Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

Launched by AMGEN · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called xaluritamig for men who have a specific type of prostate cancer known as high-risk biochemical recurrent non-metastatic castrate-sensitive prostate cancer. The main goal is to see how safe this treatment is and how well it is tolerated by participants. Men aged 65 to 74 who have already received treatment for their prostate cancer, such as surgery or radiation, may be eligible. To qualify, they must have rising prostate-specific antigen (PSA) levels that indicate their cancer has returned, along with certain other health criteria.

If a participant joins the study, they will receive xaluritamig and will be monitored for any side effects or reactions to the treatment. This study is currently looking for volunteers, and it’s important for potential participants to discuss the details with their doctors to determine if they meet the eligibility requirements. Overall, this trial aims to find a new option for men whose prostate cancer has returned after initial treatment, and it may contribute valuable information about managing this condition.

Gender

MALE

Eligibility criteria

• • Inclusion Criteria
• • Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features.
• • Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent.
• • PSA doubling time ≤ 12 months.
• • Participants must have biochemically recurrent disease after definitive treatment to prostate by either RP or XRT.
• • Screening PSA by the local laboratory ≥ 0.2 ng/mL for participants who had RP (with or without XRT) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir (local assessments) for participants who had XRT or brachytherapy only as primary treatment for prostate cancer.
• • Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).
• • Participants must have undergone a 68Ga-PSMA-11 or a piflufolastat F18 PET scan during or within 3 months of screening.
• • Exclusion Criteria
• • Present evidence of metastatic disease in conventional CT scan and/or bone scan
• • Participants that present prostate-specific membrane antigen (PSMA)-positive lesions in the 68Ga-PSMA-11 or the piflufolastat F18 positron emission tomography (PET) scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease.
• * Prior hormonal therapy, exceptions include:
• • Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or
• • A single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before enrollment.
• • Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, enzalutamide, apalutamide, or darolutamide for prostate cancer.
• • Abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment.
• • Prior systemic biologic therapy, including immunotherapy, for prostate cancer.
• • If, in the investigator's opinion, salvage therapy is the preferred intervention.
• • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
• • Participant 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.
• • Requirement for chronic systemic corticosteroid therapy (prednisone dose \> 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha \[TNFα\] therapies).