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Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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)

NCT05348577•AstraZeneca

View on ClinicalTrials.gov

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 and/or the radiographic progression free survival of study participants.

Eligibility

Age

18 - 130 years

Sex

MALE

Healthy Volunteers

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
+1 more criteria

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.
+14 more criteria

Locations (217)

Research Site

Yuma, Arizona, United States

Research Site

Beverly Hills, California, United States

Research Site

Cerritos, California, United States

Research Site

Fresno, California, United States

Research Site

Los Angeles, California, United States

Research Site

Sacramento, California, United States

Research Site

San Francisco, California, United States

Research Site

Santa Barbara, California, United States

Research Site

Santa Monica, California, United States

Research Site

Santa Rosa, California, United States

Key Dates

Start Date

March 25, 2022

Primary Completion Date

March 4, 2026

Completion Date

March 4, 2026

Last Updated

January 27, 2025

Enrollment

1,035

ACTUAL participants

Conditions

Prostate Cancer

Interventions

capivasertib

DRUG

docetaxel

DRUG

placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

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