癌研連線CancerLink
招募中 NCT06855277

在PSMA阳性的mCRPC成人参与者中比较AAA817 + ARPI与治疗标准的研究

前列腺癌神经内分泌肿瘤Phase IIIIII 期IV 期HRDPSMA

本研究的目的是确定\ [225Ac\] Ac-PSMA-617 (AAA817)在10 Megabecquerel (MBq) +/- 10%的剂量下给予最多6个周期，加上雄激素受体途径抑制剂(ARPI) ，与研究者选择的标准护理(SOC) (ARPI变化或紫杉烷基化疗或\ [177Lu\] Lu-PSMA-617 (AAA617))相比，在患有PSMA阳性转移性去势的成人参与者中，能否改善无放射线影像学进展生存期(rPFS)

适应症：Prostate Cancer

入组条件

纳入标准

  • 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.

排除标准

  • 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.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。