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Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

NCT05683964 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-02-13

No results posted yet for this study

Summary

The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate cancer. This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy.

The names of the treatment interventions involved in this study are:

* Androgen receptor antagonist monotherapy.
* PSMA PET/CT scan

It is expected that about 15 people will take part in this research study.

Participation in this research study is expected to last about 4 weeks.

Conditions

  • Prostate Adenocarcinoma
  • Prostate Cancer
  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

DRUG

Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]

per standard care

DIAGNOSTIC_TEST

Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan

Per standard care

Sponsors & Collaborators

Principal Investigators

  • David Einstein, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-19
Primary Completion
2025-09-18
Completion
2026-09-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05683964 on ClinicalTrials.gov