruiting
Sunshine Coast University Hospital
Verified postcode
Birtinya, Australia· Recruiting
Royal Brisbane & Womens Hospital
Verified postcode
Herston, Australia· Recruiting
Box Hill Hospital
Verified postcode
Box Hill, Australia· Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Verified postcode
Porto Alegre, Brazil· Recruiting
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Verified postcode
Santo André, Brazil· Recruiting

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This means your prostate cancer has spread beyond the prostate (metastatic) and is still growing even though your hormone levels are very low from previous treatments (castration-resistant).

What is Inavolisib?

Inavolisib is an investigational drug, meaning it's still being tested. It works by targeting a specific pathway in cancer cells to try and stop them from growing.

Will I definitely get the new drug?

No, you might receive the new combination of Inavolisib and Enzalutamide, or you might receive one of the standard treatments (either another hormone therapy or chemotherapy). Which treatment you get will be decided randomly.

What's a 'biomarker'?

A biomarker is a specific feature within your cancer cells that can give us clues about how your cancer might behave or how it might respond to certain treatments.

How long would I be in the study?

The length of time you'd be in the study depends on how you respond to the treatment. You would continue receiving treatment as long as it is working and you are tolerating it well.

How to find out more

Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below.

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.