Metastatic Castration-resistant Prostate Cancer (mCRPC)
Conditions
Interventions
Experimental group:Pasritamig +Docetaxel
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be greater than or equal to (>=)18 years of age at the time of informed consent or at least the legal age of majority in the jurisdiction in which the study is taking place. 2. Have histologically confirmed adenocarcinoma of the prostate; 3. Have disease that is metastatic at the time of the screening as determined by the investigator; 4. Have progressive disease defined as at least one of the following:a. Prostate-specific antigen (PSA) level >=2 nanogram per milliliter (ng/mL) that has increased on at least 2 successive occasions at least 1 week apart. b. Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera as defined by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 and/or in bone scan per prostate cancer working group 3 (PCWG3) while on medical or surgical castration; 5. Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) throughout the treatment phase or have had prior bilateral orchiectomy and have serum testosterone less than or equal to (=9.0 g/dL, Neutrophils >=1.5×10^9/L, Platelets >=100×10^9/L; Note: Blood transfusions or the use of growth factors are not allowed within 14 days prior to randomization. 11. Agree, while on study treatment and for 6 months after the last dose of study treatment, to: a. Not donate gametes (that is, sperm) or freeze for future use for the purposes of assisted reproduction. b. Wear an external condom, when transmission of sperm or ejaculate can occur. c. If able to produce sperm and their partner is of childbearing potential, the partner must practice a highly effective method of contraception. 12. Participants (or their legally designated representative) must sign an informed consent form (ICF); 13. Be willing and able to adhere to the lifestyle restrictions specified in this protocol.
Exclusion criteria
Exclusion criteria: 1.Known history of either brain or leptomeningeal prostate cancer metastases. 2.Patients with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated. 3.Suspected or known allergies, hypersensitivity, or intolerance to pasritamig excipients or docetaxel excipients; 4.Not recovered from recent surgery; 5.Solid organ or bone marrow transplantation; 6.Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications. 7.Cardiovascular dysfunction within 6 months prior to first dose of study treatment; 8.Prior or concurrent second malignancy (other than the disease under study) because the natural history or treatment could interfere with study endpoints. 9.Received cytotoxic chemotherapy for prostate cancer in any setting; 10.Received prior treatment with human kallikrein 2 (KLK-2)-directed therapies. 11.Received prior treatment for prostate cancer with: a. Cluster of differentiation (CD3) redirector therapies or b. Radiopharmaceutical agents or c. Immunotherapy agents for prostate cancer (for example, sipuleucel-T, programmed cell death protein-1 [PD-1] inhibitors, T-cell redirectors, costimulatory agents.) or d. PARP inhibitors (other than for BRCA1/2 mutation) or e. Any other investigational agent for the treatment of metastatic castrate-resistant prostate cancer (mCRPC); 12.Participants who are human immunodeficiency virus (HIV)-positive. 13.Active hepatitis of infectious origin. a. Seropositive for hepatitis B: defined by a positive test for hepatitis B surface antigen (HBsAg). b. Known hepatitis C infection or positive serologic testing for hepatitis C virus (anti-HCV) antibody. c. Other clinically active liver disease of infectious origin. 14.Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment. Non-live and non-replication-competent vaccines are allowed. 15.Received systemic glucocorticoids (doses >10 milligram per day [mg/day] prednisone or equivalent) within 3 days prior to the first dose of study treatment. 16.Received external beam radiation therapy within 14 days prior to start of study treatment. However, if palliative focal radiation was used, the participant is eligible regardless of date of radiation. 17.Any condition which, in the opinion of the investigator, would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Progression-Free Survival (rPFS) Assessed by BICR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Subsequent Therapy (TST);Time to Skeletal-Related Event (TSRE);Time to Symptomatic Progression (TSP);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactDong Qiang
West China Hospital of Sichuan University
Outcome results
None listed