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Therapy Name | lutetium Lu 177 vipivotide tetraxetan |
Synonyms | |
Therapy Description |
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioconjugate comprising a prostate-specific membrane antigen (PSMA) inhibitor radiolabeled with Lu177, which targets PSMA expressing cells, potentially resulting in decreased tumor growth (PMID: 25883127, PMID: 26795286, PMID: 32760622). Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is FDA approved for use in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor (AR) pathway inhibition and taxane-based chemotherapy (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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lutetium Lu 177 vipivotide tetraxetan | Pluvicto | Lu177-PSMA-617|Vipivotide tetraxetan Lu-177 | Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioconjugate comprising a prostate-specific membrane antigen (PSMA) inhibitor radiolabeled with Lu177, which targets PSMA expressing cells, potentially resulting in decreased tumor growth (PMID: 25883127, PMID: 26795286, PMID: 32760622). Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is FDA approved for use in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor (AR) pathway inhibition and taxane-based chemotherapy (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT04663997 | Phase II | Docetaxel lutetium Lu 177 vipivotide tetraxetan | 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer | Active, not recruiting | CAN | 0 |
NCT06574880 | Phase Ib/II | lutetium Lu 177 vipivotide tetraxetan | STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer (STARLiT) | Not yet recruiting | USA | 0 |
NCT05079698 | Phase I | lutetium Lu 177 vipivotide tetraxetan | A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer | Active, not recruiting | USA | 0 |
NCT06145633 | Phase II | lutetium Lu 177 vipivotide tetraxetan Vorinostat | Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer | Recruiting | USA | 0 |
NCT06288113 | Phase II | lutetium Lu 177 vipivotide tetraxetan | Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial | Recruiting | USA | 0 |
NCT05204927 | Phase III | Abiraterone + Enzalutamide lutetium Lu 177 vipivotide tetraxetan Abiraterone + Prednisone | Lu-177-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer | Active, not recruiting | USA | ITA | FRA | ESP | 0 |
NCT05682443 | Phase II | lutetium Lu 177 vipivotide tetraxetan + ONC-392 lutetium Lu 177 vipivotide tetraxetan | ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (PRESERVE-006) | Recruiting | USA | 0 |
NCT05150236 | Phase II | Ipilimumab + lutetium Lu 177 vipivotide tetraxetan + Nivolumab lutetium Lu 177 vipivotide tetraxetan Nivolumab | 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC (EVOLUTION) (EVOLUTION) | Active, not recruiting | AUS | 0 |
NCT06526299 | Phase II | lutetium Lu 177 vipivotide tetraxetan | Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease | Not yet recruiting | USA | 0 |
NCT06216249 | Phase II | lutetium Lu 177 vipivotide tetraxetan | Evaluation of a Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer | Recruiting | USA | 0 |
NCT06200103 | FDA approved | lutetium Lu 177 vipivotide tetraxetan | Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer | Recruiting | USA | 0 |
NCT04689828 | Phase III | lutetium Lu 177 vipivotide tetraxetan | 177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer | Active, not recruiting | USA | SWE | SVK | POL | NLD | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUT | 0 |
NCT04443062 | Phase II | lutetium Lu 177 vipivotide tetraxetan | Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer (Bullseye) | Active, not recruiting | NLD | CYP | 0 |
NCT04720157 | Phase III | lutetium Lu 177 vipivotide tetraxetan | An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition) | Active, not recruiting | USA | SWE | POL | NLD | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BEL | AUT | 5 |
NCT06388369 | Phase Ib/II | lutetium Lu 177 vipivotide tetraxetan Ipilimumab + lutetium Lu 177 vipivotide tetraxetan | Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer (NEPI) | Not yet recruiting | DEU | 0 |
NCT04430192 | Phase Ib/II | lutetium Lu 177 vipivotide tetraxetan | Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy (LuTectomy) | Active, not recruiting | AUS | 0 |
NCT03042468 | Phase I | lutetium Lu 177 vipivotide tetraxetan | Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC | Active, not recruiting | USA | 0 |
NCT03511664 | Phase III | lutetium Lu 177 vipivotide tetraxetan | Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION) | Completed | USA | SWE | NLD | GBR | FRA | DNK | DEU | CAN | BEL | 1 |
NCT06084338 | Phase II | lutetium Lu 177 vipivotide tetraxetan + Testosterone lutetium Lu 177 vipivotide tetraxetan | Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc | Recruiting | USA | 0 |
NCT05849298 | Phase II | lutetium Lu 177 vipivotide tetraxetan Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + lutetium Lu 177 vipivotide tetraxetan Apalutamide + lutetium Lu 177 vipivotide tetraxetan | A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (PSMACare) | Recruiting | USA | POL | NLD | ITA | FRA | ESP | CZE | CAN | 3 |