Prostate CancerNCT05995236
Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy
An observational study of Prostate Cancer, run by Methodist Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA radionuclide therapy
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2023to 9 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- Patients who do not meet the Inclusion Criteria laid out in section 4.2 will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer
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.
Read the detailed 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.
- Conditions
- Prostate Cancer
- Being tested
- PSMA radionuclide therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA radionuclide therapyDrug
Collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start3 Aug 2023
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandru Bageac, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995236
- Sponsor's protocol ID
- 019.NMD.2022.D
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05995236
- Acronym / sponsor ID
- 019.NMD.2022.D
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason 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
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (1 listed)
- Patients who do not meet the Inclusion Criteria laid out in section 4.2 will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA radionuclide therapyCollect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy | Drug | – |
Primary outcome
collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer
Time frame: 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
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
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
RecruitingPhase 1/2
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
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RecruitingPhase 1
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
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RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandru Bageac, MD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.