Personalized Lu-177 PSMA (Pluvicto) dosing for people with reduced kidney or bone marrow function
Official title: Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow Function
Run by M.D. Anderson Cancer Center · NCT07169825 · Data updated 2026-11-12
This trial will try personalized dosing and imaging to see how much Pluvicto (Lu-177 PSMA) radiation reaches tumors and organs in people with prostate cancer who have reduced kidney or bone marrow function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Sex | Men only |
| Enrollment | 25 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2028 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT07169825 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men with prostate cancer who are approved for Pluvicto and have reduced kidney function (approximately GFR 30–50 mL/min or creatinine up to about 2× ULN) or compromised marrow (low WBC or platelets) who can attend multiple post‑therapy imaging visits are ideal candidates.
✕Probably not a fit
Patients without renal or marrow impairment, those not approved for Pluvicto, women or children, or anyone unwilling to undergo multiple imaging visits are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Men approved to receive Pluvicto who have impaired renal function or compromised bone marrow will receive standard Lu-177 PSMA therapy and undergo multiple SPECT imaging sessions. The study will vary SPECT scan duration, analyze low/high energy peaks, and compare single versus multiple imaging timepoints. Dosimetry will be calculated by both organ-based and voxel-based methods to determine absorbed radiation in tumors and critical organs. Results will be used to identify optimal imaging parameters and personalized radiation dose estimates for this vulnerable population.
Why it matters
Potential benefit: If successful, this could enable safer, personalized Pluvicto dosing for patients with kidney or bone marrow impairment, lowering the risk of toxicity while preserving tumor targeting.
How similar studies have gone: Lu-177 PSMA therapy and general dosimetry methods have shown benefit in prostate cancer, but targeted personalized dosimetry for patients with renal or marrow compromise is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Eligibility Criteria * Participants that are approved for Pluvicto therapy and have been identified to have renal complications or compromised marrow function. Renal complication is defined as GFR: 30-50ml/min, creatinine: ULN-twofold ULN; while compromised marrow function is indicated by total WBC 2.5 x 109 L - LLN, or platelet count 75-100 x 109 L. * Participants who agree to be imaged multiple times as defined in the study protocol. Exclusion Criteria * 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.
Where it's running
-
MD Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Guofan Xu, MD — M.D. Anderson Cancer Center
- Study coordinator: Guofan Xu, MD
- Email: gxu2@mdanderson.org
- Phone: 713-745-9017
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.