Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
177Lu-PMSA-617 · 1 trial · 1 indication
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.
Radiographic progression-free survival (rPFS) is defined as the time from randomization to the date of radiographic progression according to PCWG3 criteria by investigator assessment, or death, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm A (Control arm): Standard of Care (SoC) alone | ACTIVE_COMPARATOR | The SoC is defined as one the following treatment which was initiated 6 to 8 months ahead of inclusion in this trial and still ongoing at the time of the randomization and continued at least until the CRPC stage is reached.: * ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapyª * ADT with docetaxelᵇ plus an ARSI (i.e. abiraterone + prednisone, or darolutamide,) ± radiotherapyª ª Radiotherapy can be part of any standard treatment aforementioned as long as it is not PSMA-based and completed at least 4 weeks ahead of randomization OR planned right after randomization in arm A. ᵇ Whenever docetaxel was part of the systemic treatment initiation, its administration must have been completed at least 4 weeks ahead of randomization. |
| Arm B (Experimental arm): 177Lu-PMSA-617 + SoC | EXPERIMENTAL | Once every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles. Upon 177Lu-PMSA-617 treatment completion, the ongoing standard systemic treatment is to be maintained and continued at least until the CRPC stage is reached. The SoC is defined as one the following treatment which was initiated 6 to 8 months ahead of inclusion in this trial and still ongoing at the time of the randomization: * ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapyª * ADT with docetaxelᵇ plus an ARSI (i.e. abiraterone + prednisone, or darolutamide,) ± radiotherapyª ª Radiotherapy can be part of any standard treatment aforementioned as long as it is not PSMA-based completed at least 4 weeks ahead of randomization OR planned right after 177Lu-PSMA-617 in arm B. ᵇ Whenever docetaxel was part of the systemic treatment initiation, its administration must have been completed at least 4 weeks ahead of randomization. |
| Name | Type | Description |
|---|---|---|
| 177Lu-PMSA-617 | DRUG | Once every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles. |
| Standard of Care | DRUG | ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care |
Inclusion Criteria: All of the following criteria must be met ahead of randomization to satisfy trial eligibility requirements: 1. Signed a written informed consent form prior to any trial specific procedures. Note: In case of physical incapacitation, a trusted representative of their choice, ...
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177Lu-PSMA-617 is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is currently in Phase 3 clinical development, specifically evaluated in patients with de novo metastatic hormone-sensitive prostate cancer who have a poor PSA response to standard of care.
177Lu-PSMA-617 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase 3 clinical trial to evaluate the drug in metastatic prostate cancer.
177Lu-PSMA-617 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to assess its efficacy and safety in metastatic prostate cancer.
177Lu-PSMA-617 is being evaluated in a Phase 3 clinical trial registered as NCT06496581, titled 'Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)'. The trial is recruiting 500 male patients aged 18 years and older in France.
177Lu-PSMA-617 is the drug name used in clinical development. No alternative names have been established for this investigational agent. It is being studied under this designation in the ongoing Phase 3 trial for metastatic prostate cancer.
177Lu-PSMA-617 is a small molecule designed to target prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. By binding to PSMA, the drug delivers a radioactive payload to cancer cells, potentially causing targeted cell death while sparing normal tissues.