Treatment for advanced prostate cancer using PSMA radionuclide therapy
Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Methodist Health System · NCT05995236
This study looks at how well PSMA radionuclide therapy works for men with advanced prostate cancer and tracks their treatment progress over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Methodist Health System (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05995236 on ClinicalTrials.gov |
What this trial studies
This observational study collects clinical data on patients with PSMA-positive metastatic castration-resistant prostate cancer who are treated with PSMA radionuclide therapy at Methodist Dallas Medical Center. The study will follow participants for two years after their first PSMA procedure, gathering information on their treatment outcomes and any changes in their medications. Clinical follow-up will be conducted at the discretion of the treating physician, and additional tests may be performed if significant changes in medical condition occur.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with PSMA-positive metastatic castration-resistant prostate cancer who consent to undergo PSMA nuclear therapy.
Not a fit: Patients who do not meet the inclusion criteria, such as those with prior therapy using Radium-223 Dichloride, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of PSMA radionuclide therapy for treating advanced prostate cancer.
How similar studies have performed: While this approach is being explored, the specific application of PSMA radionuclide therapy in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dallas, Texas
- Methodist Dallas Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Alexandru Bageac, MD — Methodist Health System
- Study coordinator: Kavya Vinod Mankulangara, PharmD
- Email: clinicalresearch@mhd.com
- Phone: (214) 947-74604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer