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177Lu-PSMA-617 for Prostate Cancer (VISION Trial)
VISION Trial Summary
This trial compared how well two different treatments worked in patients with mCRPC. The first group received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC), while the second group only received BSC/BSoC.
VISION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVISION Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 831 Patients • NCT03511664VISION Trial Design
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- You have symptoms or signs that suggest your spinal cord is being compressed or may be compressed soon.Patients must be > 18 years of age.Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.You must have received at least one type of medication called NAAD (such as enzalutamide or abiraterone).You have advanced prostate cancer that is getting worse. This will be determined by specific criteria set by the doctors.You must be able to understand and sign an ICF.You must be able to understand and comply with all protocol requirements.Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.You are currently receiving other treatments for cancer, such as chemotherapy, immunotherapy, radiation therapy, or experimental medications.
- Group 1: 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)
- Group 2: Best supportive/best standard of care (BS/BSOC) alone
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants still being sought for this research project?
"The latest information from clinicaltrials.gov shows that this trial is not recruiting patients at the moment, though it was last updated on 8/9/2022. There are 1364 other trials with open recruitment at this time."
What is the purpose of this clinical trial?
"The goal of this trial is to improve radiographic progression-free survival (rPFS) in patients with cancer. Secondary outcomes include change from baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score and Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS. The trial will also assess Concomitant Drug Use for Health Economics Analysis."
Is 177Lu-PSMA-617 a drug that has been approved by the FDA?
"177Lu-PSMA-617 has received a score of 3 for safety. This is based on it being a Phase 3 trial, which contains both efficacy and safety data from multiple rounds of testing."
At how many different sites is this research being conducted?
"There are a total of 52 sites where this study is being conducted. Some notable locations include UCSF Medical Center at Mission Bay in San Francisco, Washington DC VA Medical Center, Nuclear Medicine Service in Washington, and Swedish Cancer Institute in Seattle."
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