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177Lu-PSMA

DRUG5 trials

Sponsors

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, Peter MacCallum Cancer Centre, Australia

Conditions

68Ga-PSMA PET/CT PositiveMetastatic Castration Resistant Prostate CancerMetastatic Castration Resistant Prostate Cancer (mCRPC)Metastatic Castration-resistant Prostate CancerOligometastatic Prostate CancerProstate Cancer

Phase 1

PRINCE (PSMA-lutetium Radionuclide Therapy and ImmuNotherapy in Prostate CancEr)
CompletedNCT03658447
Peter MacCallum Cancer Centre, AustraliaMetastatic Castration Resistant Prostate Cancer
Start: 2019-07-12End: 2022-12-22Updated: 2023-07-28
177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer
Active, not recruitingNCT03874884
Peter MacCallum Cancer Centre, AustraliaMetastatic Castration Resistant Prostate Cancer (mCRPC)
Start: 2019-07-09End: 2026-06-30Target: 70Updated: 2025-05-14

Phase 2

Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC)
CompletedNCT03454750
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS68Ga-PSMA PET/CT Positive, Metastatic Castration Resistant Prostate Cancer
Start: 2022-10-25End: 2024-05-22Updated: 2025-01-08
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
RecruitingNCT05560659
Peter MacCallum Cancer Centre, AustraliaOligometastatic Prostate Cancer
Start: 2023-12-14End: 2027-05-31Target: 92Updated: 2025-07-11

Unknown Phase

ProsTIC Registry of Men Treated With PSMA Theranostics
Active, not recruitingNCT04769817
Peter MacCallum Cancer Centre, AustraliaMetastatic Castration-resistant Prostate Cancer, Prostate Cancer
Start: 2021-05-19End: 2028-12-31Target: 500Updated: 2026-05-14

Related Papers

Prognostic Value of Restaging [ <sup>18</sup> F]FDG PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer Undergoing [ <sup>177</sup> Lu]Lu-PSMA-617 Therapy
Journal of Nuclear Medicine2026-06-25
Prognostic Value of Initial Imaging and PSA Change with [&lt;sup&gt;177&lt;/sup&gt;Lu]Lu-PSMA-617 Radiopharmaceutical Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer: A ProsTIC Registry Analysis.
2025-12-031 citations
Prognostic Value of Posttherapy SPECT/CT for Overall Survival in Patients Undergoing [<sup>177</sup>Lu]Lu-PSMA-617 Radiopharmaceutical Therapy: Results from 3 Clinical Trials
Journal of Nuclear Medicine2025-07-033 citations
LuPARP: Phase 1 trial of 177Lu-PSMA-617 and olaparib in patients with metastatic castration resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2023-06-0162 citations
Circulating tumor cells (CTCs) in patients with metastatic castration resistant prostate cancer (mCRPC) treated with olaparib plus <sup>177</sup>lutetium-prostate specific membrane antigen-617 (<sup>177</sup>Lu-PSMA-617) in the LuPARP trial.
Journal of Clinical Oncology2023-06-011 citations
Abstract 5614: Genomic aberrations in circulating tumor DNA (ctDNA) and clinical outcomes from [177Lu]Lu-PSMA-617 in metastatic castration-resistant prostate cancer (mCRPC)
Cancer Research2023-04-043 citations
PRINCE: Phase I trial of <sup>177</sup>Lu-PSMA-617 in combination with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2022-06-0152 citations
Circulating tumour cells (CTCs) and PSMA PET correlates in the phase I PRINCE trial of <sup>177</sup>Lu-PSMA-617 plus pembrolizumab for metastatic castration resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2022-06-013 citations
Circulating androgen receptor gene amplification and resistance to <sup>177</sup>Lu-PSMA-617 in metastatic castration-resistant prostate cancer: results of a Phase 2 trial.
2021-07-3122 citations
Dosimetry and safety of <sup>177</sup>Lu PSMA-617 along with polyglutamate parotid gland protector: preliminary results in metastatic castration-resistant prostate cancer patients.
2020-05-2046 citations
Circulating androgen receptor (AR) gene amplification and resistance to 177Lu-PSMA-617 in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Results of a phase II clinical trial.
Journal of Clinical Oncology2019-05-203 citations