Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

NCT ID: NCT05995236

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-02

Study Completion Date

2024-08-02

Brief Summary

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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.

Detailed Description

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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.

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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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PSMA radionuclide therapy

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

Intervention Type DRUG

Eligibility Criteria

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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:

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandru Bageac, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Health System

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kavya Vinod Mankulangara, PharmD

Role: CONTACT

(214) 947-74604

Bethany Brauer, MPH

Role: CONTACT

(214) 947-4459

Facility Contacts

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Colette N Ngo Ndjom, MS

Role: primary

214-947-1289 ext. 71289

Loretta W Bedell, MPH

Role: backup

217-947-4680 ext. 74680

Other Identifiers

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019.NMD.2022.D

Identifier Type: -

Identifier Source: org_study_id

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