VISION Study of 177Lu-PSMA-617 in the treatment of PSMA-Positive mCRPC

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  247036

• Contact name

  Johann Sebastian de Bono

• Contact email

  Johann.de-bono@icr.ac.uk

• Sponsor organisation

  Endocyte Inc., US

• Eudract number

  2018-000459-41

• Clinicaltrials.gov Identifier

  NCT03511664

• Clinicaltrials.gov Identifier

  not applicable , not applicable

• Duration of Study in the UK

  3 years, 7 months, 17 days

• Research summary

  This is a Phase 3 international study investigating an experimental drug called 177Lu-PSMA-617 (also called Lu-PSMA) in the treatment of patients with prostate cancer. The purpose of this study is to compare Lu-PSMA plus best supportive/ best standard-of-care (investigational treatment group) with the best supportive/best standard-of-care alone.
  Eligible patients will be randomly assigned to each treatment. There will be a 2 in 3 chance to receive the experimental drug plus standard of care and 1 in 3 chance to receive best supportive/best standard of care alone. The participants (and study doctors) will know which treatment group they will be in.

  Lu-PSMA is a radionuclide therapy which works by carrying radiation directly to tumours in order to kill the tumour and not healthy normal tissue so the disease will be better treated. Specifically Lu-PSMA delivers lutetium 177 (a radioactive metal) to cancers of the prostate which often have specific proteins called prostate-specific membrane antigen (PSMA) on the cell surface.

  There are several parts to this study including: screening, to determine eligibility; treatment, which will last 6 to 10 months and occur once every 6 weeks for a maximum of 6 cycles; and follow up, where patients will be contacted every 3 months (±1 month) and will last up to 2 years.

  This study will include a number of examinations, tests and procedures.
  Only patients with prostate cancer that contains the PSMA protein can participate in this study who have had prior treatment with a class of drugs called novel androgen axis drug (such as enzalutamide or abiraterone) and 1 to 2 regimes of treatment with another class of drugs called taxanes.

  The total time in the study will last up to 38 months and about 750 participants are planned to take part in the study.
  The study is sponsored by Endocyte, Inc.

• REC name

  West of Scotland REC 1

• REC reference

  18/WS/0137

• Date of REC Opinion

  4 Sep 2018

• REC opinion

  Further Information Favourable Opinion