Floatz Rating
B63/100
Confidence
Indicative
Sponsor
Mayo Clinic
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
66High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07650240CT.gov Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial | — | Not Yet Recruiting | — | — | — |
NCT07550517CT.gov PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT | — | Not Yet Recruiting | — | — | — |
NCT07200830CT.gov Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial | — | Recruiting | — | — | — |
NCT07145177CT.gov 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer | — | Recruiting | — | — | — |
NCT07219147CT.gov 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer | — | Recruiting | — | — | — |
NCT06972628CT.gov Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617 | — | Recruiting | — | — | — |
NCT06574880CT.gov STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer | — | Recruiting | — | — | — |
NCT06526299CT.gov Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease | — | Recruiting | — | — | — |
NCT06632977CT.gov Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial | — | Recruiting | — | — | — |
NCT06449781CT.gov 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer | — | Recruiting | — | — | — |
Show 23 more trialsShow fewer
NCT06145633CT.gov Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer | — | Recruiting | — | — | — |
NCT06288113CT.gov Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial | — | Recruiting | — | — | — |
NCT06216249CT.gov Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) | — | Recruiting | — | — | — |
NCT06303713CT.gov LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT06200103CT.gov Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer | — | Recruiting | — | — | — |
NCT05939414CT.gov An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. | — | Recruiting | — | — | — |
NCT05766371CT.gov Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer | — | Recruiting | — | — | — |
NCT06084338CT.gov Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc | — | Recruiting | — | — | — |
NCT05803941CT.gov Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer | — | Recruiting | — | — | — |
NCT05818683CT.gov A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer | — | Recruiting | — | — | — |
NCT05340374CT.gov Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT05113537CT.gov Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer | — | Recruiting | — | — | — |
NCT05150236CT.gov EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC | — | Unknown | — | — | — |
NCT05079698CT.gov A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT04663997CT.gov 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT04886986CT.gov Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer | — | Recruiting | — | — | — |
NCT04443062CT.gov Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer | — | Completed | — | — | — |
NCT03606837CT.gov 68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Intermediate Risk Prostate Cancer Imaging | — | Completed | — | — | — |
NCT03805594CT.gov 177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer | — | Completed | — | — | — |
NCT03511664CT.gov Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer | — | Completed | — | — | — |
NCT03604757CT.gov 68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Prostate Cancer Imaging According to Various Metastatic Risks | — | Completed | — | — | — |
NCT03545165CT.gov 177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC | — | Terminated | — | — | — |
NCT03042468CT.gov Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC | — | Active Not Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Prostate Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Vipivotide Tetraxetan (this asset) | Mayo Clinic | Approved | B · 63 |
| Avodart | Bay State Clinical Trials, Inc. | P4 | BBB |
| Desflurane | Peter MacCallum Cancer Centre, Australia | P4 | BBB |
| Propofol | Peter MacCallum Cancer Centre, Australia | P4 | BBB |
| Degarelix | Bayer | P4 | BBB |
| Flotufolastat F 18 | Washington University School of Medicine | P4 | BB |
| AVOLVE | Masonic Cancer Center, University of Minnesota | P4 | BB |
| Estramustine | The University of Texas Health Science Center, Houston | P3 | BB |
| Pasireotide | RECORDATI GROUP | P4 | BB |
+42 more in the Prostate Cancer cohort
Other indications for Vipivotide Tetraxetan
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Prostate Adenocarcinoma | — | P3 | BB · 67 |
| Renal Cell Carcinoma | — | P3 | BB · 66 |
| Prostate Carcinoma | — | P2 | BB · 64 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Vipivotide Tetraxetan in Prostate Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/vipivotide-tetraxetan-prostate-cancer-115222
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