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New treatment option for Metastatic Castration-Resistant Prostate Cancer
Official title A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07287150
What this study is testing
What is Inavolisib?
Inavolisib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for hormone-...
- 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
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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...
- 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%
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Iowa City, Iowa, United States
- The Bronx, New York, United States
- Providence, Rhode Island, United States
- Myrtle Beach, South Carolina, United States
- St Leonards, New South Wales, Australia
- Birtinya, Queensland, Australia
- Herston, Queensland, Australia
- Box Hill, Victoria, Australia
- Porto Alegre, Rio Grande do Sul, Brazil
- Santo André, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Bordeaux, Gironde, France
- Lyon, France
- Marseille, France
- Hamburg, Germany
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Iowa City, Iowa, United States; The Bronx, New York, United States; Providence, Rhode Island, United States; Myrtle Beach, South Carolina, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.