Recruiting

Pluvicto

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07169825

Conditions

Lu-177 PSMA

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Lu-177

SPECT

Study Details

Brief 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.

Conditions

Lu-177 PSMA

Study ID

NCT07169825

Start date

Mar 30, 2026

Status verified date

Jul, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA

Interventions

Lu-177

Given by IV

SPECT

SPECT/CT

Primary outcome measure

  • safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Guofan Xu, MD

713-745-9017gxu2@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Guofan Xu, MD

713-745-9017gxu2@mdanderson.org

Principal Investigator:

Guofan Xu, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-04.