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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA radionuclide therapy | Drug | Collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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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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:
No prior therapy with Radium-223 Dichloride
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kavya Vinod Mankulangara, PharmD | Contact | (214) 947-74604 | clinicalresearch@mhd.com | |
| Bethany Brauer, MPH | Contact | (214) 947-4459 | clinicalresearch@mhd.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexandru Bageac, MD | Methodist Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Dallas Medical Center | Recruiting | Dallas | Texas | 75203 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |