Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Eligibility Criteria

Inclusion Criteria:

Subjects are eligible to be included in the study only if all the following criteria apply:

* Subjects planned to undergo radical prostatectomy.
* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. Intermediate- or high-risk localized prostate cancer, defined as:
* Gleason score of 4+3 or higher AND iPSA >10 OR
* Clinically advanced (cT3) on MRI imaging obtained within 3 months prior to screening AND/OR
* Positive locoregional lymph nodes as detected by PSMA-PET scans OR equal or ≤ 5 local lymph nodes on MRI can be enrolled.
* Subjects must have undergone a gallium-68 prostate-specific membrane antigen (68Ga-PSMA-11) or a piflufolastat F 18 PET (CT or MRI) scan within 3 months prior to screening as part of the SOC.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

* Prior treatment for subject's prostate cancer.
* Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans.
* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
* Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment:
* Subject has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the subject may be considered eligible for the study from an infection standpoint.
* History of arterial or venous thrombosis or other diseases requiring permanent anticoagulation (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis):
* Patients requiring anticoagulation due to atrial fibrillation may be allowed if they can safely stop the anticoagulation for the perisurgical timeframe.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association ≥ class II) within 12 months of first dose of xaluritamig with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement more than 6 months prior to first dose of xaluritamig.
* Requirement for chronic systemic corticosteroid therapy
* Currently receiving treatment in another investigational device or drug study, or less than 4 weeks (since ending treatment on another investigational device or drug study[ies]). Other investigational procedures and participation in observational research studies while participating in this study are excluded with the exception of investigational scans.