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

NCT07287150 · Hoffmann-La Roche
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Official title
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
About this study
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
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 design
Enrollment target: 100 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-11
Estimated completion: 2029-07-30
Last updated: 2026-07-06
Interventions
Drug: InavolisibDrug: EnzalutamideDrug: AbirateroneDrug: Docetaxel
Primary outcomes
  • Radiographic Progression-free Survival (rPFS) (Up to approximately 5 years)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below. · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. and Canada)
ContactFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (39)
VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDSRecruiting
Los Angeles, California, United States
UCSFRecruiting
San Francisco, California, United States
Holden Comprehensive Cancer CenterRecruiting
Iowa City, Iowa, United States
Montefiore Einstein Cancer CenterRecruiting
The Bronx, New York, United States
Lifespan Cancer InstituteRecruiting
Providence, Rhode Island, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
Royal North Shore Hospital-Pacific HwyRecruiting
St Leonards, New South Wales, Australia
Sunshine Coast University HospitalRecruiting
Birtinya, Queensland, Australia
Royal Brisbane & Womens HospitalRecruiting
Herston, Queensland, Australia
Box Hill HospitalRecruiting
Box Hill, Victoria, Australia
Irmandade Da Santa Casa de Misericordia de Porto AlegreRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e OncologiaRecruiting
Santo André, São Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDSRecruiting
São José do Rio Preto, São Paulo, Brazil
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESPRecruiting
São Paulo, Brazil
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Centre de recherche du Centre Hospitalier de l'Universite de MontrealRecruiting
Montreal, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
EDOG - Institut Bergonie - PPDSRecruiting
Bordeaux, Gironde, France
Centre Léon BérardRecruiting
Lyon, France
Institut Paoli CalmettesRecruiting
Marseille, France
Universitätsklinikum Hamburg-EppendorfRecruiting
Hamburg, Germany
Studienpraxis UrologieRecruiting
Nürtingen, Germany
Istituti Fisioterapici OspitalieriRecruiting
Rome, Lazio, Italy
Ospedale San Raffaele S.r.l. - PPDSRecruiting
Milan, Lombardy, Italy
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggido, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical Center.Recruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hospital Universitario CrucesRecruiting
Barakaldo, Vizcaya, Spain
C.H. Regional Reina Sofia - PPDSRecruiting
Córdoba, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Fundacion Instituto Valenciano de Oncologia (IVO)Recruiting
Valencia, Spain
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci HastanesiRecruiting
Ankara, Turkey (Türkiye)
VM Medical Park Samsun HastanesiRecruiting
Atakum, Turkey (Türkiye)
Koc Universitesi HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Izmir Medical Point HospitalRecruiting
Izmir, Turkey (Türkiye)
Medical Park Seyhan HospitalRecruiting
Seyhan, Turkey (Türkiye)
The Royal Marsden in Sutton, Surrey - Downs RdRecruiting
Sutton, Surrey, United Kingdom
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer · TrialPath