MedTrace Logo

Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging

NCT07069465 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-16

No results posted yet for this study

Summary

This is a pilot, non-randomized, two-cohort interventional study in patients who meet the inclusion criteria, using an FDA- approved androgen deprivation agent for a 3 or 6-week course of treatment prior to standard-of-care RALP with PLND. The intent of the study is to determine the effect of ADT on PSMA expression as measured by PSMA-PET scan. A second PSMA-PET scan will be performed after ADT for either 3 or 6 weeks, depending on cohort, prior to RALP and PLND.

Conditions

Interventions

DIAGNOSTIC_TEST

flotufolastat F 18

PSMA-PET scan with Posluma agent (x2)

DRUG

Relugolix 120 MG

Administration of oral ADT for 3 and 6 weeks

DIAGNOSTIC_TEST

Serum PSA and Testosterone

Serum PSA and testosterone at study initiation and again at 3 and 6 weeks after initiation of ADT

Sponsors & Collaborators

  • Blue Earth Diagnostics

    collaborator INDUSTRY

  • Texas Health Resources

    collaborator OTHER

  • Urology Clinics of North Texas

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2024-11-06
Completion
2024-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069465 on ClinicalTrials.gov