Lu-177 PSMAPhase 4NCT07169825
Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow Function
A Phase 4 study testing Lu-177 and SPECT in people with Lu-177 PSMA, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To determine the dose of Pluvicto therapy absorbed in the tumors and organs of patients whose kidneys and/or bone marrow are not working properly. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Lu-177 PSMA
- What is being tested?
- Lu-177 and SPECT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to 1 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pluvicto therapy patients without renal or marrow function complications
- Participants who do not wish to be imaged multiple times as per the study protocol.
- Women and children since this is treatment for prostate cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Guofan Xu, MD, 713-745-9017, gxu2@mdanderson.org
Guofan Xu, MD
About this study
To determine the dose of Pluvicto therapy absorbed in the tumors and organs of patients whose kidneys and/or bone marrow are not working properly.
Read the detailed description
Primary Objectives
- To determine the personalized radiation dose to tumors and critical organs of participants with compromised renal and / or bone marrow function.
Secondary Objectives
- To compare target radiation doses based on varying SPECT scan duration. Plot the variability in target radiation dose versus scan duration.
- To compare the image quality and dosimetry results when considering the low, high, and both energy peaks of Lu-177.
- To compare target radiation doses based on multiple imaging time points versus a single time point and identify which time point is most suited for this evaluation.
- To compare target radiation doses derived from organ versus voxel dosimetry calculation.
- Conditions
- Lu-177 PSMA
- Being tested
- Lu-177, SPECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu-177Drug
Given by IV
SPECTOther
SPECT/CT
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA | Experimental | Not described Receives: Drug: Lu-177; Other: SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start30 Mar 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lu-177 PSMAStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Guofan Xu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169825
- Sponsor's protocol ID
- 2024-1702
- Other IDs
- NCI-2025-06603
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow Function
- ClinicalTrials.gov ID
- NCT07169825
- Acronym / sponsor ID
- 2024-1702
- Conditions
- Lu-177 PSMA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 12 Sep 2025 (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.
To determine the dose of Pluvicto therapy absorbed in the tumors and organs of patients whose kidneys and/or bone marrow are not working properly.
Detailed description
Primary Objectives
- To determine the personalized radiation dose to tumors and critical organs of participants with compromised renal and / or bone marrow function.
Secondary Objectives
- To compare target radiation doses based on varying SPECT scan duration. Plot the variability in target radiation dose versus scan duration.
- To compare the image quality and dosimetry results when considering the low, high, and both energy peaks of Lu-177.
- To compare target radiation doses based on multiple imaging time points versus a single time point and identify which time point is most suited for this evaluation.
- To compare target radiation doses derived from organ versus voxel dosimetry calculation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA | Experimental | Drug: Lu-177, Other: SPECT |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Pluvicto therapy patients without renal or marrow function complications
- Participants who do not wish to be imaged multiple times as per the study protocol.
- Women and children since this is treatment for prostate cancer.
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 |
|---|---|---|
| Lu-177Given by IV | Drug | Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA |
| SPECTSPECT/CT | Other | Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA |
Primary outcome
safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Lu-177 PSMA
Active, not recruitingPhase 3
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Prostatic Neoplasms
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
Active, not recruitingPhase 2
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Active, not recruitingPhase 2
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
Prostatic Neoplasm
RecruitingPhase 3
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
Oligometastatic Prostate Cancer (OMPC)
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.
Guofan Xu, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lu-177 and SPECT in people with Lu-177 PSMA, run by M.D. Anderson Cancer Center 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 0 inclusion and 3 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: looking for participants now, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guofan Xu, MD (713-745-9017, gxu2@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year). 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.