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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05995236
Other study ID # 019.NMD.2022.D
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2, 2023
Est. completion date August 2, 2024

Study information

Verified date August 2023
Source Methodist Health System
Contact Kavya Vinod Mankulangara, PharmD
Phone (214) 947-74604
Email clinicalresearch@mhd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date August 2, 2024
Est. primary completion date August 2, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer 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 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
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