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

September 2, 2026 updated by: Hoffmann-La Roche

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

This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

  • Name: Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below.
  • Phone Number: 888-662-6728 (U.S. and Canada)
  • Email: global-roche-genentech-trials@gene.com

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital-Pacific Hwy
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Hospital
      • Herston, Queensland, Australia, 4006
        • Recruiting
        • Royal Brisbane & Womens Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Recruiting
        • Instituto Nacional de Cancer - INCa
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-650
        • Recruiting
        • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre de recherche du Centre Hospitalier de l'Universite de Montreal
  • France
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon Berard
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Recruiting
        • EDOG - Institut Bergonie - PPDS
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Recruiting
        • Gustave Roussy
  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
      • Münster, Germany, 48149
        • Recruiting
        • Universitatsklinikum Munster
      • Nürtingen, Germany, 72622
        • Recruiting
        • Studienpraxis Urologie
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitätsklinikum Freiburg
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00144
        • Recruiting
        • Istituti Fisioterapici Ospitalieri
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37530
        • Recruiting
        • Hospital MAC León
    • Mexico CITY (federal District)
      • Benito Juárez, Mexico CITY (federal District), Mexico, 3240
        • Recruiting
        • Productos y Servicios Oncologicos Acacias SA de CV
      • Mexico City, Mexico CITY (federal District), Mexico, 3100
        • Recruiting
        • Health Pharma Professional Research S.A de C.V.
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center.
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • C.H. Regional Reina Sofia - PPDS
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain, 46009
        • Recruiting
        • Fundacion Instituto Valenciano de Oncologia (IVO)
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Recruiting
        • Hospital Universitario Cruces
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6590
        • Recruiting
        • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
      • Atakum, Turkey (Türkiye), 55200
        • Recruiting
        • VM Medical Park Samsun Hastanesi
      • Istanbul, Turkey (Türkiye), 41380
        • Recruiting
        • Koc Universitesi Hastanesi
      • Izmir, Turkey (Türkiye), 35101
        • Recruiting
        • Izmir Medical Point Hospital
      • Seyhan, Turkey (Türkiye), 1140
        • Recruiting
        • Medical Park Seyhan Hospital
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre Cancer Centre
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden in Sutton, Surrey - Downs Rd
  • United States
    • California
      • Los Angeles, California, United States, 90073-1003
        • Recruiting
        • VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDS
      • San Francisco, California, United States, 94115
        • Recruiting
        • UCSF
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • Recruiting
        • Holden Comprehensive Cancer Center
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Einstein Cancer Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903-4923
        • Recruiting
        • Lifespan Cancer Institute
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572-4607
        • Recruiting
        • Carolina Urologic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Participants will receive Inavolisib plus enzalutamide
Drug: Inavolisib
Inavolisib will be administered orally as per the schedule specified in the protocol.
Drug: Enzalutamide
Enzalutamide will be administered orally as per the schedule specified in the protocol.
Active Comparator: Arm 2
Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel
Drug: Enzalutamide
Enzalutamide will be administered orally as per the schedule specified in the protocol.
Drug: Abiraterone
Abiraterone will be administered orally as per the schedule specified in the protocol.
Drug: Docetaxel
Docetaxel will be administered intravenously as per the schedule specified in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic Progression-free Survival (rPFS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Overall Survival (OS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Percentage of Participants with Confirmed Composite Response Rate (RR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Percentage of Participants with Confirmed Prostate-Specific Antigen 90 (PSA90)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Percentage of Participants with Confirmed Prostate-Specific Antigen 50 (PSA50)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO45813
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521327-67-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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