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Radioisotope Therapy

177Lu-PSMA-617 for Prostate Cancer (VISION Trial)

Phase 3

Waitlist Available

Research Sponsored by Endocyte

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)

Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until date of end of treatment (eot), assessed up to 43 months (final os analysis cut-off date = 27-jan-2021)

Awards & highlights

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.

Who is the study for?

This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread despite previous treatments. They must have a certain level of health, confirmed by tests, and not have had specific recent cancer treatments or other serious medical conditions.Check my eligibility

What is being tested?

The study is testing the effectiveness of a drug called 177Lu-PSMA-617 combined with the best standard care versus the best standard care alone in improving survival without cancer progression in patients with PSMA-positive metastatic castration-resistant prostate cancer.See study design

What are the potential side effects?

Possible side effects include nausea, fatigue, dry mouth, changes in blood counts leading to increased risk of infection or bleeding, kidney issues, and temporary pain flare-ups related to treatment.

VISION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You must have received at least one type of medication called NAAD (such as enzalutamide or abiraterone).

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You have advanced prostate cancer that is getting worse. This will be determined by specific criteria set by the doctors.

VISION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first documented psa response till 30 days safety fup, assessed up to 43 months (final os analysis cut-off date = 27-jan-2021)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first documented psa response till 30 days safety fup, assessed up to 43 months (final os analysis cut-off date = 27-jan-2021)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first documented psa response till 30 days safety fup, assessed up to 43 months (final os analysis cut-off date = 27-jan-2021) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Radiographic Progression-free Survival (rPFS)

Secondary outcome measures

Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level

Best Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Level

Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level

+25 more

Side effects data

From 2023 Phase 3 trial • 831 Patients • NCT03511664

43%

Fatigue

39%

Dry mouth

35%

Nausea

30%

Anaemia

23%

Back pain

22%

Arthralgia

21%

Decreased appetite

19%

Constipation

19%

Diarrhoea

18%

Vomiting

17%

Thrombocytopenia

14%

Lymphopenia

12%

Leukopenia

11%

Weight decreased

10%

Urinary tract infection

10%

Bone pain

Oedema peripheral

Dyspnoea

Neutropenia

Pain in extremity

Cough

Dizziness

Hypocalcaemia

Haematuria

Fall

Hypokalaemia

Headache

Hypertension

Pyrexia

Asthenia

Pain

Abdominal pain

Blood creatinine increased

Hypophosphataemia

Insomnia

Sepsis

Acute kidney injury

Mental status changes

Urinary tract obstruction

Urinary retention

Infection

Urosepsis

Deep vein thrombosis

Dehydration

Pancytopenia

Hypotension

Ischaemic stroke

Pulmonary embolism

Spinal cord compression

Syncope

Subdural haematoma

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

Best Supportive/Best Standard of Care (BS/BSOC) Alone

VISION Trial Design

2Treatment groups

Experimental Treatment

Group I: Best supportive/best standard of care (BS/BSOC) aloneExperimental Treatment1 Intervention

Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator

Group II: 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)Experimental Treatment2 Interventions

Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

177Lu-PSMA-617

2018

Completed Phase 3

~840

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

EndocyteLead Sponsor

35 Previous Clinical Trials

2,465 Total Patients Enrolled

3 Trials studying Prostate Cancer

441 Patients Enrolled for Prostate Cancer

Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals

2,154 Previous Clinical Trials

4,010,991 Total Patients Enrolled

18 Trials studying Prostate Cancer

2,772 Patients Enrolled for Prostate Cancer

Media Library

177Lu-PSMA-617 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03511664 — Phase 3

Prostate Cancer Research Study Groups: 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC), Best supportive/best standard of care (BS/BSOC) alone

Prostate Cancer Clinical Trial 2023: 177Lu-PSMA-617 Highlights & Side Effects. Trial Name: NCT03511664 — Phase 3

177Lu-PSMA-617 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03511664 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI