Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
177Lu-PSMA-617 · 1 trial · 1 indication
Undetectable PSA is defined as PSA ≤ 0.2ng/ml at 12 months after protocol treatment commencement. Patients who experience unequivocal radiographic (by conventional imaging modality) and/or clinical disease progression within 12 months of initiating protocol treatment will be considered as not having undetectable PSA at 12 months.
| Arm | Type | Description |
|---|---|---|
| 177Lu-PSMA+ Docetaxel | EXPERIMENTAL | 7.5 GBq (± 10%) 177Lu-PSMA every 6 weeks x 2 cycles. Docetaxel 75 mg/m2 commencing 6 weeks later, every 3 weeks x 6 cycles |
| Docetaxel (Control) | OTHER | Docetaxel 75 mg/m2 every 3 weeks x 6 cycles |
| Name | Type | Description |
|---|---|---|
| 177Lu-PSMA-617 | DRUG | Patients will be given 7.5GBq of 177Lu-PSMA every 6 weeks for 2 cycles. |
| Docetaxel | DRUG | Docetaxel 75 mg/m2 given every 3 weeks for 6 cycles |
Inclusion Criteria for study registration: 1. Patient has provided written informed consent 2. Male aged 18 years or older at screening 3. Prostate cancer diagnosed within 12 weeks of commencement of screening 4. Histologically or cytologically confirmed adenocarcinoma of the prostate without signi...
177Lu-PSMA-617 is an investigational small molecule being studied for the treatment of Metastatic Hormone Naive Prostate Cancer. It is a radionuclide therapy that delivers radiation to prostate-specific membrane antigen (PSMA) expressing cells. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
177Lu-PSMA-617 targets prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. By binding to PSMA, the drug delivers a radioactive payload (Lutetium-177) directly to the tumor cells, potentially causing cell death while sparing normal tissues. This targeted approach is being evaluated in metastatic hormone naive prostate cancer.
177Lu-PSMA-617 is being developed by Pulmonx Corporation, a company traded on the NASDAQ under the ticker symbol LUNG. The company is conducting a Phase 2 clinical trial to evaluate the safety and benefit of this radionuclide treatment in men with metastatic prostate cancer.
177Lu-PSMA-617 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is active but not recruiting participants, and it is designed to assess the safety and efficacy of the treatment in metastatic hormone naive prostate cancer.
177Lu-PSMA-617 is being studied in one active Phase 2 clinical trial with the identifier NCT04343885. The trial, titled 'In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy,' is enrolling 130 male participants aged 18 years and older in Australia. The study is randomized and controlled, but not double-blinded.