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Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05995236
Enrollment
35
Registered
2023-08-16
Start date
2023-08-03
Completion date
2026-07-09
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

DRUGPSMA radionuclide therapy

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

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancerClinical 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 discretionTo 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlexandru Bageac, MD

Methodist Health System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026