Evaluation of Targeted Radionuclide Therapy of Lu-177 PSM... | NCT07169825

Studies
Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow Function

NCT07169825

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Apr 2, 2026Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Lu-177 PSMA

Interventions

Lu-177
SPECT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2025-06603	Other Identifier	NCI-CTRP Clinical Registry

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2026Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2028Estimated

First Submitted Date

Sep 5, 2025

First Submission Date that Met QC Criteria

Sep 5, 2025

First Posted Date

Sep 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 2, 2026Actual

Name	Class
GE Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA	Experimental		Drug: Lu-177 Other: SPECT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lu-177	Drug	Given by IV	Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Through study completion; an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Males

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guofan Xu, MD	Contact	713-745-9017		gxu2@mdanderson.org

Overall Officials

Name	Affiliation	Role
Guofan Xu, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States

Label	URL
MD Anderson Cancer Center	View source

Intervention Browse Module

MeSH Terms

ID	Term
C000615061	Lutetium-177

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided