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AzTrials

Prostate CancerPhase 3CAPItello280NCT05348577

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

A Phase 3 study testing capivasertib and docetaxel in people with Prostate Cancer, run by AstraZeneca at 217 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 130 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
capivasertib and docetaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,035 participants
Where
217 sitesin 22 countries
Study dates
25 Mar 2022to 4 Mar 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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:
  • 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:
Show all 24Show fewer
  • 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:
  • 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:
  • 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.
  • 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

Trial locations and contacts

217 sites in 22 countries.

217 sites in 22 countries

United States37 sites

  • Research Site

    Albany, New York, 12208

  • Research Site

    Aurora, Colorado, 80045

  • Research Site

    Austin, Texas, 78731

  • Research Site

    Bala-Cynwyd, Pennsylvania, 19004-1017

  • Research Site

    Baltimore, Maryland, 21201

  • Research Site

    Baltimore, Maryland, 21287

  • Research Site

    Beverly Hills, California, 90211

  • Research Site

    Cerritos, California, 90703

  • Research Site

    Chattanooga, Tennessee, 37404

  • Research Site

    Chesapeake, Virginia, 23320

  • Research Site

    Dallas, Texas, 75235

  • Research Site

    Fresno, California, 93701

  • Research Site

    Greenville, South Carolina, 29605

  • Research Site

    Hackensack, New Jersey, 07601

  • Research Site

    Houston, Texas, 77096

  • Research Site

    Kingwood, Texas, 77339

  • Research Site

    Lakewood, Colorado, 80228

  • Research Site

    Littleton, Colorado, 80120

  • Research Site

    Los Angeles, California, 90095

  • Research Site

    Minneapolis, Minnesota, 55404

  • Research Site

    Minneapolis, Minnesota, 55416

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    Philadelphia, Pennsylvania, 19107

  • Research Site

    Philadelphia, Pennsylvania, 19111

  • Research Site

    Portland, Oregon, 97223

  • Research Site

    Sacramento, California, 95817

  • Research Site

    San Antonio, Texas, 78217

  • Research Site

    San Francisco, California, 94115

  • Research Site

    Santa Barbara, California, 93105

  • Research Site

    Santa Monica, California, 90404

  • Research Site

    Santa Rosa, California, 95403

  • Research Site

    Seattle, Washington, 98109

  • Research Site

    The Bronx, New York, 10461

  • Research Site

    Toledo, Ohio, 43623

  • Research Site

    Watertown, South Dakota, 57201

  • Research Site

    White Plains, New York, 10601

  • Research Site

    Yuma, Arizona, 85364

Other trials in United States

China25 sites

  • Research Site

    Beijing, 100021

  • Research Site

    Beijing, 100034

  • Research Site

    Beijing, 100050

  • Research Site

    Changsha, 410008

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610041

  • Research Site

    Chengdu, 610072

  • Research Site

    Chongqing, 400038

  • Research Site

    Guangzhou, 510180

  • Research Site

    Hangzhou, 310000

  • Research Site

    Hangzhou, 310003

  • Research Site

    Harbin, 150040

  • Research Site

    Jiaxing, 314001

  • Research Site

    Nanchang, 330019

  • Research Site

    Nanjing, 210008

  • Research Site

    Nantong, 226361

  • Research Site

    Ningbo, 315010

  • Research Site

    Shanghai, 200032

  • Research Site

    Shanghai, 200040

  • Research Site

    Shenyang, 110042

  • Research Site

    Tianjin, 300052

  • Research Site

    Wuhan, 430030

  • Research Site

    Wuhan, 430079

  • Research Site

    Yantai, 264000

  • Research Site

    Zhengzhou, 450008

Other trials in China

Brazil19 sites

  • Research Site

    Cachoeiro de Itapemirim, 29308-014

  • Research Site

    Ijuí, 98700-000

  • Research Site

    Itajaí, 88301-220

  • Research Site

    Joinville, 89201-470

  • Research Site

    Porto Alegre, 90020-090

  • Research Site

    Porto Alegre, 90035-903

  • Research Site

    Porto Alegre, 90110-270

  • Research Site

    Porto Alegre, 90160-093

  • Research Site

    Recife, 50040-000

  • Research Site

    Rio de Janeiro, 22281-100

  • Research Site

    Rio de Janeiro, 22793-080

  • Research Site

    Salvador, 41253-190

  • Research Site

    Salvador, 41820-021

  • Research Site

    Santa Maria, 97015-450

  • Research Site

    São José Do Rio Preto - SP, 15090-000

  • Research Site

    São Paulo, 01221-020

  • Research Site

    São Paulo, 01509-900

  • Research Site

    São Paulo, 04014-002

  • Research Site

    Três Lagoas, 79601-001

Other trials in Brazil

Japan19 sites

  • Research Site

    Chiba, 260-8717

  • Research Site

    Hirakata-shi, 573-1191

  • Research Site

    Hirosaki-shi, 036-8563

  • Research Site

    Kanazawa, 920-8641

  • Research Site

    Kashihara-shi, 634-8522

  • Research Site

    Kita-gun, 761-0793

  • Research Site

    Kobe, 650-0047

  • Research Site

    Kumamoto, 860-0008

  • Research Site

    Miyazaki, 889-1692

  • Research Site

    Nagano, 381-8551

  • Research Site

    Nagoya, 466-8560

  • Research Site

    Nakano, 164-0001

  • Research Site

    Osaka, 541-8567

  • Research Site

    Osakasayama-shi, 589-8511

  • Research Site

    Sagamihara-shi, 252-0375

  • Research Site

    Sapporo, 003-0804

  • Research Site

    Tsu, 514-8507

  • Research Site

    Wakayama, 641-8510

  • Research Site

    Yokohama, 232-0024

Other trials in Japan

France14 sites

  • Research Site

    Bordeaux, 33076

  • Research Site

    Brest, 29609

  • Research Site

    Clermont-Ferrand, 63011

  • Research Site

    Créteil, 94010

  • Research Site

    Montpellier, 34298

  • Research Site

    Paris, 75014

  • Research Site

    Paris, 75020

  • Research Site

    Rouen, 76031

  • Research Site

    Saint-Herblain, 44805

  • Research Site

    Saint-Mandé, 94160

  • Research Site

    Strasbourg, 67000

  • Research Site

    Strasbourg, 67033

  • Research Site

    Vandœuvre-lès-Nancy, 54000

  • Research Site

    Villejuif, 94805

Other trials in France

Spain11 sites

  • Research Site

    Barcelona, 08003

  • Research Site

    Barcelona, 08035

  • Research Site

    Barcelona, 08036

  • Research Site

    Barcelona, ?08041

  • Research Site

    Córdoba, 14004

  • Research Site

    Lugo, 27003

  • Research Site

    Madrid, 28034

  • Research Site

    Madrid, 28040

  • Research Site

    Málaga, 29010

  • Research Site

    Sabadell, 08208

  • Research Site

    Seville, 41013

Other trials in Spain

United Kingdom9 sites

  • Research Site

    Edinburgh, EH4 2XU

  • Research Site

    Glasgow, G12 0YN

  • Research Site

    Guildford

  • Research Site

    Hackensack, 07601-1963

  • Research Site

    London, SE1 9RT

  • Research Site

    London, SW7 3RP

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Southampton, SO16 6YD

  • Research Site

    Sutton, SM2 5PT

Other trials in United Kingdom

Hungary8 sites

  • Research Site

    Budapest, 1097

  • Research Site

    Budapest, 1122

  • Research Site

    Budapest, 1125

  • Research Site

    Budapest, 1145

  • Research Site

    Kecskemét, 6000

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Szeged, 6725

  • Research Site

    Szolnok, 5000

Other trials in Hungary

Mexico8 sites

  • Research Site

    Aguascalientes, 20116

  • Research Site

    Culiacán, 80230

  • Research Site

    Guadalajara, 44260

  • Research Site

    Guadalajara, 44680

  • Research Site

    México, 04700

  • Research Site

    Mexico City, 03840

  • Research Site

    Oaxaca City, 68000

  • Research Site

    Zapopan, 45116

Other trials in Mexico

South Korea8 sites

  • Research Site

    Bukgu, 41404

  • Research Site

    Busan, 602-739

  • Research Site

    Goyang-si, 10408

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06591

  • Research Site

    Seoul, 6273

Other trials in South Korea

Australia7 sites

  • Research Site

    Birtinya, 4575

  • Research Site

    Greenslopes, 4120

  • Research Site

    Kogarah, 2217

  • Research Site

    North Adelaide, 5000

  • Research Site

    Orange, 2800

  • Research Site

    Redcliffe, 4020

  • Research Site

    Wahroonga, 2076

Other trials in Australia

Israel7 sites

  • Research Site

    Be’er Ya‘aqov, 70300

  • Research Site

    Haifa, 3109601

  • Research Site

    Jerusalem, 91120

  • Research Site

    Kfar Saba, 44281

  • Research Site

    Petah Tikva, 4941492

  • Research Site

    Ramat Gan, 52621

  • Research Site

    Tel Aviv, 6423906

Other trials in Israel

Canada6 sites

  • Research Site

    Halifax, Nova Scotia, B3H 2Y9

  • Research Site

    Montreal, Quebec, H3T 1E2

  • Research Site

    Oshawa, Ontario, L1G 2B9

  • Research Site

    Sherbrooke, Quebec, J1H 5N4

  • Research Site

    Toronto, Ontario, M5G 2M9

  • Research Site

    Toronto, M4N 3M5

Other trials in Canada

Czechia6 sites

  • Research Site

    Hořovice, 268 01

  • Research Site

    Hradec Králové, 500 05

  • Research Site

    Pardubice, 532 03

  • Research Site

    Prague, 10034

  • Research Site

    Prague, 14059

  • Research Site

    Prague, 150 06

Other trials in Czechia

Greece6 sites

  • Research Site

    Athens, 115 22

  • Research Site

    Athens, 155 62

  • Research Site

    Chaïdári, 124 62

  • Research Site

    Marousi, 151 23

  • Research Site

    Pátrai, 26504

  • Research Site

    Piraeus, 185 47

Other trials in Greece

Taiwan6 sites

  • Research Site

    Kaohsiung City, 81362

  • Research Site

    Taichung, 40447

  • Research Site

    Tainan, 704

  • Research Site

    Tainan, 710

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 11259

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Research Site

    Adana, 01060

  • Research Site

    Edirne, 22030

  • Research Site

    Izmir, 35575

  • Research Site

    Şahinbey, 27310

  • Research Site

    Yüreğir, 01240

Other trials in Turkey (Türkiye)

Chile4 sites

  • Research Site

    Santiago, 7500713

  • Research Site

    Santiago, 7500918

  • Research Site

    Santiago, 7650568

  • Research Site

    Viña del Mar, 2520000

Other trials in Chile

India4 sites

  • Research Site

    Bikaner, 334003

  • Research Site

    Meerut, 250001

  • Research Site

    Mohali, 160055

  • Research Site

    New Delhi, 110085

Other trials in India

Belgium3 sites

  • Research Site

    Brasschaat, 2930

  • Research Site

    Ghent, 9000

  • Research Site

    Liège, 4000

Other trials in Belgium

Poland3 sites

  • Research Site

    Nowa Sól, 67-106

  • Research Site

    Opole, 45-061

  • Research Site

    Wieliszew, 05-135

Other trials in Poland

Netherlands2 sites

  • Research Site

    Hoofddorp, 2134 TM

  • Research Site

    The Hague, 2545 CH

Other trials in Netherlands

About this study

Official title: 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.

Conditions
Prostate Cancer
Being tested
capivasertib, docetaxel, placebo
Keywords
prostate cancer,, metastatic, castration resistant, capivasertib,, AKT inhibitor,, docetaxel
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capivasertibDrug

    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.

  • docetaxelDrug

    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.

  • placeboOther

    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.

Study groups in NCT05348577
Study groupRoleWhat they receive
capivasertib + docetaxelExperimentalParticipants receive capivasertib in combination with docetaxel and steroids on a background of ADT.
Receives: Drug: capivasertib; Drug: docetaxel
placebo + docetaxelPlacebo comparatorParticipants receive placebo in combination with docetaxel and steroids on a background of ADT.
Receives: Drug: docetaxel; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in the overall population

    Overall survival is defined as time from randomisation until the date of death due to any cause.

    Measured: up to approximately 46 months

  2. 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

    Measured: up to approximately 37 months

Secondary outcomes (10)

  1. 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.

    Measured: up to approximately 46 months

  2. 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.

    Measured: up to approximately 46 months

  3. 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.

    Measured: up to approximately 37 months

  4. 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.

    Measured: up to approximately 37 months

  5. 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.

    Measured: up to approximately 37 months

  6. 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

    Measured: up to approximately 46 months

  7. 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").

    Measured: up to approximately 37 months

  8. 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").

    Measured: up to approximately 37 months

  9. 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"]).

    Measured: up to approximately 37 months

  10. Plasma concentration of capivasertib derived from a population PK model in the overall population

    Measured: pre dose (up to 90 minutes prior) and post dose (1 hour, 2 hours and 4 hours post dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study start25 Mar 2022
  3. Primary completion4 Mar 2026 (estimated)
  4. Study completion4 Mar 2026 (estimated)

Resources

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 1350 participants will be enrolled and screened to achieve a total of approximately 1000 assigned in a 1:1 ratio to one of the two parallel groups to receive either capivasertib or placebo, in combination with docetaxel on a background of ADT for the duration of the study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,035 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05348577
Sponsor's protocol ID
D361EC00001
Other IDs
2023-504996-26-00, 2021-005201-27, 2023
Acronym
CAPItello280
Status last verified
Jan 2025
First submitted
18 Mar 2022
Last updated
27 Jan 2025
Results posted
No
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. 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capivasertib and docetaxel in people with Prostate Cancer, run by AstraZeneca at 217 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 217 sites in United States, China, Brazil, Japan, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in the overall population (time frame: up to approximately 46 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05348577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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