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OpenTrials
Terminated

NCT Number: NCT05995236

Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

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.

Why the study stopped: So far, we have not been able to collect meaningful data for these patients which also led to our decision to close this study before attempting write up and publish any results
Terminated

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PSMA radionuclide therapy

Drug

Collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy

Primary outcomes

  1. collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2023
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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