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)

R
Roberto Pili, MD

Primary Investigator

Overview

The purpose this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.

Description

Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care or to receive best supportive/best standard of care only. Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen axis drugs [NAADs] (such as abiraterone or enzalutamide) are allowed. The study is open-label and patients will be monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events. A long-term follow-up period will include the collection of survival and treatment updates, adverse events assessment, as well as blood for hematology and chemistry testing. During follow-up, patients will be contacted every 3 months (?1 month) via phone, email, or letter for 24 months or until the the overall censoring rate for survival reduces to a level identified in the SAP. An End of Treatment visit should occur once a patient is to enter the long term follow up. This visit should occur approximately 30 days from the last dose of 177Lu-PSMA-617 or best supportive/best standard of care, but before the initiation of subsequent anti-cancer treatment, outside of what is allowed on study. The planned enrollment for this study is 750 patients.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    prostate cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Male

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
  • Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).

For a full list of participation criteria, please visit clinicaltrials.gov.


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022. Study ID: 1807479345 (PSMA-617-01)

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