Metastatic castration-resistant prostate cancer (mCRPC) Cancer
Conditions
Interventions
Pasritamig + Docetaxel Arm:
Participants will receive two step-up doses of pasritamig followed by the target dose every 6 weeks by IV administration. Docetaxel will be administered every 3 weeks up to
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Be 18 years of age or older at the time of informed consent. 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 per the trial protocol) 5. Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analogue (agonist or antagonist) throughout the Treatment Phase or have had prior bilateral orchiectomy and have serum testosterone lower than or equal to50 ng/dL at screening. 6. Have progressed on at least one novel androgen receptor pathway inhibition (ARPI) treatment but received no more than two different ARPI for any stage of disease. Must have discontinued ARPI before randomisation into the study. 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 8. Have an estimated glomerular filtration rate (eGFR) of more than 30 mL/min during the screening period. Participants with obstructive uropathy should have treatment prior to randomisation (e.g., foley catheter, nephrostomy tubes, etc). 9. Have the protocol specified laboratory values for hepatic function during the screening period. 10. Have the protocol specified hematologic laboratory values during the screening period. 13. Agree (while on study treatment and for 6 months after the last dose of study treatment) to not donate gametes (i.e., sperm) or freeze for future use for the purposes of assisted reproduction, and to wear an external condom when transmission of sperm/ejaculate can occur. If able to produce sperm and their partner is of childbearing potential, the partner must practice a highly effective method of contraception. 14. Participant (or their legally designated representative) must sign an informed consent form. 15. 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 (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 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. Any of the protocol specified cardiac conditions 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 any protocol specified therapies. 12. Participants who are HIV-positive and meet any of the protocol specified criteria. 13. Active hepatitis 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 greater than 10 mg/day prednisone or equivalent) within 3 days prior to the first dose of study treatment. A single course of glucocorticoids is permitted as prophylaxis for imaging contrast. If glucocorticoids were used to treat immune-related adverse events associated with prior therapy, at least 7 or more days must have elapsed since the last dose of corticosteroid 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 (e.g., 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): blinded independent central review (BICR) assessed per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 and Prostate Cancer Working Group 3 (PCWG3). The primary endpoint is defined as the time from the date of randomisation to the first date of radiographic disease progression, or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key: 1. Overall survival (OS): time from the date of randomisation to the date of death due to any cause 2. Time to symptomatic progression (TSP): time from the date of randomisation to the date of first occurrence of any of the protocol-specified criteria 3. Time to subsequent therapy (TST): time from randomisation to the initiation of any subsequent systemic anticancer therapy 4. Time to skeletal-related event (TSRE): time from the date of randomisation to the date of first occurrence of any of the protocol-specified criteria Other: 1. Objective response rate: the proportion of participants who have measurable disease at baseline and have complete response (CR) or partial response (PR) by objective radiographic disease evaluation per RECIST v1.1, and no bone progression per PCWG3 as determined by the BICR, assessed every 8 weeks until disease progression or death. 2. Duration of response (DOR): DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first. 3. Time to prostate-specific antigen (PSA) progression: time from randomization to the first date of documented PSA progression per PCWG3 criteria. 4. PSA response; reported as PSA50 and PSA90 response: the proportion of participants with a reduction in blood concentration of PSA (ng/mL) to 50%/90% from baseline, confirmed by a second value at least 3 weeks apart, measured at each protocol-defined visit until progression. 5. Duration of PSA response: time from the date of documented PSA50 response to the date of documented PSA Progression. 6. Progression-free survival on subsequent therapy (PFS2) is defined as the time from randomization to the date of progression (radiographic, clinical, or PSA progression) on the first subsequent anti-cancer (second progression), or death | — |
Countries
Australia, Belgium, Brazil, Canada, China, England, France, Germany, Italy, Japan, Malaysia, Scotland, Spain, Taiwan, United Kingdom, Wales
Contacts
Public ContactPeter Chatfield
Outcome results
None listed