Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) (CAPItello280)

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival and/or the radiographic progression free survival of study participants.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: capivasertib; Drug: docetaxel; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 1035
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Birtinya, Australia, 4575
    • Research Site
  • Greenslopes, Australia, 4120
    • Research Site
  • Kogarah, Australia, 2217
    • Research Site
  • North Adelaide, Australia, 5000
    • Research Site
  • Orange, Australia, 2800
    • Research Site
  • Redcliffe, Australia, 4020
    • Research Site
  • Wahroonga, Australia, 2076
    • Research Site
• Belgium
  • Brasschaat, Belgium, 2930
    • Research Site
  • Gent, Belgium, 9000
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
• Brazil
  • Cachoeiro de Itapemirim, Brazil, 29308-014
    • Research Site
  • Ijuí, Brazil, 98700-000
    • Research Site
  • Itajai, Brazil, 88301-220
    • Research Site
  • Joinville, Brazil, 89201-470
    • Research Site
  • Porto Alegre, Brazil, 90020-090
    • Research Site
  • Porto Alegre, Brazil, 90110-270
    • Research Site
  • Porto Alegre, Brazil, 90160-093
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Research Site
  • Recife, Brazil, 50040-000
    • Research Site
  • Rio De Janeiro, Brazil, 22793-080
    • Research Site
  • Rio de Janeiro, Brazil, 22281-100
    • Research Site
  • Salvador, Brazil, 41253-190
    • Research Site
  • Salvador, Brazil, 41820-021
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  • Santa Maria, Brazil, 97015-450
    • Research Site
  • Sao Paulo, Brazil, 01509-900
    • Research Site
  • São José Do Rio Preto - SP, Brazil, 15090-000
    • Research Site
  • São Paulo, Brazil, 01221-020
    • Research Site
  • São Paulo, Brazil, 04014-002
    • Research Site
  • Tres Lagoas, Brazil, 79601-001
    • Research Site
• Canada
  • Toronto, Canada, M4N 3M5
    • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Research Site
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Research Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
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• Chile
  • Santiago, Chile, 7500713
    • Research Site
  • Santiago, Chile, 7500918
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  • Santiago, Chile, 7650568
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  • Vina del Mar, Chile, 2520000
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• China
  • Beijing, China, 100021
    • Research Site
  • Beijing, China, 100034
    • Research Site
  • Beijing, China, 100050
    • Research Site
  • Changsha, China, 410013
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  • Changsha, China, 410008
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  • Chengdu, China, 610041
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  • Chengdu, China, 610072
    • Research Site
  • Chongqing, China, 400038
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  • Guangzhou, China, 510180
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  • Hangzhou, China, 310003
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  • Hangzhou, China, 310000
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  • Harbin, China, 150040
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  • Jiaxing, China, 314001
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  • Nanchang, China, 330019
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  • Nanjing, China, 210008
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  • Nantong, China, 226361
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  • Ningbo, China, 315010
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  • Shanghai, China, 200032
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  • Shanghai, China, 200040
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  • Shenyang, China, 110042
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  • Tianjin, China, 300052
    • Research Site
  • Wuhan, China, 430079
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  • Wuhan, China, 430030
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  • Yantai, China, 264000
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  • Zhengzhou, China, 450008
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• Czechia
  • Horovice, Czechia, 268 01
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  • Hradec Kralove, Czechia, 500 05
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  • Pardubice, Czechia, 532 03
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  • Praha 10, Czechia, 10034
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  • Praha 4, Czechia, 14059
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  • Praha 5, Czechia, 150 06
    • Research Site
• France
  • Bordeaux, France, 33076
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  • Brest, France, 29609
    • Research Site
  • Clermont-Ferrand CEDEX 01, France, 63011
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  • Creteil, France, 94010
    • Research Site
  • Montpellier, France, 34298
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  • Paris, France, 75020
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  • Paris, France, 75014
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  • Rouen, France, 76031
    • Research Site
  • Saint Herblain Cedex, France, 44805
    • Research Site
  • Saint-Mande, France, 94160
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  • Strasbourg, France, 67000
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  • Strasbourg, France, 67033
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  • Vandoeuvre Les Nancy, France, 54000
    • Research Site
  • Villejuif Cedex, France, 94805
    • Research Site
• Greece
  • Athens, Greece, 115 22
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  • Athens, Greece, 155 62
    • Research Site
  • Chaidari, Greece, 124 62
    • Research Site
  • Marousi, Greece, 151 23
    • Research Site
  • Patras, Greece, 26504
    • Research Site
  • Peiraias, Greece, 185 47
    • Research Site
• Hungary
  • Budapest, Hungary, 1125
    • Research Site
  • Budapest, Hungary, 1145
    • Research Site
  • Budapest, Hungary, 1122
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  • Budapest, Hungary, 1097
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  • Kecskemét, Hungary, 6000
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  • Nyiregyhaza, Hungary, 4400
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  • Szeged, Hungary, 6725
    • Research Site
  • Szolnok, Hungary, 5000
    • Research Site
• India
  • Bikaner, India, 334003
    • Research Site
  • Meerut, India, 250001
    • Research Site
  • Mohali, India, 160055
    • Research Site
  • New Delhi, India, 110085
    • Research Site
• Israel
  • Be'er Ya'akov, Israel, 70300
    • Research Site
  • Haifa, Israel, 3109601
    • Research Site
  • Jerusalem, Israel, 91120
    • Research Site
  • Kfar Sava, Israel, 44281
    • Research Site
  • Petah Tikva, Israel, 4941492
    • Research Site
  • Ramat Gan, Israel, 52621
    • Research Site
  • Tel Aviv, Israel, 6423906
    • Research Site
• Japan
  • Chiba-shi, Japan, 260-8717
    • Research Site
  • Hirakata-shi, Japan, 573-1191
    • Research Site
  • Hirosaki-shi, Japan, 036-8563
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  • Kanazawa-shi, Japan, 920-8641
    • Research Site
  • Kashihara-shi, Japan, 634-8522
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  • Kita-gun, Japan, 761-0793
    • Research Site
  • Kobe-shi, Japan, 650-0047
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  • Kumamoto-shi, Japan, 860-0008
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  • Miyazaki-shi, Japan, 889-1692
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  • Nagano-Shi, Japan, 381-8551
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  • Nagoya-shi, Japan, 466-8560
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  • Nakano-Ku, Japan, 164-0001
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  • Osaka-shi, Japan, 541-8567
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  • Osakasayama-shi, Japan, 589-8511
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  • Sagamihara-shi, Japan, 252-0375
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  • Sapporo-shi, Japan, 003-0804
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  • Tsu-shi, Japan, 514-8507
    • Research Site
  • Wakayama-shi, Japan, 641-8510
    • Research Site
  • Yokohama-shi, Japan, 232-0024
    • Research Site
• Korea, Republic of
  • Bukgu, Korea, Republic of, 41404
    • Research Site
  • Busan, Korea, Republic of, 602-739
    • Research Site
  • Goyang-si, Korea, Republic of, 10408
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 06591
    • Research Site
  • Seoul, Korea, Republic of, 6273
    • Research Site
• Mexico
  • Aguascalientes, Mexico, 20116
    • Research Site
  • Ciudad de México, Mexico, 03840
    • Research Site
  • Culiacan, Mexico, 80230
    • Research Site
  • Guadalajara, Mexico, 44680
    • Research Site
  • Guadalajara, Mexico, 44260
    • Research Site
  • Mexico, Mexico, 04700
    • Research Site
  • Oaxaca, Mexico, 68000
    • Research Site
  • Zapopan, Mexico, 45116
    • Research Site
• Netherlands
  • Den Haag, Netherlands, 2545 CH
    • Research Site
  • Hoofddorp, Netherlands, 2134 TM
    • Research Site
• Poland
  • Nowa Sol, Poland, 67-106
    • Research Site
  • Opole, Poland, 45-061
    • Research Site
  • Wieliszew, Poland, 05-135
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Barcelona, Spain, ?08041
    • Research Site
  • Cordoba, Spain, 14004
    • Research Site
  • Lugo, Spain, 27003
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Malaga, Spain, 29010
    • Research Site
  • Sabadell, Spain, 08208
    • Research Site
  • Sevilla, Spain, 41013
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 81362
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Tainan, Taiwan, 710
    • Research Site
  • Taipei, Taiwan, 10002
    • Research Site
  • Taipei, Taiwan, 11259
    • Research Site
• Turkey
  • Adana, Turkey, 01060
    • Research Site
  • Edirne, Turkey, 22030
    • Research Site
  • Izmir, Turkey, 35575
    • Research Site
  • Sahinbey, Turkey, 27310
    • Research Site
  • Yüreğir, Turkey, 01240
    • Research Site
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Research Site
  • Glasgow, United Kingdom, G12 0YN
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  • Guildford, United Kingdom
    • Research Site
  • Hackensack, United Kingdom, 07601-1963
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  • London, United Kingdom, SE1 9RT
    • Research Site
  • London, United Kingdom, SW7 3RP
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  • Manchester, United Kingdom, M20 4BX
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  • Southampton, United Kingdom, SO16 6YD
    • Research Site
  • Sutton, United Kingdom, SM2 5PT
    • Research Site
• United States
  • Arizona
    • Yuma, Arizona, United States, 85364
      • Research Site
  • California
    • Beverly Hills, California, United States, 90211
      • Research Site
    • Cerritos, California, United States, 90703
      • Research Site
    • Fresno, California, United States, 93701
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • Sacramento, California, United States, 95817
      • Research Site
    • San Francisco, California, United States, 94115
      • Research Site
    • Santa Barbara, California, United States, 93105
      • Research Site
    • Santa Monica, California, United States, 90404
      • Research Site
    • Santa Rosa, California, United States, 95403
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
    • Lakewood, Colorado, United States, 80228
      • Research Site
    • Littleton, Colorado, United States, 80120
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  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Research Site
    • Baltimore, Maryland, United States, 21287
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  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Research Site
    • Minneapolis, Minnesota, United States, 55416
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  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Research Site
  • New York
    • Albany, New York, United States, 12208
      • Research Site
    • Bronx, New York, United States, 10461
      • Research Site
    • White Plains, New York, United States, 10601
      • Research Site
  • Ohio
    • Toledo, Ohio, United States, 43623
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97223
      • Research Site
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004-1017
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19111
      • Research Site
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Research Site
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Research Site
  • Texas
    • Austin, Texas, United States, 78731
      • Research Site
    • Dallas, Texas, United States, 75235
      • Research Site
    • Houston, Texas, United States, 77096
      • Research Site
    • Kingwood, Texas, United States, 77339
      • Research Site
    • San Antonio, Texas, United States, 78217
      • Research Site
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98109
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically-confirmed prostate adenocarcinoma without predominant neuroendocrine or small cell cancers
• Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable or non-measurable)
• Patient must have been previously treated with a next generation hormonal agent (NHA), ie, abiraterone, enzalutamide, apalutamide or darolutamide, for prostate cancer for at least 3 months and shown evidence of disease progression (radiological or via PSA assessment) while receiving the NHA
• Evidence of mCRPC with progression of disease despite androgen deprivation therapy (ADT)
• Serum testosterone level ≤ 50 ng/dL
• Candidate for docetaxel and steroid therapy
• Ongoing ADT with LHRH agonist, LHRH antagonist, or bilateral orchiectomy
• Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1 and anticipated minimum life expectancy of 12 weeks
• Confirmation that archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample which meets the minimum pathology and sample requirements is available to send to the central laboratory
• Able and willing to swallow and retain oral medication
• Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

• Radiotherapy with a wide field of radiation within 4 weeks before start of study treatment
• Major surgery (excl. placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, internal stents) within 4 weeks of start of study treatment
• Brain metastases,or spinal cord compression (unless spinal cord compression is asymptomatic and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)

• Any of the following cardiac criteria:

  i. Mean resting corrected QT interval (QTc) >470 msec from 3 consecutive ECGs ii. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG iii. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age,or any concomitant medication known to prolong the QT interval iv. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade ≥2 v. Symptomatic hypotension - systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg vi. haemodinamic instability

• Clinically significant abnormalities of glucose metabolism as defined by any of the following:

  i. Patients with diabetes mellitus (DM) type 1 or DM 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:

  i. 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 per the Cockcroft and Gault formula without the need for chronic dialysis;

• As judged by the investigator, any evidence of diseases (including severe or uncontrolled systemic diseases, uncontrolled hypertension, history of interstitial pneumonia / pneumonitis or interstitial lung disease, renal transplant and active bleeding diseases), which, in the investigator's opinion, makes it undesirable for the patient to participate in the study or that would jeopardise compliance with the protocol.
• 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, 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.
• Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy, excluding alopecia. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included (eg, hearing loss)
• Known to have active hepatitis infection.
• Known to have human immunodeficiency virus (HIV) with a detectable viral RNA load or a CD4+ T-cell count < 350 cells/uL or a history of an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, or receiving anti-HIV medications for less than 4 weeks.
• Known to have active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).

• Treatment with any of the following:

  i. Prior chemotherapy for CRPC. Chemotherapy for metastatic or localized HSPC (including docetaxel) is allowed provided that chemotherapy was completed ≥ 6months before randomisation and progression of the prostate cancer occurred ≥ 6months after the completion of therapy.

ii. Prior exposure to AKT inhibitors or PI3K inhibitors iii. 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 iv. Any other immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents (except ADT) within 3 weeks of the first dose of study treatment v. Strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), vi.Use of any live vaccine administration 30 days prior to the initiation of study treatment, during, and for at least 90 days after the last dose of the study treatment

• Drugs known to significantly prolong the QT interval and associated with Torsade de Pointes within 5 half-lives of the first dose of study treatment
• History of hypersensitivity to active or inactive excipients of capivasertib, docetaxel, or drugs with a similar chemical structure or class
• Any restriction or contraindication based on the local prescribing information that would prohibit the use of docetaxel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: capivasertib + docetaxel; Participants receive capivasertib in combination with docetaxel and steroids on a background of ADT.	Drug: capivasertib; 320 mg (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 2 to 5, 9 to 12, and 16 to 19 in each week of a 21-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops, death, or if the patient requests to stop the study treatment.; Drug: docetaxel; Patients will receive docetaxel in intravenous infusion, 75 mg/m2 BSA, on Day 1 of the 21-day cycles for up to 6 to 10 cycles, according to standard of care practices.
Placebo Comparator: placebo + docetaxel; Participants receive placebo in combination with docetaxel and steroids on a background of ADT.	Drug: docetaxel; Patients will receive docetaxel in intravenous infusion, 75 mg/m2 BSA, on Day 1 of the 21-day cycles for up to 6 to 10 cycles, according to standard of care practices.; Other: placebo; matched to capivasertib appearance (2 tablets) BD given orally on an intermittent weekly dosing schedule. Patients will be dosed on Days 2 to 5, 9 to 12, and 16 to 19 in each week of a 21-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops, death, or if the patient requests to stop the study treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in the overall population	Overall survival is defined as time from randomisation until the date of death due to any cause.	up to approximately 46 months
Radiographic Progression-free Survival (rPFS) in the overall population	Radiographic Progression-free Survival (rPFS) is defined as time from randomization to radiographic progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone or death due to any cause	up to approximately 37 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of capivasertib derived from a population PK model in the overall population		pre dose (up to 90 minutes prior) and post dose (1 hour, 2 hours and 4 hours post dose)
Overall Survival (OS) in patients with mCRPC and PTEN-proficient tumours (IHC)	OS is defined as time from randomisation until the date of death due to any cause.	up to approximately 46 months
Overall Survival (OS) in patients with mCRPC and PTEN-deficient tumours (IHC).	OS is defined as time from randomisation until the date of death due to any cause.	up to approximately 46 months
Radiographic Progression-free Survival (rPFS) in patients with mCRPC and PTEN-proficient tumours (IHC)	Radiographic progression-free survival is defined as the time from randomisation to radiographic progression, as assessed by the investigator at local site per RECIST version 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.	up to approximately 37 months
Radiographic Progression-free Survival (rPFS) in patients with mCRPC and PTEN-deficient tumours (IHC)	Radiographic progression-free survival is defined as the time from randomisation to radiographic progression, as assessed by the investigator at local site per RECIST version 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.	up to approximately 37 months
Time to pain progression (TTPP) in the overall population	Time to pain progression (TTPP) based on a 2-point increase from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Item 3 'pain at its worse in the last 24 hours' score (scale from 0 ["no pain"] to 10 ["pain as bad as you can imagine"]) and/or initiation of/increase in opioid analgesic use.	up to approximately 37 months
Time to first Symptomatic Skeletal-Related Event (SSRE) in the overall population	SSRE is defined as time from randomisation until any of the following: use of radiation therapy to prevent or relieve skeletal symptoms; Occurrence of new symptomatic pathological bone fractures; Occurrence of spinal cord compression; Orthopaedic surgical intervention for bone metastasis	up to approximately 46 months
Time to deterioration in urinary symptoms (TTDUS) in the overall population	Time to deterioration in urinary symptoms (TTDUS) is defined as time from randomization until the change from baseline reaches a clinically meaningful deterioration threshold using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Prostate Questionnaire Urinary Symptoms (QLQ-PR25 (US)) subscale score (EORTC IL166), where the question responses are provided on a numerical rating scale ranging from 1 ("not at all") to 4 ("very much").	up to approximately 37 months
Time to deterioration in Physical Functioning (TTDPF) in the overall population	Time to deterioration in Physical Functioning (TTDPF) is defined as the time from randomization until the change from baseline reaches a clinically meaningful deterioration threshold using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Physical Functioning (QLQ-C30 PF) subscale score (EORTC IL166), where the question responses are provided on a numerical rating scale ranging from 1 ("not at all") to 4 ("very much").	up to approximately 37 months
Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire in the overall population	Change from baseline in Brief Pain Inventory-Short Form (BPI-SF) pain at its worse in the last 24 hours score (scale from 0 ["no pain"] to 10 ["pain as bad as you can imagine"]), pain severity (the mean of the four pain severity items each of which ranges from 0 ["no pain"] to 10 ["pain as bad as you can imagine"]) and interference domain scores (the mean of the seven pain interference items each of which ranges from 0 ["does not interfere"] to 10 ["completely interferes"]).	up to approximately 37 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants with adverse events in the overall population	Data will include clinical observations, ECG parameters, clinical chemistry / haematology / glucose metabolism parameters and vital signs assessed as the number of participants with adverse events.	Up to approximately 46 months
Systolic and diastolic blood pressure	millimetre of mercury (mmHg)	Up to approximately 46 months
Pulse rate (heart rate)	Beats per minute (BPM)	Up to approximately 46 months
Body Temperature	Celsius (°C)	Up to approximately 46 months
Weight	Kilograms (kg)	Up to approximately 46 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Estimated): March 4, 2026
• Study Completion (Estimated): March 4, 2026

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: metastatic; docetaxel; castration resistant; prostate cancer,; capivasertib,; AKT inhibitor,
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: D361EC00001; 2021-005201-27 (EudraCT Number); 2023-504996-26-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

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 shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No