Hormone-Sensitive Prostate Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Capivasertib, Abiraterone
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Inves
Sponsors
Astrazeneca K.K
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Asymptomatic or mildly symptomatic, histologically-confirmed de novo hormone-sensitive prostate adenocarcinoma without small-cell tumours diagnosed within 180 days of randomization - 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 or more and/or 1 soft tissue lesion or more 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 - 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
Exclusion criteria
Exclusion criteria: - 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: i. 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. iii. Family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives. iv. Medical history significant for arrhythmia which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. v. 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. viii. -Congestive heart failure NYHA Grade 2 ix or more. - Symptomatic hypotension - systolic blood pressure (SBP) 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, h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics - | — |
Countries
and Asia (including China and Japan), Approximately 30 countries in Europe, Australia, North America, South America
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed