Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy
Conditions
Prostate CancerDrugs
PSMA radionuclide therapySummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Colette N Ngo Ndjom, MS
- 214-947-1289
- [email protected]
Principal Investigator
- Alexandru Bageac, MD
Eligibility 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.
Outcome Measures
Primary Outcome Measures
collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer
Timeline
Last Updated
October 23, 2023Start Date
August 16, 2023Today
February 5, 2025Completion Date ( Estimated )
August 2, 2024
Sponsors of this trial
Lead Sponsor
Methodist Health System