Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Launched by AMGEN · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called xaluritamig for men with localized prostate cancer who are planning to have surgery to remove their prostate, known as radical prostatectomy. The main goals are to see how safe this treatment is and if it can be tolerated before surgery. The trial is currently looking for male participants aged 65 to 74 who have been diagnosed with a specific type of prostate cancer that is either intermediate or high-risk, based on certain medical tests.

To be eligible for this study, participants must not have received prior treatment for their prostate cancer and should have no signs of cancer spreading to other parts of the body. They should also have a certain level of health, measured by a performance status scale. If you or a loved one is considering joining this trial, you can expect to undergo xaluritamig treatment before surgery and will be closely monitored for safety and any side effects. This trial is important because it could help find better ways to treat prostate cancer before surgery, potentially improving outcomes for patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• Participants are eligible to be included in the study only if all the following criteria apply:
• • Participants 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 initial PSA (iPSA) \>10 OR
• • Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND/OR
• • Positive locoregional lymph nodes as detected by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans OR equal or ≤ 5 local lymph nodes on MRI can be enrolled.
• • Participants must have undergone a PSMA-PET (CT or MRI) scan within 3 months prior to screening as part of the standard of care (SOC).
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Exclusion Criteria:
• Participants are excluded from the study if any of the following criteria apply:
• • Prior treatment for participant'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.
• * Participants 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:
• • Participant has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.
• • Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3 months prior to the first dose of study treatment, respectively. Note: Participants with a history of venous thrombosis must be on stable anti-coagulation.
• • 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 unless stopped (with adequate tapering) within 7 days prior to dosing.
• • 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.