Study on Inavolisib Treatment for Metastatic Castration-Resistant Prostate Cancer
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT07287150
This clinical trial is testing a new treatment combining inavolisib with enzalutamide for men with metastatic castration-resistant prostate cancer (mCRPC) who have already tried one other advanced hormone therapy. The study will compare this new combination to other standard treatments chosen by doctors.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate how effective and safe the combination of inavolisib and enzalutamide is for treating men with metastatic castration-resistant prostate cancer (mCRPC). Participants in the study will have already tried one other advanced hormone therapy. The study will compare this new treatment to other standard options, such as different hormone therapies or chemotherapy, to see which works better.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer that has spread and is resistant to standard hormone therapy.
- Cancer must be progressing, shown by rising PSA levels, new soft tissue tumors, or new bone lesions.
- Previously treated with one advanced hormone therapy like abiraterone or enzalutamide.
- Must provide a tumor sample for testing.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have normal fasting blood sugar and HbA1c levels.
Exclusion Criteria
- Cancer has spread to the liver.
- Previously treated with drugs targeting the PI3K/AKT/mTOR pathway.
- Have Type 1 or Type 2 diabetes.
- Previously treated with chemotherapy or certain new hormonal treatments for mCRPC, except for specific allowed treatments like prior docetaxel under certain conditions.
- Currently receiving other cancer treatments, except for hormone therapy.
- Taking certain medications that affect liver enzymes within a week before starting the study.
- Recent blood transfusions solely to qualify for the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCSF | 94115 | San Francisco | California |
| Holden Comprehensive Cancer Center | 52242-1009 | Iowa City | Iowa |
| Montefiore Einstein Cancer Center | 10461 | The Bronx | New York |
| Carolina Urologic Research Center | 29572-4607 | Myrtle Beach | South Carolina |
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