TerminatedNot Applicable

Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy

Stopped: So far, we have not been able to collect meaningful data for these patients which also led to our decision to close this study before attempting write up and publish any results

United States35 participantsStarted 2023-08-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial has been terminated — can you tell me why it was stopped early, and whether that affects the safety or usefulness of any data it collected about PSMA radionuclide therapy?
2Since this specific trial is no longer recruiting or running, are there other active trials studying PSMA-targeted radionuclide therapy for metastatic castration-resistant prostate cancer that might be worth considering instead?
3This trial was listed without a standard phase, which can mean it was more of a data-collection or registry-type study — does that mean less was known about risks going in, and how does that compare to approved treatments like lutetium PSMA-617 that already have phase 3 data behind them?
4Given that my cancer would need to be confirmed as PSMA-positive to even be relevant to this kind of treatment, should I be getting a PSMA PET scan, and what would the results mean for my treatment options beyond this particular trial?
5Since this trial is terminated, is standard-of-care PSMA radionuclide therapy already available to me outside of a clinical trial, and would that be a better path to discuss right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer

Timeframe: 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

Trial details

NCT IDNCT05995236

SponsorMethodist Health System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-09

View on ClinicalTrials.gov More Prostate Cancer trials