Approval Probability
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Lu-17-PSMA-617 · 1 trial · 1 indication
Staging of prostate cancer is based on the correlation to Gleason Grade Group (GG) according to the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) staging system for prostate cancer (see Appendix A). Prostate cancer downstaging is defined as the post-treatment stage less than the pre-treatment stage. Different downstaging thresholds will be applied including: * Complete downstaging (CD) is defined as no visible tumor in surgical sample; * Good response (GR) is defined as downstaging from high risk disease (GG4 or greater) to intermediate risk pathologic disease (GG2 or GG3 disease); and * Very good response (VGR) is defined as downstaging from high-risk disease (GG4 or greater) to low risk pathologic disease (GG1 disease).
| Arm | Type | Description |
|---|---|---|
| Lu-177-PSMA-617 Treatment | EXPERIMENTAL | Patients will receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week) |
| Name | Type | Description |
|---|---|---|
| Lu-17-PSMA-617 | DRUG | Lu-17-PSMA-617 administration |
Inclusion Criteria: * Patients age 18 or older. * Patients with histologically confirmed adenocarcinoma of the prostate. * Patients with high-risk disease defined as a preoperative prostate biopsy of Gleason Score 8 (GS8) (Grade group 4 \[GG4\]) or higher. Men with evidence of lymph node involvemen...
Lu-17-PSMA-617 is an investigational small molecule being studied for the treatment of prostate adenocarcinoma. It is currently in a Phase 2 clinical trial as a neoadjuvant therapy for patients with high-risk localized prostate cancer who are undergoing radical prostatectomy. The drug is being evaluated in a single-arm, uncontrolled study.
Lu-17-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 isotope, lutetium-177, directly to the tumor cells. This targeted approach is designed to damage cancer cells while sparing normal tissue. The drug is being investigated in prostate adenocarcinoma.
Lu-17-PSMA-617 is being developed by Meridian Bioscience Inc, a company traded on the stock exchange under the ticker symbol VIVO. The company is conducting a Phase 2 clinical trial to evaluate the drug as a neoadjuvant treatment for high-risk localized prostate cancer.
Lu-17-PSMA-617 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is recruiting patients with high-risk localized prostate cancer to assess the drug's safety and efficacy before radical prostatectomy.
Lu-17-PSMA-617 is being studied in one active clinical trial, identified as NCT06798558. This Phase 2 trial is titled 'Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy.' The study is recruiting 54 male patients aged 18 years and older in the United States, and it is not randomized or blinded.
Lu-17-PSMA-617 is the drug name used in the clinical trial record, while the trial title refers to the same compound as Lu-177-PSMA-617. Both names denote the same investigational small molecule being developed by Meridian Bioscience Inc for prostate adenocarcinoma. The drug is a PSMA-targeted radioligand therapy.