Update: FDA approves Truqap for some people with metastatic prostate cancer
The Food and Drug Administration (FDA) approved Truqap (capivasertib) with abiraterone and prednisone for adults with metastatic prostate cancer that still responds to hormone-lowering treatment but is missing a protein called PTEN. This approval provides a new targeted treatment option for some patients based on tumor testing results. (posted 10/8/2026)
By: Piri Welcsh, PhD
Reviewed by: Alan Bryce, MD
RELEVANCE
Most relevant for: People with metastatic castration sensitive prostate cancer (mCSPC).
It may also be relevant for:
- people with prostate cancer
- people with castration-sensitive prostate cancer
- people with metastatic or advanced cancer
Relevance: Medium-High
Research Timeline: Human Research
What is this study about?
The approved Truqap (capivasertib) with and prednisone for adult prostate cancer that has spread beyond the but still responds to hormone treatment. Formerly known as hormone-sensitive cancer (mHSPC), this condition is now called androgen pathway modulation-naïve or -sensitive (mAPMN/S) cancer.
This approval is only for people whose tumors have lost the protein, which helps control cell growth. When cancer cells lose , cancer can grow more aggressively.
The also approved the Ventana (SP218) RxDx Assay as a companion to identify people whose tumors lack the protein and may benefit from this treatment.
Eligibility for this treatment specifically requires loss of protein in the tumor. People with an in the gene (individuals with hamartoma tumor syndrome or ) who develop prostate cancer must undergo tumor testing to determine whether they might benefit from Truqap.
Why is this study important?
Some prostate cancers have mutations that help them grow, even when standard hormone treatments are used. These changes can lead to loss of function. cancers with loss tend to be more aggressive and may progress sooner than other cancers.
What is Truqap?
Truqap is a that blocks chemical signals that tell cancer cells to multiply. In tumors that have lost , Truqap helps reverse some of the signals that drive cancer cells to grow and divide. Adding Truqap to and prednisone creates a powerful combination treatment that blocks multiple cell growth pathways at the same time.
In 2023, the approved Truqap for the treatment of adults with metastatic breast cancer. This approval is specifically for people with an AKT1, PIK3 or mutation and whose cancer has recurred or worsened after standard hormone therapy. You can read more about the approval in our XRAY review here.
Study findings
The approval was based on the CAPItello-281 study. This was a large phase 3 study of 1,012 adults with newly diagnosed prostate cancer that lost function but still responded to hormone treatment.
Participants were randomly assigned to receive either Truqap with or a with . Both groups also received prednisone or prednisolone and standard hormone-lowering therapy.
The study measured radiographic progression-free survival, the length of time before scans showed that cancer had grown or spread.
People who received Truqap with had an average of 33 months before their cancer showed new growth or spreading on scans. For those who took a with , that time was about 26 months. Adding Truqap to the treatment delayed cancer growth on scans an average of 7 months.
At the time of the analysis, it was too early to know whether people who received Truqap lived longer.
Possible side effects
The prescribing information includes warnings about high blood sugar, diarrhea, skin reactions and harm to a developing fetus. Males taking Truqap with female partners of reproductive age are advised to use effective contraception during treatment with TRUQAP and for 4 months after the last dose.
In the CAPItello-281 study, serious or severe side effects were more common in people who received Truqap. The most common severe side effects included:
- rash
- high blood sugar
People taking Truqap may need more regular blood sugar monitoring and support managing diarrhea or skin symptoms.
What does this mean for me?
If you have prostate cancer that still responds to hormone treatment, ask your doctor whether your tumor has been tested for loss. If your cancer has loss, Truqap with and prednisone may be a treatment option.
This treatment may help delay cancer growth seen on scans, but it can also cause side effects that require monitoring and treatment.
This approval does not apply to everyone with cancer. People with cancer without loss or cancer that no longer responds to hormone treatment may need different treatment options.
References
U.S. Food and Drug Administration. approves capivasertib with and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive cancer. Published June 12, 2026. Accessed July 16, 2026.
Fizazi K, Clarke NW, De Santis M, et al. Capivasertib plus in PTEN-deficient hormone-sensitive cancer: CAPItello-281 phase III study. Annals of Oncology. 2026;37(1):53-68.
Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
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posted 10/8/2026
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