Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer

Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.

开始日期2020-07-31

申办/合作机构

The Jewish General Hospital

100 项与 131I-PSMA-1095 相关的临床结果

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100 项与 131I-PSMA-1095 相关的转化医学

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100 项与 131I-PSMA-1095 相关的专利（医药）

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项与 131I-PSMA-1095 相关的文献（医药）

2024-08-01·Nuclear Medicine Communications

A phase 2, single-arm trial evaluating 131I-PSMA-1095 targeted radioligand therapy for metastatic castration-resistant prostate cancer

Article

作者: Fallah, Parvaneh ; Mamo, Aline ; Ferrario, Cristiano ; Labidi, Soumaya ; Probst, Stephan M. ; Rose, April A.N. ; Liu, Richard F.

BackgroundMetastatic castration-resistant prostate cancer (mCRPC) remains uniformly lethal. Prostate specific membrane antigen (PSMA) is a transmembrane glycoprotein overexpressed in prostate cancer. 131I-PSMA-1095 (also known as 131I-MIP-1095) is a PSMA-targeted radioligand which selectively delivers therapeutic radiation to cancer cells and the tumor microenvironment.MethodsWe conducted a single-arm, phase 2 trial to assess efficacy and tolerability of 131I-PSMA-1095 in mCRPC patients who had exhausted all lines of approved therapy. All patients underwent 18F-DCFPyL PET and 18F-FDG PET to determine PSMA-positive tumor volume, and patients with >50% PSMA-positive tumor volume were treated with up to four doses of 131I-PSMA-1095. The primary endpoint was the response rate of prostate specific antigen (PSA). Secondary endpoints included rates of radiographic response and adverse events. Overall and radiographic progression-free survival were also analyzed.ResultsEleven patients were screened for inclusion and nine patients received 131I-PSMA-1095. The median baseline PSA was 162 µg/l, and six patients demonstrated a >50% PSA decrease. One patient demonstrated a confirmed radiographic response. Median overall survival was 10.3 months, and median progression-free survival was 5.4 months. Four patients experienced adverse events of grade 3 or higher, the most frequent being thrombocytopenia and anemia.Conclusion131I-PSMA-1095 is highly active against heavily-pretreated PSMA-positive mCRPC, significantly decreasing tumor burden as measured by PSA. Adverse events, mainly hematologic toxicity, were not infrequent, likely related to off-target irradiation. This hematologic toxicity, as well as a higher logistical burden associated with use, could represent relative disadvantages of 131I-PSMA-1095 compared to 177Lu-PSMA-617.

100 项与 131I-PSMA-1095 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
前列腺腺癌	临床2期	加拿大	The Jewish General Hospital	2020-07-31
去势抵抗性前列腺癌	临床2期	加拿大	The Jewish General Hospital	2020-07-31
转移性前列腺癌	临床2期	加拿大	The Jewish General Hospital	2020-07-31