Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT05995236
• Lead Sponsor: Methodist Health System

Brief Summary

This study is a single-center registry study collecting clinical data regarding the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy per the treating physician's discretion. Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion.

Detailed Description

This study is a single-center registry study collecting clinical data regarding the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy per the treating physician's discretion. Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion.

Participants will be followed for two years following the first PSMA procedure. During these visits, participants will also be asked to report any change in their medications. Participants will not need to visit the study doctor more often than their usual treatment unless they have other medical needs. However, if participants experience any significant change in their medical condition they may be asked to have additional tests such as computed tomography (CT) scans, blood tests, etc.

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-02
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-16
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-08-02
• Study Completion: 2024-08-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

• 1. >18 years of age
• 2. Diagnosed with PSMA-positive metastatic castration-resistant prostate cancer and - has consented to undergo PSMA nuclear therapy per the treating physician. Specifically:

  • Metastatic or Locally Advanced AND Inoperable

  • Clear disease progression on PSMA-PET/CT

  • PSMA-PET/CT scan positive disease within 6 weeks

  • Labs:

    • Hemoglobin: >8 g/dL
    • White blood cell count: >2K cells/µL
    • Platelet (Thrombocyte) count: >75 x 109/L

  • No prior therapy with Radium-223 Dichloride

Exclusion Criteria

• Patients who do not meet the Inclusion Criteria laid out in section 4.2 will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer	Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion	To collect clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States