Prostate Cancer Clinical Trial
Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)
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. 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 of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.
Eligibility Criteria
Inclusion Criteria:
Histologically-confirmed prostate adenocarcinoma without 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) and after anti-androgen withdrawal if applicable
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, treated 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 6months: coronary artery bypass graft, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade ≥2 v. Uncontrolled hypotension - systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg vi. Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition scan if an echocardiogram cannot be performed or is inconclusive)
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 (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, 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 ≥5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy.
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 may be included (eg, hearing loss) after consultation with the medical monitor
Known to have active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis B virus core antibody at screening.
Known to have human immunodeficiency virus (HIV) with 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.
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 inducers of cytochrome P450 (CYP)3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or drugs that are sensitive to inhibition of CYP3A4 within 1 week prior to the first dose of study treatment
Drugs known to prolong the QT interval 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
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There are 240 Locations for this study
Gilbert Arizona, 85234, United States
Phoenix Arizona, 85004, United States
Beverly Hills California, 90211, United States
Fresno California, 93701, United States
Los Angeles California, 90095, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
Santa Monica California, 90404, United States
Santa Rosa California, 95403, United States
Aurora Colorado, 80045, United States
Lakewood Colorado, 80228, United States
Orange City Florida, 32763, United States
Chicago Ridge Illinois, 60415, United States
Chicago Illinois, 60612, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Minneapolis Minnesota, 55404, United States
Minneapolis Minnesota, 55416, United States
Hackensack New Jersey, 07601, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
White Plains New York, 10601, United States
Portland Oregon, 97223, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Greenville South Carolina, 29605, United States
Watertown South Dakota, 57201, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78731, United States
Dallas Texas, 75235, United States
Kingwood Texas, 77339, United States
San Antonio Texas, 78217, United States
Burlington Vermont, 05405, United States
Seattle Washington, 98109, United States
Birtinya , 4575, Australia
Kogarah , 2217, Australia
Miranda , 2228, Australia
North Adelaide , 5000, Australia
Orange , 2800, Australia
Redcliffe , 4020, Australia
Wahroonga , 2076, Australia
Woolloongabba , 4102, Australia
Brasschaat , 2930, Belgium
Gent , 9000, Belgium
Liège , 4000, Belgium
Wilrijk , 2610, Belgium
Yvoir , 5530, Belgium
Cachoeiro de Itapemirim , 29308, Brazil
Ijuà , 98700, Brazil
Itajai , 88310, Brazil
Joinville , 89201, Brazil
Porto Alegre , 90020, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90110, Brazil
Porto Alegre , 90160, Brazil
Recife , 50040, Brazil
Rio de Janeiro , 22281, Brazil
Rio De Janeiro , 22793, Brazil
Salvador , 41253, Brazil
Salvador , 41253, Brazil
Salvador , 41820, Brazil
Santa Maria , 97015, Brazil
São José Do Rio Preto - SP , 15090, Brazil
São Paulo , 01221, Brazil
São Paulo , 01509, Brazil
São Paulo , 04014, Brazil
Tres Lagoas , 79601, Brazil
Halifax Nova Scotia, B3H 2, Canada
Oshawa Ontario, L1G 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Sherbrooke Quebec, J1H 5, Canada
Toronto , M4N 3, Canada
Santiago , 75007, Chile
Santiago , 75009, Chile
Santiago , 76505, Chile
Temuco , 47811, Chile
Vina del Mar , 25200, Chile
Beijing , 10002, China
Beijing , 10003, China
Beijing , 10005, China
Changchun , 13001, China
Changsha , 41000, China
Changsha , 41001, China
Chengdu , 61004, China
Chengdu , 61007, China
Chongqing , 40003, China
Guangzhou , 51018, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Harbin , 15004, China
Jiaxing , 31400, China
Nanchang , 33001, China
Nanjing , 21000, China
Nantong , 22636, China
Ningbo , 31501, China
Shanghai , 20003, China
Shanghai , 20003, China
Shanghai , 20004, China
Shenyang , 11004, China
Shenzhen , 51803, China
Tianjin , 30005, China
Wuhan , 43003, China
Wuhan , 43007, China
Yantai , 26400, China
Zhengzhou , 45000, China
Horovice , 268 0, Czechia
Hradec Kralove , 500 0, Czechia
Pardubice , 532 0, Czechia
Praha 10 , 10034, Czechia
Praha 4 , 14059, Czechia
Praha 5 , 150 0, Czechia
Bordeaux , 33076, France
Brest , 29609, France
Clermont-Ferrand CEDEX 01 , 63011, France
Creteil , 94010, France
Marseille , 13385, France
Montpellier , 34000, France
Paris Cedex 05 , 75248, France
Paris , 75014, France
Paris , 75020, France
Rouen , 76031, France
Saint Herblain Cedex , 44805, France
Saint-Mande , 94160, France
Strasbourg , 67000, France
Strasbourg , 67200, France
Vandoeuvre Les Nancy , 54000, France
Villejuif Cedex , 94805, France
Athens , 115 2, Greece
Athens , 155 6, Greece
Chaidari , 124 6, Greece
Marousi , 151 2, Greece
Patras , 26504, Greece
Peiraias , 185 4, Greece
Budapest , 1097, Hungary
Budapest , 1122, Hungary
Budapest , 1125, Hungary
Budapest , 1145, Hungary
Kecskemét , 6000, Hungary
Nyiregyhaza , 4400, Hungary
Szeged , 6725, Hungary
Szolnok , 5000, Hungary
Bikaner , 33400, India
Meerut , 25000, India
Mohali , 16005, India
Nashik , 42200, India
New Delhi , 11008, India
Afula , 18341, Israel
Be'er Ya'akov , 70300, Israel
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Jerusalem , 93722, Israel
Kfar Sava , 44281, Israel
Petah Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Chiba-shi , 260-8, Japan
Hirakata-shi , 573-1, Japan
Hirosaki-shi , 036-8, Japan
Kanazawa-shi , 920-8, Japan
Kashihara-shi , 634-8, Japan
Kawagoe-shi , 350-8, Japan
Kita-gun , 761-0, Japan
Kobe-shi , 650-0, Japan
Kumamoto-shi , 860-0, Japan
Miyazaki-shi , 889-1, Japan
Nagano-Shi , 381-8, Japan
Nagoya-shi , 466-8, Japan
Nakano-Ku , 164-0, Japan
Osaka-shi , 541-8, Japan
Osakasayama-shi , 589-8, Japan
Sagamihara-shi , 252-0, Japan
Sapporo-shi , 003-0, Japan
Tsu-shi , 514-8, Japan
Wakayama-shi , 641-8, Japan
Yokohama-shi , 232-0, Japan
Bukgu , 41404, Korea, Republic of
Busan , 602-7, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 6273, Korea, Republic of
Aguascalientes , 20116, Mexico
Cancún , 77500, Mexico
Ciudad de México , 03840, Mexico
Culiacan , 80230, Mexico
Culiacán , 80020, Mexico
Guadalajara , 44260, Mexico
Guadalajara , 44680, Mexico
Mexico , 04700, Mexico
Oaxaca , 68000, Mexico
Zapopan , 45116, Mexico
Den Haag , 2545 , Netherlands
Hoofddorp , 2134 , Netherlands
Konin , 62-50, Poland
Lodz , 93-51, Poland
Nowa Sol , 67-10, Poland
Opole , 45-06, Poland
Warszawa , 02-78, Poland
Wieliszew , 05-13, Poland
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , ?0804, Spain
Cordoba , 14004, Spain
Lugo , 27003, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Sabadell , 08208, Spain
Sevilla , 41013, Spain
Kaohsiung , 81362, Taiwan
Taichung , 40044, Taiwan
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
Tainan , 710, Taiwan
Taipei , 10002, Taiwan
Taipei , 11259, Taiwan
Adana , 01060, Turkey
Ankara , 06010, Turkey
Ankara , 06100, Turkey
Ankara , 06800, Turkey
Edirne , 22030, Turkey
Istambul , 34899, Turkey
Izmir , 35360, Turkey
Izmir , 35575, Turkey
Sahinbey , 27310, Turkey
Yüreğir , 01240, Turkey
Bristol , BS2 8, United Kingdom
Cardiff , CF14 , United Kingdom
Edinburgh , EH4 2, United Kingdom
Glasgow , G12 0, United Kingdom
Guildford , , United Kingdom
Hackensack , 07601, United Kingdom
Hampstead , NW3 2, United Kingdom
London , SE1 9, United Kingdom
London , SW7 3, United Kingdom
Manchester , M20 4, United Kingdom
Southampton , SO16 , United Kingdom
Sutton , SM2 5, United Kingdom
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