Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

NCT ID: NCT05683964

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2026-02-01

Brief 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.

Detailed Description

This research study is a pilot study, and it is the first time investigators are directly examining the effect of standard androgen receptor antagonists on Prostate-Specific Membrane Antigen (PSMA) expression for participants with recurrent, asymptomatic, metastatic hormone-sensitive prostate cancer (mHSPC). This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy.

The research study procedures include screening for eligibility, study imaging and evaluations, blood collections, and follow up visits.

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

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

The U.S. Food and Drug Administration (FDA) has approved apalutamide, darolutamide, and enzalutamide for the treatment of prostate cancer.

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.

Funding for this research study is provided by a philanthropic gift.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

per standard care

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

Intervention Type: DIAGNOSTIC_TEST

Per standard care

Interventions

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

per standard care

Intervention Type: DRUG

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

Per standard care

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• High disease burden, significant symptoms of disease, or other clinical situation requiring medical/surgical castration and/or docetaxel during the time of the study.
• Not suitable for AR antagonist therapy (e.g. inability to swallow pills, poor adherence, advanced liver disease, prohibitive co-payment without available patient assistance funding, contraindicated drug-drug interaction).
• Older-generation AR antagonists (e.g. bicalutamide) are not allowed on study.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David J. Einstein

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Einstein, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Einstein, MD

Role: CONTACT

deinstei@bidmc.harvard.edu

(617) 667-1957

Facility Contacts

David J. Einstein, MD

Role: primary

deinstei@bidmc.harvard.edu

617-667-2100

Other Identifiers

22-441

Identifier Type: -

Identifier Source: org_study_id