Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

NCT05995236 | Unknown DMC

• 1 other identifier: 019.NMD.2022.D
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

PSMA radionuclide therapy DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• \. \>18 years of age
• \. 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alexandru Bageac, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kavya Vinod Mankulangara, PharmD

CONTACT

(214) 947-74604; clinicalresearch@mhd.com

Bethany Brauer, MPH

CONTACT

(214) 947-4459; clinicalresearch@mhd.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: August 2, 2023
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-08

Locations

US (1)