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Metastatic Castration-Resistant Prostate CancerPhase 2InavoPCNCT07287150

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

A Phase 2 study testing Inavolisib, Enzalutamide and Abiraterone in people with Metastatic Castration-Resistant Prostate Cancer, run by Hoffmann-La Roche at 50 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Inavolisib, Enzalutamide and Abiraterone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
50 sitesin 12 countries
Study dates
11 Mar 2026to 30 Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 at least 12 weeks for 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 <126 mg/dL and HbA1c < 6%

Who cannot join

  • 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

Trial locations and contacts

50 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

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

50 sites in 12 countries

United States7 sites, 7 recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80124-5316

    Recruiting

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

    Recruiting

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

    Los Angeles, California, 90073-1003

    Recruiting

  • Grand Strand Regional Medical Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903-4923

    Recruiting

  • UCSF

    San Francisco, California, 94115

    Recruiting

  • Montefiore Einstein Cancer Center

    The Bronx, New York, 10461

    Recruiting

Other trials in United States

Brazil5 sites, 5 recruiting

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-074

    Recruiting

  • Instituto Nacional de Cancer - INCa

    Rio de Janeiro, 20230-130

    Recruiting

  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

    Santo André, São Paulo, 09060-650

    Recruiting

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

    São José do Rio Preto, São Paulo, 15090-000

    Recruiting

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

    São Paulo, 01246-000

    Recruiting

Other trials in Brazil

South Korea5 sites, 5 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center.

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Turkey (Türkiye)5 sites, 5 recruiting

  • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

    Ankara, 6590

    Recruiting

  • VM Medical Park Samsun Hastanesi

    Atakum, 55200

    Recruiting

  • Koc Universitesi Hastanesi

    Istanbul, 41380

    Recruiting

  • Izmir Medical Point Hospital

    Izmir, 35101

    Recruiting

  • Medical Park Seyhan Hospital

    Seyhan, 1140

    Recruiting

Other trials in Turkey (Türkiye)

Australia4 sites, 4 recruiting

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

    Recruiting

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    Recruiting

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

    Recruiting

  • Royal North Shore Hospital-Pacific Hwy

    St Leonards, New South Wales, 2065

    Recruiting

Other trials in Australia

France4 sites, 4 recruiting

  • EDOG - Institut Bergonie - PPDS

    Bordeaux, Gironde, 33000

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Recruiting

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94805

    Recruiting

Other trials in France

Germany4 sites, 4 recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Universitätsklinikum Münster

    Münster, 48149

    Recruiting

  • Studienpraxis Urologie

    Nürtingen, 72622

    Recruiting

Other trials in Germany

Italy4 sites, 4 recruiting

  • Istituto Oncologico Veneto - Sede di Castelfranco Veneto c/o Ospedale San Giacomo Apostolo

    Castelfranco Veneto, Veneto, 31033

    Recruiting

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20132

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

    Recruiting

  • Istituti Fisioterapici Ospitalieri

    Rome, Lazio, 00144

    Recruiting

Other trials in Italy

Spain4 sites, 4 recruiting

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903

    Recruiting

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009

    Recruiting

Other trials in Spain

Canada3 sites, 3 recruiting

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

    Montreal, Quebec, H2X 0A9

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Mexico3 sites, 3 recruiting

  • Productos y Servicios Oncologicos Acacias SA de CV

    Benito Juárez, Mexico CITY (federal District), 3240

    Recruiting

  • Hospital MAC León

    León, Guanajuato, 37530

    Recruiting

  • Health Pharma Professional Research S.A de C.V.

    Mexico City, Mexico CITY (federal District), 3100

    Recruiting

Other trials in Mexico

United Kingdom2 sites, 2 recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    Recruiting

  • The Royal Marsden in Sutton, Surrey - Downs Rd

    Sutton, Surrey, SM2 5PT

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Being tested
Inavolisib, Enzalutamide, Abiraterone, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

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

  • EnzalutamideDrug

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

  • AbirateroneDrug

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

  • DocetaxelDrug

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

Study groups in NCT07287150
Study groupRoleWhat they receive
Arm 1ExperimentalParticipants will receive Inavolisib plus enzalutamide
Receives: Drug: Inavolisib; Drug: Enzalutamide
Arm 2Active comparatorParticipants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel
Receives: Drug: Enzalutamide; Drug: Abiraterone; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression-free Survival (rPFS)

    Measured: Up to approximately 5 years

Secondary outcomes (7)

  1. Percentage of Participants with Confirmed Composite Response Rate (RR)

    Measured: Up to approximately 5 years

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

    Measured: Up to approximately 5 years

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

    Measured: Up to approximately 5 years

  4. Objective Response Rate (ORR)

    Measured: Up to approximately 5 years

  5. Duration of Response (DOR)

    Measured: Up to approximately 5 years

  6. Overall Survival (OS)

    Measured: Up to approximately 5 years

  7. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start11 Mar 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion30 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07287150
Sponsor's protocol ID
CO45813
Other IDs
2025-521327-67-00, 2025
Acronym
InavoPC
Status last verified
Nov 2026
First submitted
11 Dec 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inavolisib, Enzalutamide and Abiraterone in people with Metastatic Castration-Resistant Prostate Cancer, run by Hoffmann-La Roche at 50 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Brazil, South Korea, Turkey (Türkiye), Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-free Survival (rPFS) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07287150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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