The FDA has approved capivasertib (Truqap) in combination with abiraterone and prednisone for adults with metastatic prostate cancer whose tumors are deficient in a tumor suppressor protein called PTEN. The approval marks the first targeted therapy specifically approved for this group of patients, offering a more personalized approach to treatment.
Why This Approval Matters
Prostate cancer is one of the most common cancers diagnosed in men. While many patients respond well to hormone-based treatments, some tumors have genetic changes that make them more aggressive.
One of these alterations involves PTEN, a gene that normally helps control cell growth. When PTEN function is lost, cancer cells can activate a signaling pathway known as PI3K/AKT, allowing tumors to grow and spread more easily. Researchers estimate that approximately one in four patients with metastatic hormone-sensitive prostate cancer may have PTEN-deficient disease, which is often associated with poorer outcomes.
Capivasertib is designed to block AKT, a key protein within this pathway. By targeting a known driver of tumor growth, the drug aims to slow disease progression in patients whose cancers rely on this signaling network.
Clinical Trial Results
The FDA approval was based on results from the Phase 3 CAPItello-281 clinical trial, which enrolled 1,012 patients with newly diagnosed metastatic PTEN-deficient prostate cancer. Participants were randomly assigned to receive either capivasertib plus standard treatment with abiraterone and androgen-deprivation therapy or a placebo plus standard treatment.
The study’s primary endpoint was radiographic progression-free survival, a measure of how long patients lived before scans showed their cancer had worsened.
Researchers found that patients receiving capivasertib experienced a median progression-free survival of 33.2 months, compared with 25.7 months for those receiving standard treatment alone. This translated to a 19% reduction in the risk of disease progression or death during the study period.
While overall survival data are not yet mature enough for definitive conclusions, early results numerically favored the capivasertib-containing regimen. Investigators will continue following patients to better understand the treatment’s long-term impact on survival.
What Patients Should Know About Testing
Not every patient with metastatic prostate cancer will be eligible for this treatment.
The FDA simultaneously approved a companion diagnostic test that identifies PTEN-deficient tumors. Patients must have a confirmed PTEN deficiency detected by an FDA-authorized test before receiving capivasertib.
This approval highlights the growing importance of biomarker testing in prostate cancer care. By identifying the genetic characteristics of an individual’s tumor, physicians can better match patients with therapies that are most likely to benefit them.
Safety Considerations
As with any cancer treatment, capivasertib can cause side effects. The FDA label includes warnings for high blood sugar levels (hyperglycemia), diarrhea, skin reactions, and embryo-fetal toxicity. In the CAPItello-281 study, rash and hyperglycemia were among the most commonly reported severe side effects. Patients receiving treatment may require monitoring and supportive care to manage these adverse events.
Patients should discuss potential risks and benefits with their oncology team to determine whether this treatment is appropriate for them.
Looking Ahead
The approval of capivasertib represents another step toward precision medicine in prostate cancer, where treatment decisions are increasingly guided by the biology of a patient’s tumor rather than disease stage alone.
As researchers continue to investigate targeted therapies and biomarker-driven treatment strategies, approvals like this may help expand options for patients whose cancers have historically been associated with worse outcomes. Ongoing follow-up from the CAPItello-281 trial will provide additional information about whether the treatment can also improve overall survival in the years ahead.
References
U.S. Food and Drug Administration. FDA Approves Capivasertib with Abiraterone and Prednisone for PTEN-Deficient Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer. June 12, 2026. Accessed June 15, 2026. Available at: FDA announcement
