PTEN-deficient mAPMN/S is an aggressive form of prostate cancer
with an especially poor prognosis2,3
PRIMARY ANALYSIS (DCO October 2024)1,4
~8
MONTH
IMPROVEMENT IN MEDIAN rPFS with TRUQAP + abi/pred
vs placebo + abi/pred1
33.2
months
rPFS with TRUQAP
+ abi/pred (n=507)
(95% CI:
25.8–44.2)
25.7
months
rPFS with placebo
+ abi/pred
(n=505)
(95% CI:
22.0–29.9)
HR=0.81 (95% CI: 0.66–0.98; P=0.034)
ADDITIONAL FOLLOW-UP DATA (DCO March 2026)5
These updated rPFS data are from an ad hoc descriptive analysis conducted at a March 2026 data cutoff and were not formally tested for statistical significance. rPFS in the primary analysis was statistically significant.
35.5
months
m-rPFS with TRUQAP
+ abi/pred (n=507)
(95% CI:
29.7–40.5)
26.0
months
m-rPFS with placebo
+ abi/pred
(n=505)
(95% CI:
22.4–31.3)
HR=0.83 (95% CI: 0.70–0.99)
Testing
Why and how to use IHC to test for PTEN deficiency in mAPMN/S prostate cancer
NCCN
CATEGORY 1 PREFERRED
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer recommends capivasertib (TRUQAP®) + fulvestrant as a Category 1 Preferred treatment option for HR+/HER2- aBC or mBC with at least one or more PIK3CA or AKT1 activating mutations or PTEN alterations following progression after one or more prior lines of ET, including one line containing a CDK4/6i3
abi=abiraterone; DCO=data cutoff; HR=hazard ratio; IHC=immunohistochemistry; mAPMN/S=metastatic androgen pathway modulation-naïve or -sensitive; mHSPC=metastatic hormone-sensitive prostate cancer; m-rPFS=median radiographic progression-free survival; pred=prednisone; PTEN=phosphatase and tensin homolog; rPFS=radiographic progression-free survival.
References: 1. TRUQAP® (capivasertib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 2. Zhang JY, Kong YY, Wang QF, et al. Prognostic value of PTEN in de novo diagnosed metastatic prostate cancer. Asian J Androl. 2022;24(1):50-55. doi:10.4103/aja.aja_39_21 3. Jamaspishvili T, Berman DM, Ross AE, et al. Clinical implications of PTEN loss in prostate cancer. Nat Rev Urol. 2018;15(4):222-234. doi:10.1038/nrurol.2018.9 4. Fizazi K, Clarke NW, De Santis M, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68. doi:10.1016/j.annonc.2025.10.004 [including the Supplementary Appendix] 5. Fizazi K, Clarke NW, De Santis M, et al. Capivasertib plus abiraterone in PTEN-deficient de novo metastatic hormone-sensitive prostate cancer: updated survival analysis from CAPItello-281 [in press, pre-proof; posted online October 23, 2026]. Ann Oncol. 2026. doi:10.1016/j.annonc.2026.10.097 6. Armstrong AJ, Morris MJ, Abida W, et al. Trial design and objectives for patients with prostate cancer: recommendations from the Prostate Cancer Working Group 4. J Clin Oncol. 2026;44(13):1249-1265. doi:10.1200/JCO-25-02834
See Full Indications
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets
TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components.
Hyperglycemia
TRUQAP can cause severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
The safety of TRUQAP has not been established in patients with Type 1 diabetes or Type 2 diabetes that is uncontrolled or requiring insulin at baseline as these patients were excluded from clinical studies. Before initiating treatment with TRUQAP, test fasting glucose levels (FPG or FBG), HbA1C levels, and optimize fasting glucose. After initiating treatment with TRUQAP, monitor or self-monitor FG levels on Day 3 or 4 of the dosing week during weeks 1, 2, 4, 6, and 8; then monthly while on treatment with TRUQAP; and as clinically indicated. Monitor HbA1C levels every 3 months during treatment with TRUQAP and as clinically indicated. Patients with a history of well-controlled Type 2 diabetes mellitus may require intensified anti-hyperglycemic treatment and close monitoring of FG levels.
For patients who experience hyperglycemia during treatment with TRUQAP, monitor FG at least twice weekly, on days on and off TRUQAP, until FG decreases to baseline levels. During treatment with anti-diabetic medications, monitor FG at least once a week for 2 months, followed by once every 2 weeks, or as clinically indicated. Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia and initiation of FG monitoring at home for patients who have risk factors for hyperglycemia or who experience hyperglycemia. Advise patients on the signs and symptoms of hyperglycemia and counsel patients on lifestyle changes.
Withhold TRUQAP immediately when ketoacidosis is suspected. If ketoacidosis is confirmed, permanently discontinue TRUQAP. Withhold TRUQAP in clinical situations known to increase the risk of severe hyperglycemia or ketoacidosis (eg, suspected serious infection or acute illness). Based on the severity of hyperglycemia, withhold, reduce dose, or permanently discontinue TRUQAP.
Diarrhea
TRUQAP can cause severe diarrhea associated with dehydration
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start anti-diarrheal treatment at the first sign of diarrhea while taking TRUQAP. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.
Cutaneous Adverse Reactions
TRUQAP can cause cutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia (PPE), and drug reaction with eosinophilia and systemic symptoms (DRESS).
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
Monitor patients for signs and symptoms of cutaneous adverse reactions. Early consultation with a dermatologist is recommended. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.
Embryo-Fetal Toxicity
Based on findings from animals and mechanism of action, TRUQAP can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRUQAP and for 1 month after the last dose.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRUQAP and for 4 months after the last dose.
TRUQAP is used in combination with fulvestrant or abiraterone. Refer to the full Prescribing Information of fulvestrant or abiraterone for pregnancy and contraception information.
ADVERSE REACTIONS
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid concomitant use with a strong CYP3A inhibitor. If concomitant use cannot be avoided, reduce the dose of TRUQAP and monitor patients for adverse reactions.
Moderate CYP3A Inhibitors: When concomitantly used with a moderate CYP3A inhibitor, reduce the dose of TRUQAP and monitor patients for adverse reactions.
Strong or Moderate CYP3A Inducers: Avoid concomitant use of TRUQAP with strong or moderate CYP3A inducers.
INDICATIONS AND USAGE
Please see full Prescribing Information, including Patient Information for TRUQAP.
You may report side effects related to AstraZeneca products
.
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets
IMPORTANT SAFETY INFORMATION ABOUT TRUQAP® (capivasertib) tablets
TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components.
Hyperglycemia
TRUQAP can cause severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
The safety of TRUQAP has not been established in patients with Type 1 diabetes or Type 2 diabetes that is uncontrolled or requiring insulin at baseline as these patients were excluded from clinical studies. Before initiating treatment with TRUQAP, test fasting glucose levels (FPG or FBG), HbA1C levels, and optimize fasting glucose. After initiating treatment with TRUQAP, monitor or self-monitor FG levels on Day 3 or 4 of the dosing week during weeks 1, 2, 4, 6, and 8; then monthly while on treatment with TRUQAP; and as clinically indicated. Monitor HbA1C levels every 3 months during treatment with TRUQAP and as clinically indicated. Patients with a history of well-controlled Type 2 diabetes mellitus may require intensified anti-hyperglycemic treatment and close monitoring of FG levels.
For patients who experience hyperglycemia during treatment with TRUQAP, monitor FG at least twice weekly, on days on and off TRUQAP, until FG decreases to baseline levels. During treatment with anti-diabetic medications, monitor FG at least once a week for 2 months, followed by once every 2 weeks, or as clinically indicated. Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia and initiation of FG monitoring at home for patients who have risk factors for hyperglycemia or who experience hyperglycemia. Advise patients on the signs and symptoms of hyperglycemia and counsel patients on lifestyle changes.
Withhold TRUQAP immediately when ketoacidosis is suspected. If ketoacidosis is confirmed, permanently discontinue TRUQAP. Withhold TRUQAP in clinical situations known to increase the risk of severe hyperglycemia or ketoacidosis (eg, suspected serious infection or acute illness). Based on the severity of hyperglycemia, withhold, reduce dose, or permanently discontinue TRUQAP.
Diarrhea
TRUQAP can cause severe diarrhea associated with dehydration
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start anti-diarrheal treatment at the first sign of diarrhea while taking TRUQAP. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.
Cutaneous Adverse Reactions
TRUQAP can cause cutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia (PPE), and drug reaction with eosinophilia and systemic symptoms (DRESS).
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
Monitor patients for signs and symptoms of cutaneous adverse reactions. Early consultation with a dermatologist is recommended. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.
Embryo-Fetal Toxicity
Based on findings from animals and mechanism of action, TRUQAP can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRUQAP and for 1 month after the last dose.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRUQAP and for 4 months after the last dose.
TRUQAP is used in combination with fulvestrant or abiraterone. Refer to the full Prescribing Information of fulvestrant or abiraterone for pregnancy and contraception information.
ADVERSE REACTIONS
Metastatic HR-Positive, HER2-Negative Breast Cancer
PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid concomitant use with a strong CYP3A inhibitor. If concomitant use cannot be avoided, reduce the dose of TRUQAP and monitor patients for adverse reactions.
Moderate CYP3A Inhibitors: When concomitantly used with a moderate CYP3A inhibitor, reduce the dose of TRUQAP and monitor patients for adverse reactions.
Strong or Moderate CYP3A Inducers: Avoid concomitant use of TRUQAP with strong or moderate CYP3A inducers.
INDICATIONS AND USAGE
Please see full Prescribing Information, including Patient Information for TRUQAP.
You may report side effects related to AstraZeneca products.
