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Trial Title:
Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy
NCT ID:
NCT05995236
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
PSMA radionuclide therapy
Description:
Collect clinical data related to treatment of PSMA-positive metastatic
castration-resistant prostate cancer treated with PSMA radionuclide therapy
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.
Criteria for eligibility:
Study pop:
The plan for Methodist Dallas Medical Center will be to collect data from 10-20 patients
with PSMA-positive metastatic castration-resistant prostate cancer per year for
anticipated 50-100 total patients over the next five years. We estimated this number
based on the number of patient with prostate cancer treated within Methodist Heath
System.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Methodist Dallas Medical Center
Address:
City:
Dallas
Zip:
75203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Colette N Ngo Ndjom, MS
Phone:
214-947-1289
Phone ext:
71289
Email:
mhsirb@mhd.com
Contact backup:
Last name:
Loretta W Bedell, MPH
Phone:
217-947-4680
Phone ext:
74680
Email:
mhsirb@mhd.com
Investigator:
Last name:
Alejandro Bageac, MD
Email:
Principal Investigator
Start date:
August 2, 2023
Completion date:
August 2, 2024
Lead sponsor:
Agency:
Methodist Health System
Agency class:
Other
Source:
Methodist Health System
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05995236
