Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Healthy Volunteers: f
View:

• Patients age 40 or higher with prostate cancer that has been previously treated with primary definitive local therapies (prostatectomy with or without salvage radiation, or primary prostate radiation) and subsequently experiencing rising PSA meeting criteria for biochemical failure (PSA \>0.2 ng/dL x2 following prostatectomy, or PSA \> 2 + nadir value following primary radiation).

• PSMA PET/CT (Ga68, piflutolastat F-18, or other FDA-approved tracer) during time of biochemical recurrence, and within 6 weeks of registration, showing at least one lesion suspicious for recurrent prostate cancer based on size and/or SUV.

• Testosterone \>100 ng/dL within 6 months prior to enrollment with no intervening hormonal therapies.

• Assigned by treating physician to receive standard-of-care AR antagonist monotherapy, using FDA-approved apalutamide, darolutamide, or enzalutamide.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
David Einstein, MD
deinstei@bidmc.harvard.edu
(617) 667-1957
Time Frame
Start Date: 2023-01-19
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 15
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Dana-Farber Cancer Institute
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov