這是一項II/III期研究。 患者羣體是患有PSMA陽性mCRPC的成年參與者，他們接受了雄激素受體途徑抑制劑（ ARPI ）和紫杉烷基化療的治療，並在\ [177Lu\] Lu-PSMA靶向治療或之後進展。 感興趣的治療：無論隨後的抗腫瘤治療如何，研究治療均為AAA817。
適應症：Prostate Cancer
收案條件
納入條件
- adults ≥ 18 years of age.
- ECOG performance status of 0 to 2.
- histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
- PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
- castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
- Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after \[177Lu\]Lu-PSMA targeted therapy.
- ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
- eGFR as requested by the sponsor
排除條件
- Any investigational agents within 28 days prior to the day of randomization.
- Any 225Ac-based investigational compound used prior to the day of randomization.
- Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
- Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
- Baseline xerostomia ≥ Grade 2 by CTCAE v.5
- History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 2 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。