癌研連線CancerLink
招募中 NCT06855277

在PSMA陽性的mCRPC成人參與者中比較AAA817 + ARPI與治療標準的研究

前列腺癌神經內分泌腫瘤Phase IIIIII 期IV 期HRDPSMA

本研究的目的是確定\ [225Ac\] Ac-PSMA-617 (AAA817)在10 Megabecquerel (MBq) +/- 10%的劑量下給予最多6個週期，加上雄激素受體途徑抑制劑(ARPI) ，與研究者選擇的標準護理(SOC) (ARPI變化或紫杉烷基化療或\ [177Lu\] Lu-PSMA-617 (AAA617))相比，在患有PSMA陽性轉移性去勢的成人參與者中，能否改善無放射線影像學進展生存期(rPFS)

適應症：Prostate Cancer

收案條件

納入條件

  • Signed informed consent must be obtained prior to participation in the study.
  • Participants must be adults ≥ 18 years of age.
  • Participants must have an ECOG performance status of 0 to 2.
  • Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
  • Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.
  • Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
  • Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.
  • Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).
  • Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.

排除條件

  • Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \[177Lu\]Lu-PSMA, \[177Lu\]-DOTA, or Radium- 223.)
  • Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).
  • Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.
  • Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.

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。