Therapy Detail
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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). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| 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). |
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| 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 |
|---|---|---|---|---|---|---|
| NCT03511664 | Phase III | lutetium Lu 177 vipivotide tetraxetan | Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION) | Active, not recruiting | USA | FRA | DEU | CAN | BEL | 5 |
| NCT05204927 | Phase III | Abiraterone + Enzalutamide lutetium Lu 177 vipivotide tetraxetan Abiraterone + Prednisone | Lu-177-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer | Recruiting | USA | ITA | FRA | ESP | 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 |
| 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 | FRA | ESP | DEU | CAN | BEL | AUT | 7 |
| NCT04663997 | Phase II | Docetaxel lutetium Lu 177 vipivotide tetraxetan | 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer | Recruiting | CAN | 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) | Recruiting | USA | FRA | ESP | DEU | CAN | BEL | AUT | 14 |
| 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 |
| 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 | 1 | |
| 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) | Recruiting | 1 |
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