Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05683964
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Jan 19, 2023
Status verified
Feb 2026
Primary completion
Sep 18, 2025
Completion
Sep 1, 2026

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Androgen Receptor Antagonist Monotherapy
    * Participants will receive pre-determined doses of apalutamide, darolutamide, or enzalutamide per standard care. * Participants will undergo Prostate-Specific Membrane Antigen (PSMA) PET/CT scans at weeks 1 and 4.

Primary Outcome Measure

Proportion of Participants with New Lesions (Flare) [ Time Frame: week 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

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