Castration-Resistant Prostate Cancer
Conditions
Interventions
*Drug: PF-06821497
-Oral continuous
-Other Names:
#Mevrometostat
*Drug: Placebo
-Oral continuous
*Drug: Enzalutamide
-Oral continuous
-Other Names:
#Xtandi
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *Male participants aged >=18 years (or the minimum age of consent in accordance with local regulations) at screening. *Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. *Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan. *Surgically or medically castrated, with serum testosterone =12 months as assessed by the investigator.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: *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. *Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery. *Clinically significant cardiovascular disease. *Known or suspected brain metastasis or active leptomeningeal disease. *Participants must be treatment naive at the mCRPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents and. Docetaxel treatment is allowed for mCSPC. *Previous administration with an investigational product (drug or vaccine) within 30 days. *Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study). *Major surgery or palliative localized radiation therapy within 14 days before randomization. *Inadequate organ function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Radiographic Progression Free Survival (rPFS) [Time Frame: Randomization up to approximately 3 years] -rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Overall survival (OS) [Time Frame: Randomization up to approximately 5 years] -OS is defined as the time from the date of randomization to the date of death due to any cause. *To demonstrate that PF-06821497 in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging TTPP [Time Frame: Randomization up to approximately 3 years] -TTPP (alpha protected): assessed using time to first >=2-point increase from baseline score on BPI-SF Item 3 (Worst Pain) observed at 2 consecutive visits or the initiation of short- or long-acting opioid use for pain *Duration of Response (DoR) in measurable soft tissue disease [Time Frame: Randomization up to approximately 3 years.] -The DoR is defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause whichever occurs first. *Time to prostate specific antigen (PSA) progression. [Time Frame: Randomization up to approximately 3 years] -Time from the date of randomization to the date of the first PSA progression. PSA progression is defined as a >=25% increase in PSA with an absolute increase of >=2 ng/mL above the nadir (or baseline for participants with no PSA decline), confirmed by a second consecutive PSA value at least 21 days later. *Prostate Specific Antigen Response [Time Frame: Randomization up to approximately 3 years.] -Proportion of participants with PSA response >=50% in participants with detectable PSA values at baseline. *Time to initiation of antineoplastic therapy. [Time Frame: Randomization up to approximately 3 years.] -Time from randomization to first use of new antineoplastic therapy. *Time to initiation of cytotoxic chemotherapy. [Time Frame: Randomization up to approximately 3 years] -Time from randomization to first use of new cytotoxic chemotherapy. *Time to first symptomatic skeletal event [Time Frame: Randomization up to approximately 3 years.] -Time from randomization | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed