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)

Investigating the Effectiveness of an Investigational Medication in Prostate Cancer with PSMA (Prostate-Specific Membrane Antigen)

Recruiting
19 years - 100 years
Male
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

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.
Participants will not be paid for their participation.

Eligibility of study

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

  • Conditions: prostate cancer,prostate,cancer,oncology
  • Age: 19 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.

Updated on 19 Feb 2024. Study ID: 1807479345 (PSMA-617-01)

The purpose of this study is to investigate the effectiveness of an investigational medication in patients with prostate cancer that is PSMA-positive and has spread to other parts of the body. This study focuses on comparing the survival of patients receiving the investigational medication along with the best supportive care to those receiving only the best supportive care. PSMA stands for Prostate-Specific Membrane Antigen, a protein found in high amounts on prostate cancer cells.

Participants in this study will be randomly assigned to different study arms. One group will receive the investigational medication along with standard supportive care, while the other group will receive only the standard supportive care. The study will monitor patients for their survival, disease progression, and any side effects during and after the treatment period. Blood tests will also be conducted to check health indicators.

  • Who can participate: Patients aged 18 and older with confirmed prostate cancer, who have undergone orchiectomy or are on ongoing androgen-deprivation therapy with low testosterone levels, are eligible. For detailed criteria, refer to the clinical trial listing.
  • Study details: Participants will be randomly assigned to receive either the investigational medication with supportive care or supportive care alone. The investigational medication is not a standard treatment and is being tested for its effects on prostate cancer.
  • Study Timelines: The study will last 6 to 10 months.

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