FDA Approves Capivasertib for PTEN-Deficient Metastatic Prostate Cancer

A brake that some tumors have lost

PTEN is a tumor suppressor gene. Its job is to damp down a growth signaling pathway called PI3K/AKT. When PTEN is missing or broken, that pathway runs unchecked and the cell keeps getting told to grow and survive.

Capivasertib, sold as Truqap, blocks AKT, the kinase sitting at the center of that pathway. The drug is only expected to help where the brake is already gone, which is why the approval names the biomarker rather than the cancer alone.

What FDA approved, exactly

On 12 June 2026 the FDA approved capivasertib with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naive or -sensitive prostate cancer that is PTEN-deficient.

Two parts of that sentence do real work.

"Androgen pathway modulation-naive or -sensitive", abbreviated mAPMN/S, is the newer name for what used to be called metastatic hormone-sensitive prostate cancer. It means the cancer still responds to treatment that lowers or blocks male hormones. Our page on hormone therapy for prostate cancer explains that setting.

"PTEN-deficient as detected by an FDA-authorized test" means a laboratory result is required first. FDA approved the VENTANA PTEN (SP218) RxDx Assay alongside the drug as the companion diagnostic. In the trial, PTEN deficiency was defined precisely: at least 90% of viable cancer cells showing no specific staining in the cytoplasm.

Without that result, the approval does not apply. Our page on biomarker testing covers how these tests are ordered and read.

The trial

CAPItello-281, registered as NCT04305496, was randomized, double-blind and placebo-controlled. It enrolled 1,012 adults with newly diagnosed, PTEN-deficient metastatic disease.

Everyone received abiraterone with prednisone or prednisolone. Half also received capivasertib; half received placebo. PTEN status was determined in advance by central testing.

The main measure was investigator-assessed radiographic progression-free survival, meaning time until scans showed the cancer growing. Median radiographic progression-free survival was 33.2 months with capivasertib and 25.7 months with placebo. The hazard ratio was 0.81, with a two-sided p-value of 0.034.

Overall survival was a secondary measure, and FDA states the results were immature when the main analysis was done. That means not enough deaths had occurred to draw a conclusion, so whether people live longer is not yet answered.

The medians are 7.5 months apart. The hazard ratio's confidence interval runs from 0.66 to 0.98, so the true size of the benefit is uncertain, and the upper end sits close to 1, which would mean no difference.

How it is taken, and what it costs the body

The FDA notice describes capivasertib as taken by mouth twice a day for four days, followed by three days off, until the disease progresses or side effects become unacceptable, together with abiraterone and prednisone. The notice also says patients should receive a GnRH analog at the same time or have had both testicles removed. The prescribing team sets the actual dose and schedule; this page does not.

Blocking AKT everywhere in the body, not just in tumors, produces predictable trouble.

The label carries four warnings.

Hyperglycemia. Capivasertib can cause severe high blood sugar, including diabetic ketoacidosis, with fatal outcomes reported. Blood glucose and hemoglobin A1C are checked before starting and at regular intervals afterwards. This is the most important one, because AKT sits in the insulin signaling pathway and blocking it interferes with glucose control by design. Call the care team right away about signs of very high blood sugar, and call 911 or go to an emergency room if you feel very ill or confused.

Diarrhea. The label states it occurred in most patients and can be severe, with dehydration. It tells prescribers to advise patients to increase oral fluids, start antidiarrheal treatment, and consult a healthcare provider. Call the care team the same day for diarrhea, and call 911 or go to an emergency room for fainting or confusion.

Skin reactions. Monitored, with the drug held, reduced or stopped depending on severity.

Harm to a fetus. Effective contraception is advised.

When to get checked

This approval is for advanced disease. Most prostate cancer is found earlier. NCI lists these as reasons to see a doctor:

• Trouble starting the flow of urine.
• Frequent urination, especially at night.
• Trouble emptying the bladder completely.
• A weak or stop-and-go flow of urine.

In advanced disease NCI adds pain in the back, hips or pelvis that does not go away. It also adds symptoms of anemia such as breathlessness, severe tiredness, a fast heartbeat, dizziness or pale skin.

An important caveat from NCI: as men age the prostate often enlarges and presses on the urethra, a condition called benign prostatic hyperplasia. It is not cancer, and NCI notes its symptoms can look like those of prostate cancer. That is why a test rather than a symptom decides the question. Our page on prostate cancer covers the PSA blood test and biopsy.

The wider numbers

The American Cancer Society projects about 333,830 new prostate cancers in the United States in 2026, more than any other cancer, and about 36,320 deaths; SEER republishes both estimates. Five-year relative survival for 2016 to 2022 was 98.2%, and the median age at diagnosis is 68.

Stage explains why the overall figure is so high. In the same 2016–2022 cohort, five-year relative survival is 100.0% for localized disease and 100.0% for regional spread, which together account for 83% of diagnoses. For distant disease, 9% of cases, it is 40.1%. That distant group is the population this approval addresses.

About 13.2% of men are diagnosed with prostate cancer at some point in life. These are population figures from past years and describe no individual.

What this does not mean

It does not mean the drug helps prostate cancer generally. Without PTEN deficiency on an authorized test, the approval does not apply.

It does not mean people live longer. Overall survival data were immature, and that question remains open.

It does not mean an easy addition to treatment. Severe hyperglycemia, frequent diarrhea and skin reactions all require monitoring and can force the dose down or stop it.

And a median is a midpoint. Half the men in each arm did better than the figure quoted and half did worse, which is why no individual should read 33.2 months as a personal forecast.

Sources

• FDA, FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naive or -sensitive prostate cancer — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation
• DailyMed, TRUQAP (capivasertib) tablets prescribing information — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d698c106-2322-401e-b738-cbd83c843ecf
• NCI PDQ, Prostate Cancer Treatment (Patient Version) — https://www.cancer.gov/types/prostate/patient/prostate-treatment-pdq
• SEER Cancer Stat Facts, Prostate Cancer — https://seer.cancer.gov/statfacts/html/prost.html

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.

See an error, old source, or unclear wording? Tell us.