An International, Prospective, Open-Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 for the Treatment of Patients with Progressive Prostate Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase of Trial: Phase III
Latest Information Update: 26 Feb 2018
At a glance
- Drugs PSMA 617 (Primary)
- Indications Prostate cancer
- Focus Registrational; Therapeutic Use
- Acronyms VISION
- Sponsors Endocyte
- 26 Feb 2018 According to an Endocyte media release, enrollment for this trial is expected to begin in the second quarter of 2018 and is expected to be completed in 18-24 months.
- 26 Feb 2018 According to an Endocyte media release, the trial will include two interim assessments of efficacy, which could potentially lead to an early approval for 177Lu-PSMA-617.The first interim assessment of OS could occur as early as the second half of 2019.
- 26 Feb 2018 According to an Endocyte media release, following a successful End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the company has finalized the design for this phase III trial.