Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

Methodist Health System

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Drug: PSMA radionuclide therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05995236

019.NMD.2022.D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.