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Looking for participantsPhase2

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT07287150

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Inavolisib (drug), Enzalutamide (drug), Abiraterone (drug), Docetaxel (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
Inavolisib — drug: Inavolisib will be administered orally as per the schedule specified in the protocol. · Enzalutamide — drug: Enzalutamide will be administered orally as per the schedule specified in the protocol. · Abiraterone — drug: Abiraterone will be administered orally as per the schedule specified in the protocol. · Docetaxel — drug: Docetaxel will be administered intravenously as per the schedule specified in the protocol.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
100
Started
2026-03-11
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic castration-resistant prostate cancer
  • • Phase2 - 100 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic castration-resistant prostate cancer
  • • Male only

Where?

  • • Sutton - The Royal Marsden in Sutton, Surrey - Downs Rd
  • • Cardiff - Velindre Cancer Centre

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Metastatic Castration-Resistant Prostate Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

PSA

What the study is looking for

  • ✓confirmed by testing a sample adenocarcinoma of the prostate without small-cell or neuroendocrine features
  • ✓Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide,...
  • ✓Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in...
  • ✓activity scale (ECOG) Performance Status of 0 or 1
  • ✓Fasting glucose \<126 mg/dL and HbA1c \< 6%

Who cannot take part

  • ✗Presence of liver metastasis
  • ✗Type 1 or Type 2 diabetes mellitus
  • ✗Other concurrent anti-cancer therapy except for androgen deprivation therapy
  • ✗Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion...
See the full 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 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% 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

Where Is This Study? (2 UK sites)

The Royal Marsden in Sutton, Surrey - Downs Rd

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

How to Get in Touch

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

Sponsor contact

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

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10