ClinicaliQ Trial Snapshot
- A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer — Recruiting • Phase II • Oncology • NCT07287150.
- What is being tested: Inavolisib (a PI3K inhibitor) combined with enzalutamide versus standard physician-selected alternatives (other androgen receptor pathway inhibitors or docetaxel) in biomarker-selected patients with metastatic castration-resistant prostate cancer.
- Patient eligibility overview: Men with mCRPC who are biomarker-selected (likely PI3K pathway-altered) and have received prior androgen deprivation therapy; specific prior treatment history determines eligibility for comparison arms.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.