VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Phase of Trial: Phase III
Latest Information Update: 19 Jan 2019
At a glance
- Drugs PSMA 617 (Primary) ; Antineoplastics
- Indications Prostate cancer
- Focus Registrational; Therapeutic Use
- Acronyms VISION
- Sponsors Endocyte
- 10 Sep 2018 According to an Endocyte media release, regardless of the outcome of the rPFS assessment, Endocyte intends to continue to follow patients in the VISION trial in order to assess the final OS alternative primary endpoint.
- 10 Sep 2018 Under the updated protocol, the two interim assessments previously planned at 50% and 70% of OS events will be replaced with a single assessment of rPFS, according to an Endocyte media release. The rPFS analysis is expected in late 2019, approximately one year ahead of final OS analysis.
- 10 Sep 2018 According to an Endocyte media release, the company announced that following a meeting with the FDA it has been determined that radiographic progression-free survival (rPFS) is an appropriate alternative primary efficacy endpoint in this trial to support the submission of a New Drug Application (NDA) for full FDA approval.