drugset / Trial / NCT06798558
Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
Phase 2
Recruiting
54 enrolled
Hackensack Meridian Health
Lombardi Comprehensive Cancer Center · collabNovartis · collab
NaSingle-groupOpen-labelTreatment
Summary
Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 \[GG4\]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.
Timeline
- Start
- 2025-03-05
- Primary completion
- 2029-03
- Completion
- 2029-03
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-PSMA-617 | Other / unclassified | 7400 mbq | — |