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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Urology Clinics of North Texas
Study ID
NCT07069465
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • flotufolastat F 18 — DIAGNOSTIC_TEST
    PSMA-PET scan with Posluma agent (x2)
  • Relugolix 120 MG — DRUG
    Administration of oral ADT for 3 and 6 weeks
  • Serum PSA and Testosterone — DIAGNOSTIC_TEST
    Serum PSA and testosterone at study initiation and again at 3 and 6 weeks after initiation of ADT

Study Details

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.

Key Dates

Start date
Jun 15, 2024
Status verified
Jun 2025
Primary completion
Nov 6, 2024
Completion
Nov 6, 2024

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Cohort A
    5 patients (Cohort A) undergo a second study PSMA-PET with POSLUMA® 3 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.
  • Active Comparator: Cohort B
    5 patients (Cohort B) undergo a second study PSMA-PET with POSLUMA® 6 weeks after initiation of ADT and discontinue ADT immediately after the scan is completed.

Primary Outcome Measure

1. Mean change in maximum standardized uptake value (SUVmax) per lesion as measured by PSMA-PET (POSLUMA®) from baseline to post-ADT [ Time Frame: 3-6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Urology Clinics of North TexasDallasTexas75231-

Find similar trials in Dallas, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Urology Clinics of North Texas· Dallas, TX

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