A Phase 1/2 Open-label, Multi-center, Dose-escalation Study of Safety, Tolerability, Pharmacokinetics, Dosimetry, and Response to Repeat Dosing of 177Lu-PSMA-R2 Radio-ligand Therapy in Patients With Prostate Specific Membrane Antigen (PSMA) Positive (68Ga-PSMA-R2) Progressive Metastatic Castration-resistant Prostate Cancer, Following Previous Systemic Treatment
Phase of Trial: Phase I/II
Latest Information Update: 14 Nov 2019
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At a glance
- Drugs Lutetium 177 PSMA R2 (Primary) ; Gallium 68 PSMA R2
- Indications Adenocarcinoma; Prostate cancer
- Focus Adverse reactions; First in man; Therapeutic Use
- Acronyms PROter
- Sponsors Advanced Accelerator Applications
- 13 Nov 2019 Planned number of patients changed from 96 to 110.
- 06 Jun 2019 Number of arms changed from 4 to 7. Three more cohorts added to Dose escalation phase. Pharmacokinetic end points removed from primary end points.
- 05 Feb 2019 Status changed from active, no longer recruiting to recruiting.