RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well inavolisib plus enzalutamide works and how safe it is compared with a doctor's choice of another hormone-blocking drug or docetaxel. It is for people whose prostate cancer has spread and keeps growing despite treatment to lower testosterone. Participants must have had one newer hormone-blocking drug and be selected based on certain tumor markers.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue or cell test shows prostate adenocarcinoma, a type of prostate cancer, without small-cell or neuroendocrine features.
  • Cancer has spread and is getting worse despite treatment to lower testosterone. This must be shown by rising PSA blood tests or scans.
  • Have taken exactly one newer hormone-blocking drug for at least 12 weeks: abiraterone, apalutamide, enzalutamide, or darolutamide.
  • Have a tumor tissue sample of enough quality and size to test for tumor markers.
  • Are fully active or can do light work, with limits only on hard physical activity.
  • Have fasting blood sugar below 126 mg/dL and HbA1c, a measure of average blood sugar, below 6%.

Who can't join

  • Cancer has spread to the liver.
  • Have used drugs that block the PI3K, AKT, or mTOR pathway, signals that help cells grow.
  • Have type 1 or type 2 diabetes.
  • Have had cell-killing chemotherapy or certain newer hormone treatments for cancer that spread and resisted testosterone-lowering treatment. Earlier docetaxel may be allowed if cancer did not worsen during treatment or for 6 months afterward for hormone-sensitive cancer, or 12 months afterward when given before or after surgery.
  • Some other past treatments are allowed only after a waiting period: more than 28 days for sipuleucel-T, more than 14 days for a PARP inhibitor used under local prescribing rules, or more than 8 weeks for one radiation-based drug treatment.
  • Are getting other cancer treatment, except treatment to lower testosterone.
  • Recently took certain drugs that strongly or moderately affect the liver proteins CYP2C8 or CYP3A4. The required wait is at least 1 week or five drug half-lives, whichever is longer; a half-life is the time for half a drug to leave the body.
  • Had a blood product transfusion within 28 days of joining, or had one only to meet the study's entry rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (6)

CA

IA

NY

RI

SC