Hormone-Sensitive Prostate CancerPhase 3CAPItello-281NCT04493853
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
A Phase 3 study testing Capivasertib and Abiraterone Acetate in people with Hormone-Sensitive Prostate Cancer, run by AstraZeneca at 323 sites in 32 countries.
Trial summary
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. Read more about this study
- Who is it for?
- Ages 18 to 130 years, men only
- Conditions the study is for
- Hormone-Sensitive Prostate Cancer
- What is being tested?
- Capivasertib and Abiraterone Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,012 participants
- Where
- 323 sitesin 32 countries
- Study dates
- 13 Jul 2020to 31 Mar 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asymptomatic or mildly symptomatic, histologically-confirmed de novo hormone-sensitive prostate adenocarcinoma without small-cell tumours diagnosed within 180 days of randomisation
- Consent to provide a FFPE tissue block (preferred) or slides. Tissue from bone metastases is not acceptable
- A valid PTEN IHC result indicating PTEN deficiency (centralized testing)
- Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion accurately assessed at baseline and suitable for repeated assessment with CT and/or MRI. PSMA PET identification only will not be eligible
- Candidate for abiraterone and steroid therapy
- Ongoing ADT with GnRH analogue, or LHRH agonists or antagonist, or bilateral orchiectomy (regardless of method) is from 0 days to a max. of 93 days prior to randomisation
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- Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- Able and willing to swallow and retain oral medication
- 7-day Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory(BFI) questionnaires and the analgesic diary during screening completed. Participants must complete a minimum of 4 successful assessments within a 7-day period prior to randomisation.
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- Capable of giving signed informed consent
- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples
Who cannot join
- Prior radical prostatectomy or definitive radiotherapy with therapeutic intent for prostate cancer. Palliative radiotherapy is allowed providing any wide field radiation therapy is completed more than 4 weeks before the start of study treatment
- Major surgery (excluding placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of study treatment
- Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 msec obtained from triplicate ECGs ii. History of QT prolongation associated with other medications that required discontinuation of that medication.
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- Family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
- Medical history significant for arrhythmia which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
- Any clinically important abnormalities in conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) vi. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, or any concomitant medication known to significantly prolong the QT interval vii. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, angioplasty, myocardial infarction, angina pectoris.
- Congestive heart failure NYHA Grade ≥ 2 ix. Symptomatic hypotension - systolic blood pressure (SBP) <90 mmHg and/or diastolic blood pressure (DBP) <50 mmHg x. Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 95 mmHg).
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment ii. HbA1c ≥8.0% (63.9 mmol/mol)
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Absolute neutrophil count < 1.5x 10^9/L ii. Platelet count < 100x 10^9/L iii. Haemoglobin < 9 g/dL (< 5.59 mmol/L) iv. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases. Elevated alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigator's judgement v. Total bilirubin > 1.5x ULN (participants with confirmed Gilbert's syndrome may be included in the study with a higher value) vi. Creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation)
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or known active infection including hepatitis B, hepatitis C, and HIV
- unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria: i. a "superscan" of bone scan, and ii. no soft tissue lesion that can be assessed by RECIST criteria
- Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent
- Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent
- Previous allogeneic bone marrow transplant or solid organ transplant
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
- Treatment with any of the following:
- Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment ii. Any investigational agents or study drugs from a previous clinical study within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment iii. Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long half-life (eg, biologics) iv. Strong inhibitors or strong inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John's wort). Note that adequate washout or dose reduction may be required for some CYP3A substrates prior to initiating Capivasertib dosing.
- Drugs known to significantly prolong the QT interval and associated with Torsades de Pointes within 5 half-lives of the first dose of study treatment
- Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives, whichever is longer.
- History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone.
Trial locations and contacts
323 sites in 32 countries.
323 sites in 32 countries
China37 sites
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Beijing, 100034
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Beijing, 100036
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Beijing, 100050
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Beijing, CN-100730
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Changchun, 130021
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Changsha, 410003
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Changsha, 410008
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Chengdu, 610000
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Chengdu, 610072
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Chongqing, 400030
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Chongqing, 400038
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Fuzhou, 350001
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Fuzhou, 350005
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Guangzhou, 510060
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Guangzhou, 510180
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Guangzhou, 510515
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Guiyang, 550002
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Hangzhou, 310003
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Hangzhou, 310014
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Hangzhou, 310052
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Kunming, 650118
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Nanchang, 330006
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Nanjing, 2100008
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Nanjing, 210009
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Nantong, 226361
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Ningbo, 315000
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Shanghai, 200032
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Shanghai, 200080
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Shanghai, 200127
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Shengyang, 110004
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Tianjin, 300211
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Wenzhou, CN-325000
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Wuhan, 430030
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Xi'an, 710061
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Yantai, 264000
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Zhengzhou, 450000
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Zhengzhou, 450008
Japan35 sites
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Bunkyō City, 113-8431
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Chiba, 260-8677
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Chūōku, 260-8717
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Fukuoka, 812-8582
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Hamamatsu, 431-3192
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Hirakata-shi, 573-1191
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Hirosaki-shi, 036-8563
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Isehara-shi, 259-1193
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Kanazawa, 920-8641
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Kashihara-shi, 634-8522
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Kawagoe-shi, 350-8550
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Kisarazu-shi, 292-8535
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Kita-gun, 761-0793
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Kobe, 650-0047
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Kumamoto, 860-0008
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Kyoto, 606-8507
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Miyazaki, 889-1692
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Morioka, 028-3695
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Nagano, 381-8551
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Nagasaki, 852-8501
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Nagoya, 466-8560
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Nagoya, 466-8650
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Natori-shi, 981-1293
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Osaka, 541-8567
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Osakasayama-shi, 589-8511
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Ota Shi, 373-8550
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Sagamihara-shi, 252-0375
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Sapporo, 060-8648
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Shinjuku-ku, 160-8582
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Toon-shi, 791-0295
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Tsu, 514-8507
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Ube-shi, 755-8505
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Yokohama, 232-0024
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Yokosuka-shi, 238-8558
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Yufu-shi, 879-5593
United States33 sites
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Asheville, North Carolina, 28805
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Baltimore, Maryland, 21201
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Charleston, South Carolina, 29401
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Chattanooga, Tennessee, 37404
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Chicago, Illinois, 60637
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Columbus, Ohio, 43210
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Denver, Colorado, 80211
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Detroit, Michigan, 48201
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Durham, North Carolina, 27710
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Fort Myers, Florida, 33901-8101
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Geneva, Illinois, 60134
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Grand Rapids, Michigan, 49503
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Houston, Texas, 77090
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La Jolla, California, 92037
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Lakewood, Colorado, 80215
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Lancaster, Pennsylvania, 17601
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Lisle, Illinois, 60532
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Madison, Wisconsin, 53792
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Myrtle Beach, South Carolina, 29572
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Norfolk, Virginia, 23502
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Norwich, Connecticut, 06360
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Orange, California, 92868
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Philadelphia, Pennsylvania, 19111
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Pittsburgh, Pennsylvania, 15232
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Roanoke, Virginia, 24014
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San Diego, California, 92123
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Seattle, Washington, 98104
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Syracuse, New York, 13210
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The Bronx, New York, 10461
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Troy, Michigan, 48084
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Tucson, Arizona, 85723
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Tucson, Arizona, 85741
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West Palm Beach, Florida, 33401
India16 sites
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Ahmedabad, 380060
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Bangalore, 560022
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Bangalore, 560027
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Delhi, 110085
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Faridabad, 121001
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Kanpur, 208005
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Kolkata, 700160
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Madurai, 625107
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Manipal, 576104
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Meerut, 250001
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Mohali, 160055
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Nagpur, 440001
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New Delhi, 110005
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New Delhi, 11029
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Thiruvananthapuram, 695 011
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Varanasi, 221005
Brazil15 sites
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Belém, 66073-005
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Belo Horizonte, 30110-022
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Florianópolis, 88020-210
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Fortaleza, 60135-237
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Jaú, 17210-120
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Joinville, 89201-260
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Porto Alegre, 90035-000
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Porto Alegre, 90050-170
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Porto Alegre, 90160-093
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Ribeirão Preto, 14051-140
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Rio de Janeiro, 20230-130
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Santa Maria, 97015-450
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São José do Rio Preto, 15090-000
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São Paulo, 01327-001
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Três Lagoas, 79601-001
France12 sites
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Besançon, 25030
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Bordeaux, 33076
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Marseille, 13273
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Montpellier, 34298
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Nice, 06100
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Paris, 75674
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Pierre-Bénite, 69495
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Quimper, 29107
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Rennes, 35033
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Strasbourg, 67098
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Suresnes, 92151
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Villejuif, 94805
Argentina10 sites
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Berazategui, B1884BBF
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Buenos Aires, 1426
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CABA, 1425
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CABA, C1012AAR
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Ciudad de Buenos Aires, C1120AAT
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Ciudad de Buenos Aires, C1280AEB
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La Plata, 1900
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Mendoza, 5500
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Rosario, S2000DEJ
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San Salvador de Jujuy, 4600
Poland10 sites
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Bydgoszcz, 85-796
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Gdansk, 80-214
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Koszalin, 75-581
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Lodz, 90-242
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Olsztyn, 10-228
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Poznan, 61-731
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Rzeszów, 35-055
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Torun, 87-100
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Warsaw, 02-781
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Warsaw, 04-073
Spain10 sites
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Badalona (Barcelona), 08916
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Barcelona, 08041
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Las Palmas de Gran Canaria, 35016
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Madrid, 28007
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Madrid, 28034
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Madrid, 28040
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Madrid, 28041
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Oviedo, 33011
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Santander, 39008
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Seville, 41009
Canada9 sites
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Brampton, Ontario, L6R 3J7
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Calgary, Alberta, T2N 5G2
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Edmonton, Alberta, T6G 1Z2
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Kelowna, British Columbia, V1Y 5L3
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Montreal, H3T 1E2
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Oshawa, Ontario, L1G 2B9
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Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5G 2M9
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Vancouver, British Columbia, V5Z 1H7
Germany9 sites
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Berlin, 10117
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Duisburg, 47169
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Hamburg, 20246
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Herne, 44625
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Mettmann, 40822
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Münster, 48149
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Nuremberg, 90419
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Nürtingen, 72622
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Wesel, 46483
Bulgaria8 sites
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Pleven, 5804
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Plovdiv, 4004
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Plovdiv, 4109
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Sofia, 1407
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Sofia, 1527
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Sofia, 1756
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Sofia, 1797
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Varna, 9000
Russia8 sites
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Moscow, 105077
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Moscow, 117997
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Moscow, 121205
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Novisibirsk, 630082
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Novosibirsk, 630007
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Saint Petersburg, 190103
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Saint Petersburg, 191014
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Yaroslavl, 150054
South Korea8 sites
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Daegu, 41404
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Goyang-si, 10408
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Seongnam-si, 13620
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06351
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Seoul, 06591
Taiwan8 sites
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Kaohsiung City, 807
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Kaohsiung City, 81362
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Taichung, 404
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Taichung, 43503
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Tainan, 710
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Taipei, 112
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Taipei, 11490
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Taoyuan City, 333
Turkey (Türkiye)8 sites
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Ankara, 06010
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Ankara
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Antalya, 07059
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Eskişehir, 26040
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Istanbul, 34098
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Izmir, 35100
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Izmir, 35575
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Kayseri, 38039
Peru7 sites
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Callao, CALLAO 02
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Lima, 0051
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Lima, LIMA 29
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Lima, LIMA 31
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Lima, Lima 32
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Lima, LIMA 34
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San Isidro, 27
Philippines7 sites
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Baguio City, 2600
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Cebu City, 6000
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Davao City, 8000
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Iloilo City, 5000
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Quezon City, 1101
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Quezon City, 1112
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San Juan City, 1500
Slovakia7 sites
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Bratislava, 81102
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Bratislava, 851 05
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Martin, 036 59
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Nitra, 49401
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Prešov, 08001
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Šaľa, 92701
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Trenčín, 911 01
Thailand7 sites
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Bangkok, 10210
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Bangkok, 10400
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Bangkok, 10700
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Chiang Mai, 50200
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Hat Yai, 90110
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Lampang, 52000
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Muang, 22000
Czechia6 sites
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Brno, 656 91
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Hořovice, 268 31
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Hradec Králové, 500 05
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Prague, 100 34
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Prague, 120 00
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Prague, 180 81
Israel6 sites
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Haifa, 3109601
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Jerusalem, 91120
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Kfar Saba, 95847
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Petah Tikva, 4941492
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Ramat Gan, 52621
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Ẕerifin, 70300
Mexico6 sites
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Culiacán, 80040
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Culiacán, 80230
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Guadalajara, 44680
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Mexico City, 0 3100
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Monterrey, 64460
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Monterrey, 64710
Netherlands6 sites
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Amsterdam, 1066 CX
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Hilversum, 1212 VG
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Roosendaal, 4708 AE
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The Hague, 2545 AA
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Tilburg, 5042AD
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Utrecht, 3543 AZ
South Africa6 sites
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Cape Town, 7570
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Johannesburg, 2013
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Johannesburg, 2193
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Parow, 7505
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Port Elizabeth, 6045
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Pretoria, 0084
United Kingdom6 sites
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Cambridge, CB2 0QQ
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Guildford, GU2 7XX
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Manchester, M20 4BX
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Plymouth, PL6 8DH
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Sutton, SM2 5PT
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Whitchurch, CF14 2TL
Australia5 sites
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Birtinya, 4575
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Darlinghurst, 2010
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Kingswood, 2747
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Orange, 2800
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South Brisbane, 4101
Chile5 sites
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Santiago, 7500653
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Santiago, 7500787
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Santiago, 8420383
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Temuco, 4781156
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Viña del Mar, 2540488
Belgium4 sites
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Anderlecht, 1070
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Ghent, 9000
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Kortrijk, 8500
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Liège, 4000
Austria3 sites
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Graz, 8036
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Linz, 4020
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Salzburg, 5020
Hong Kong3 sites
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Hong Kong, 00000
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Hong Kong
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Lai Chi Kok
Vietnam3 sites
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Hà Nội, 100000
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Hanoi, 100000
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Ho Chi Minh City, 700000
About this study
Official title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.
- Conditions
- Hormone-Sensitive Prostate Cancer
- Being tested
- Capivasertib, Placebo, Abiraterone Acetate
- Keywords
- Prostate cancer, De Novo Metastatic Prostate cancer, PTEN, PTEN deficiency, Hormones, Hormone-Sensitive, Androgen Deprivation Therapy, Capivasertib, Abiraterone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapivasertibDrug
400 mg (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
PlaceboOther
matched to capivasertib appearance (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
Abiraterone AcetateDrug
Also called ZYTIGA, Novadoz
Administered orally as tablets at a dosage of 1000 mg daily. Administered continuously until criteria for discontinuation are met.
| Study group | Role | What they receive |
|---|---|---|
| Capivasertib + Abiraterone | Experimental | Participants receive capivasertib in combination with abiraterone (prednisone/prednisolone) on a background of ADT. Receives: Drug: Capivasertib; Drug: Abiraterone Acetate |
| Placebo + Abiraterone | Placebo comparator | Participants receive placebo in combination with abiraterone (prednisone/prednisolone) on a background of ADT. Receives: Other: Placebo; Drug: Abiraterone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-free Survival (rPFS)
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone, or death due to any cause for each study arm.
Measured: Tumor assessments every 16 weeks from randomisation until radiographic progression assessed by the investigator. The timing of the Primary analysis DCO for rPFS is approximately 49 months from the first subject randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start13 Jul 2020
- Primary completion7 Oct 2024
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormone-Sensitive Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 1000 participants are assigned to one of the two parallel groups (1:1 ratio) to receive either capivasertib or placebo, in combination with abiraterone on a background of ADT for the duration of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493853
- Sponsor's protocol ID
- D361BC00001
- Other IDs
- 2023-504998-20-00, 2020-000346-33, 2023
- Acronym
- CAPItello-281
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2020
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Fizazi K, Clarke NW, De Santis M, Uemura H, Fay AP, Karadurmus N, Kwiatkowski M, Alvarez-Fernandez C, Jiang S, Sotelo M, Parslow D, Oliveira N, Kwon TG, Ye D, Boudewijns S, Danchaivijitr P, Rooney C, Gresty C, Yeste-Velasco M, Logan J, George DJ; CAPItello-281 Study Group. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026 Jan;37(1):53-68. doi: 10.1016/j.annonc.2025.10.004. Epub 2025 Oct 19.
PubMed 41120017