Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
- Conditions
- Prostate cancer
- Registration Number
- JPRN-jRCT2080223518
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 1100
Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
- FFPE tissue block (preferred) or a minimum of 15 (20 preferred) freshly cut unstained tumor slides
- A valid PTEN IHC result (central laboratory tested with results directly sent to IxRS)
- Metastatic disease documented prior to randomization by clear evidence of bone lesions on bone scan and/or measurable soft tissue disease by CT and/or MRI (at least one target lesion) according to RECIST v1.1
- Asymptomatic or mildly symptomatic form of prostate cancer
- Progressive disease before initiating study treatment
- Ongoing androgen deprivation with GnRH analog or bilateral orchiectomy
- Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate
- Any therapy for the treatment of castration resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or 5-alpha reductase inhibitor is permitted.
- Prior treatment with abiraterone or other known potent CYP17 inhibitors or investigational agents that block androgen synthesis
- Prior treatment with enzalutamide or other potent androgen-receptor blockers
- Use of opioid medication for cancer-related pain
- Any prior anti-cancer therapy
- Known untreated or active CNS metastases
- Uncontrolled hypertension
- History of pituitary or adrenal dysfunction
- Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical therapy
- Any chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or inhibitors or sensitive substrates of CYP3A or CYP2D6 with a narrow therapeutic window
- Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
- History of inflammatory bowel disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>PCWG3 criteria, RECIST ver1.1
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>confirmatory<br>other<br>Obserbation, PCWG3 criteria, RECIST ver1.1,