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

NCT07287150 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: CO458132025-521327-67-00
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 20

Brief 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.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Radiographic Progression-free Survival (rPFS)

  Up to approximately 5 years

Secondary Outcomes (7)

• Percentage of Participants with Confirmed Composite Response Rate (RR)

  Up to approximately 5 years

• Percentage of Participants with Confirmed Prostate-Specific Antigen 90 (PSA90)

  Up to approximately 5 years

• Percentage of Participants with Confirmed Prostate-Specific Antigen 50 (PSA50)

  Up to approximately 5 years

• Objective Response Rate (ORR)

  Up to approximately 5 years

• Duration of Response (DOR)

  Up to approximately 5 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants will receive Inavolisib plus enzalutamide

Drug: Inavolisib; Drug: Enzalutamide

Arm 2

ACTIVE COMPARATOR

Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel

Drug: Enzalutamide; Drug: Abiraterone; Drug: Docetaxel

Interventions

Inavolisib DRUG

Inavolisib will be administered orally as per the schedule specified in the protocol.

Arm 1

Docetaxel DRUG

Docetaxel will be administered intravenously as per the schedule specified in the protocol.

Arm 2

Enzalutamide DRUG

Enzalutamide will be administered orally as per the schedule specified in the protocol.

Arm 1; Arm 2

Abiraterone DRUG

Abiraterone will be administered orally as per the schedule specified in the protocol.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (20)

UCSF

San Francisco, California, 94115, United States

RECRUITING

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

RECRUITING

Montefiore Einstein Cancer Center

The Bronx, New York, 10461, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572-4607, United States

RECRUITING

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Royal Brisbane & Womens Hospital

Herston, Queensland, 4006, Australia

RECRUITING

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

RECRUITING

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, São Paulo, 09060-650, Brazil

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center.

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

C.H. Regional Reina Sofia - PPDS

Córdoba, 14004, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

MeSH Terms

Interventions

inavolisib; enzalutamide; abiraterone; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CO45813 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 17, 2025
• Study Start: March 11, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (2); FR (1); KR (5); US (4); AU (3); CA (3); BR (2)