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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2024-11-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR