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Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05995236
Collaborator
(none)
400
Enrollment
1
Location
12
Anticipated Duration (Months)
33.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PSMA radionuclide therapy

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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date :
Aug 2, 2023
Anticipated Primary Completion Date :
Aug 2, 2024
Anticipated Study Completion Date :
Aug 2, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

    1. 18 years of age

    1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Alexandru Bageac, MD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT05995236
Other Study ID Numbers:
  • 019.NMD.2022.D
First Posted:
Aug 16, 2023
Last Update Posted:
Aug 16, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Aug 16, 2023