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Inavolisib plus enzalutamide for metastatic castration-resistant prostate cancer

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

PHASE2 · Hoffmann-La Roche · NCT07287150

This phase 2 trial will test whether adding inavolisib to enzalutamide helps biomarker-selected patients with metastatic castration-resistant prostate cancer who have already received one second-generation androgen-receptor pathway inhibitor.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexMale
SponsorHoffmann-La Roche (industry)
Drugs / interventionschemotherapy
Locations20 sites (San Francisco, California and 19 other locations)
Trial IDNCT07287150 on ClinicalTrials.gov

What this trial studies

This randomized phase 2 study compares the combination of the PI3K inhibitor inavolisib plus enzalutamide against a physician's choice of an alternative androgen-receptor pathway inhibitor or docetaxel in biomarker-selected patients with mCRPC. Eligible participants must have histologically confirmed prostate adenocarcinoma (no small-cell or neuroendocrine features), documented progression, one prior second-generation ARPi, and a suitable tumor tissue sample for biomarker testing. Participants are assigned to receive either the combination regimen or the comparator, and the trial will track safety, tumor response, and time-to-progression endpoints. The trial is conducted at several U.S. academic cancer centers and focuses on outcomes in a molecularly selected subgroup.

Who should consider this trial

Good fit: Men with metastatic castration-resistant prostate adenocarcinoma (no small-cell or neuroendocrine features) who have progressed after one prior second-generation AR pathway inhibitor and can provide a suitable tumor tissue sample are the intended candidates.

Not a fit: Patients lacking the required biomarker, those with small-cell or neuroendocrine prostate cancer, those who have had more than one prior second-generation AR inhibitor, or those unable to attend the U.S. study sites are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this combination could provide a new targeted treatment option that delays progression for biomarker-positive mCRPC patients.

How similar studies have performed: Targeting the PI3K/AKT pathway alongside androgen-receptor blockade has shown promising signals in biomarker-selected groups in other cancers and early prostate studies but remains investigational with mixed results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

San Francisco, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metastatic Castration-Resistant Prostate Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.