Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995236
• Other study ID #: 019.NMD.2022.D
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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