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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Not possible to specify, Diseases [C] - Neoplasms [C04]

Trial duration

13 Apr 2026 → ongoing

Decision date (initial)

2026-03-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of inavolisib plus enzalutamide compared with the investigator's choice of control arm (androgen receptor pathway inhibitor (ARPi) switch [enzalutamide or abiraterone] or docetaxel) with respect to radiographic progression-free survival (rPFS)

Secondary objectives 3

1. To evaluate the efficacy of inavolisib plus enzalutamide compared with the investigator's choice of control arm (androgen receptor pathway inhibitor (ARPi) switch [enzalutamide or abiraterone] or docetaxel) with respect to Confirmed Composite Response Rate (RR)
2. To evaluate the efficacy of inavolisib plus enzalutamide compared with the investigator's choice of control arm (ARPi switch [enzalutamide or abiraterone] or docetaxel) with respect to Confirmed prostate-specific antigen 90 (PSA90) and prostate-specific antigen 50 (PSA50),objective response rate (ORR), duration of response (DOR) and overall survival (OS)
3. To evaluate the safety of inavolisib plus enzalutamide compared with the investigator's choice of control arm (ARPi switch [enzalutamide or abiraterone] or docetaxel) with respect to incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0, change from baseline in selected vital signs, and change from baseline in selected clinical laboratory test results.

Conditions and MedDRA coding

Metastatic Castration-Resistant Prostate Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features
2. 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
3. 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 castrate-resistant prostate cancer (CRPC)
4. Prior ARPi must have been discontinued as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate or darolutamide within 2 weeks prior to start of treatment. In addition, no evidence of radiographic disease progression should have occurred during prior enzalutamide, apalutamide or darolutamide treatment or intolerable toxicity to enzalutamide. First generation androgen receptor inhibitor therapy (e.g., bicalutamide) is allowed and is not considered to be prior ARPi therapy. It must be discontinued > 6 weeks prior to start of treatment.
5. Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status
6. Fasting glucose </= 100 mg/dL and HbA1c < 5.7%

Exclusion criteria 6

1. Presence of liver metastasis
2. 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
3. Type 1 or Type 2 diabetes mellitus
4. Other concurrent anti-cancer therapy
5. 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
6. Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Radiographic Progression-Free Survival (rPFS)

Secondary endpoints 9

1. Confirmed Composite Response Rate (RR)
2. Confirmed prostate-specific antigen 90 (PSA90)
3. Confirmed prostate-specific antigen 50 (PSA50)
4. Objective Response Rate (ORR)
5. Duration of Response (DOR)
6. Overall Survival (OS)
7. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
8. Change from baseline in selected vital signs
9. Change from baseline in selected clinical laboratory test results

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 4

Locations

4 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 47 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications