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NCT07287150PHASE2Recruiting

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

Hoffmann-La Roche

Start Date

3/11/2026

Completion Date

7/30/2029

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Inavolisib

DRUG

Enzalutamide

DRUG

Abiraterone

DRUG

Docetaxel

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Conditions

Metastatic Castration-Resistant Prostate Cancer

Locations

VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDS

Los Angeles, California 90073-1003

United States

UCSF

San Francisco, California 94115

United States

Holden Comprehensive Cancer Center

Iowa City, Iowa 52242-1009

United States

Montefiore Einstein Cancer Center

The Bronx, New York 10461

United States

Lifespan Cancer Institute

Providence, Rhode Island 02903-4923

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572-4607

United States

Royal North Shore Hospital-Pacific Hwy

St Leonards, New South Wales 2065

Australia

Sunshine Coast University Hospital

Birtinya, Queensland 4575

Australia

Royal Brisbane & Womens Hospital

Herston, Queensland 4006

Australia

Box Hill Hospital

Box Hill, Victoria 3128

Australia

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-074

Brazil

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, São Paulo 09060-650

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

São José do Rio Preto, São Paulo 15090-000

Brazil

Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP

São Paulo, 01246-000

Brazil

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Centre de recherche du Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec H2X 0A9

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

EDOG - Institut Bergonie - PPDS

Bordeaux, Gironde 33000

France

Centre Léon Bérard

Lyon, 69008

France

Institut Paoli Calmettes

Marseille, 13009

France

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

Studienpraxis Urologie

Nürtingen, 72622

Germany

Istituti Fisioterapici Ospitalieri

Rome, Lazio 00144

Italy

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy 20132

Italy

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center.

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hospital Universitario Cruces

Barakaldo, Vizcaya 48903

Spain

C.H. Regional Reina Sofia - PPDS

Córdoba, 14004

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Fundacion Instituto Valenciano de Oncologia (IVO)

Valencia, 46009

Spain

Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

Ankara, 6590

Turkey (Türkiye)

VM Medical Park Samsun Hastanesi

Atakum, 55200

Turkey (Türkiye)

Koc Universitesi Hastanesi

Istanbul, 41380

Turkey (Türkiye)

Izmir Medical Point Hospital

Izmir, 35101

Turkey (Türkiye)

Medical Park Seyhan Hospital

Seyhan, 1140

Turkey (Türkiye)

The Royal Marsden in Sutton, Surrey - Downs Rd

Sutton, Surrey SM2 5PT

United Kingdom