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New hope for tough prostate cancer: drug combo trial launches

NCT ID NCT07287150

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 7 times

Summary

This study tests whether a new combination of two drugs, inavolisib and enzalutamide, works better than standard treatments for men with metastatic castration-resistant prostate cancer that has progressed after one prior therapy. About 100 men will be randomly assigned to receive either the new combo or a doctor's choice of standard drugs. The main goal is to see if the combo delays cancer growth on scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inavolisib and enzalutamide
What this could lead to
If successful, this could offer a new targeted treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is an early Phase 2 trial with only 100 participants, so results may not apply to everyone. The combination may cause side effects or not improve outcomes compared to existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

    RECRUITING

    Ankara, 6590, Turkey (Türkiye)

  • Asan Medical Center.

    RECRUITING

    Seoul, 05505, South Korea

  • Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • C.H. Regional Reina Sofia - PPDS

    RECRUITING

    Córdoba, 14004, Spain

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

    RECRUITING

    Santo André, São Paulo, 09060-650, Brazil

  • Carolina Urologic Research Center

    RECRUITING

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

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69008, France

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

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • EDOG - Institut Bergonie - PPDS

    RECRUITING

    Bordeaux, Gironde, 33000, France

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, Lombardy, 20133, Italy

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

    RECRUITING

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

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    RECRUITING

    Valencia, 46009, Spain

  • Gustave Roussy

    RECRUITING

    Villejuif, Val-de-Marne, 94805, France

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

    RECRUITING

    Mexico City, Mexico CITY (federal District), 3100, Mexico

  • Holden Comprehensive Cancer Center

    RECRUITING

    Iowa City, Iowa, 52242-1009, United States

  • Hospital MAC León

    RECRUITING

    León, Guanajuato, 37530, Mexico

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Cruces

    RECRUITING

    Barakaldo, Vizcaya, 48903, Spain

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

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

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Instituto Nacional de Cancer - INCa

    RECRUITING

    Rio de Janeiro, 20230-130, Brazil

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    RECRUITING

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

  • Istituti Fisioterapici Ospitalieri

    RECRUITING

    Rome, Lazio, 00144, Italy

  • Izmir Medical Point Hospital

    RECRUITING

    Izmir, 35101, Turkey (Türkiye)

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Koc Universitesi Hastanesi

    RECRUITING

    Istanbul, 41380, Turkey (Türkiye)

  • Lifespan Cancer Institute

    RECRUITING

    Providence, Rhode Island, 02903-4923, United States

  • Medical Park Seyhan Hospital

    RECRUITING

    Seyhan, 1140, Turkey (Türkiye)

  • Montefiore Einstein Cancer Center

    RECRUITING

    The Bronx, New York, 10461, United States

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

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Productos y Servicios Oncologicos Acacias SA de CV

    RECRUITING

    Benito Juárez, Mexico CITY (federal District), 3240, Mexico

  • Royal Brisbane & Womens Hospital

    RECRUITING

    Herston, Queensland, 4006, Australia

  • Royal North Shore Hospital-Pacific Hwy

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggido, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Studienpraxis Urologie

    RECRUITING

    Nürtingen, 72622, Germany

  • Sunshine Coast University Hospital

    RECRUITING

    Birtinya, Queensland, 4575, Australia

  • The Royal Marsden in Sutton, Surrey - Downs Rd

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • UCSF

    RECRUITING

    San Francisco, California, 94115, United States

  • Universitätsklinikum Freiburg

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Münster

    RECRUITING

    Münster, 48149, Germany

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

    RECRUITING

    Los Angeles, California, 90073-1003, United States

  • VM Medical Park Samsun Hastanesi

    RECRUITING

    Atakum, 55200, Turkey (Türkiye)

  • Velindre Cancer Centre

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.