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A Study of Inavolisib for Metastatic Prostate Cancer

This study is testing a new combination treatment for men with metastatic castration-resistant prostate cancer (mCRPC), which is prostate cancer that has spread and is no longer responding to standard hormone therapy. You might be eligible if you are 18 or older, have this type of prostate cancer, and have already received one other hormone therapy. The study will compare a new drug called inavolisib, given with enzalutamide, against other standard treatments like enzalutamide, abiraterone, or docetaxel. Researchers want to see if the inavolisib combination can help you live longer without your cancer getting worse (this is called radiographic progression-free survival, or rPFS). The study is looking for about 100 participants, but its current status is unclear.

Study design
This study is an interventional study, meaning participants will receive specific treatments. It aims to enroll 100 men.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 5 years to measure how long they live without their cancer getting worse.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07287150

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Hoffmann-La Roche
~100 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:InavolisibEnzalutamideAbirateroneDocetaxel

At a glance

Recruiting sites
47 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Progression-free Survival (rPFS)
Measured over Up to approximately 5 years

Conditions

Metastatic Castration-Resistant Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

47 sites across 29 states
Turkey (Türkiye)5
South Korea4
Spain3
California2
Queensland2
São Paulo2
Brazil2
Quebec2

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features
Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA \>=1 ng/mL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Bone disease progression, defined by PCWG3 criteria, with two or more new metastatic bone lesions on a whole-body radionuclide bone scan
Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for hormone- sensitive prostate cancer (HSPC) or CRPC
Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Fasting glucose \<100 mg/dL and HbA1c \< 5.7%

Exclusion

Presence of liver metastasis
Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K/AKT/mTOR pathway
Type 1 or Type 2 diabetes mellitus
Prior treatment for mCRPC with cytotoxic chemotherapy or novel hormonal treatments (e.g., androgen receptor degraders, CYP11 inhibitors), with the following treatments permitted: Prior docetaxel in mHSPC, providing no evidence of disease progression occurred during treatment or within 6 months of treatment completion; Prior docetaxel in the adjuvant or neoadjuvant setting providing no evidence of disease progression occurred during treatment or within 12 months of treatment completion; Prior treatment with sipuleucel-T, with the last dose administered \>28 days prior to start of treatment; Prior PARPi therapy, as per local prescribing information, with the last dose administered \>14 days prior to start of treatment; One prior RLT or radiotherapeutic agent (e.g., PSMA-targeted RLT, Radium 223) with the last dose administered \>8 weeks prior to start of treatment
Other concurrent anti-cancer therapy except for androgen deprivation therapy
Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment
Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment

What this trial measures

  • Radiographic Progression-free Survival (rPFS)Up to approximately 5 years