Metastatic castration-resistant prostate cancer
Conditions
Interventions
Group A:PF-06821497(875mg,BID)+ENZALUTAMIDE(160mg,QD)
Group B:Placebo(875mg,BID)+ENZALUTAMIDE(160mg,QD)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male study participants aged > = 18 years (or the minimum age of informed consent as determined by local regulations) at screening. a. Reproductive criteria for male study participants are listed in Appendix 4 (Section 10.4.1). 2. Histologically or cytologically confirmed adenocarcinoma of the prostate (except for small cell features). For study participants without a prior histologic diagnosis, a baseline fresh biopsy sample must be used to confirm the diagnosis. 3. Bone scan results indicate metastases in the bones, or CT/MRI scan results indicate metastases in soft tissues. If there is no evaluable bone lesion (according to PCWG3 criteria), the presence of measurable soft tissue disease (according to RECIST v1.1) is required. ? PET and SPECT are not evaluable imaging modalities for this study. ? If a bone scan shows a strongly symmetrical bone metabolic activity in the bone, (known as a superimage), it is considered non-evaluable. For study participants with only measurable soft tissue lesions, only regional lymph node lesions (i.e., lymph node lesions below the aortic bifurcation) are not eligible to participate in the study. 4. Castration by surgery or medication, and serum testosterone levels = 1 week between measurements and a PSA value of > at the screening visit= 2 micrograms/L (minimum starting value of 1 ng/mL if confirmation of elevated PSA is the only indication for progression) (according to PCWG-3 criteria); b. Progression of soft tissue lesions as defined by RECIST 1.1. c. PCWG3-defined bone lesion progression with 2 or more new metastatic bone lesions on whole-body radionuclide bone scan. 6. The severity of the acute effects of any prior treatment must have resolved to baseline levels or CTCAE = 12 months as assessed by the investigator.
Exclusion criteria
Exclusion criteria: 1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. a. HIV/HBV/HCV testing is not required unless mandated by local health authority. b. Participants with known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness, or active hepatitis B or C are excluded. c. Chronic liver diseases including alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson’s disease, hemochromatosis, alpha-1 antitrypsin deficiency, or other chronic liver disease. 2. Clinically significant cardiovascular disease, defined as: a. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV),cerebrovascular accident, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, clinically important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, atrial fibrillation of any grade. b. Cardiac rhythm device/pacemaker. Participants with cardiac rhythm device/pacemaker must be discussed in detail with sponsor medical monitor to determine eligibility. c. QTcF >480 msec on screening ECG. 3. CNS pathology/neurological findings: a. Known or suspected brain metastasis or active leptomeningeal disease. b. Symptomatic or impending spinal cord compression or cauda equina syndrome. c. Participants with epidural disease, canal disease and prior cord involvement are NOT excluded if those areas have been treated, are stable, and not neurologically impaired. d. Clinically significant history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of unexplained loss of consciousness or transient ischemic attack within 12 months of randomization. 4. Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy except for any of the following: a. Carcinoma in situ or non-melanoma skin cancer. b. Any prior malignancies >=3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage. c. Stage 0 or Stage 1 cancer 10 mg/day (or equivalents) for prostate cancer, with the following exceptions: o Treatment with first-generation antiandrogen (ADT) agents (eg, bicalutamide, nilutamide, and flutamide), but there must be a washout period of 28 days prior to randomization. o Docetaxel treatment is allowed for mCSPC , as long as no s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Image test; | — |
Countries
China
Contacts
Public ContactQiang Wei
West China Hospital of Sichuan University
Outcome results
None listed