Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683964
• Other study ID #: 22-441
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 19, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: July 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: David Einstein, MD
• Phone: (617) 667-1957
• Email: deinstei[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Hypersensitivity
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]
per standard care

Diagnostic Test:
• Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Per standard care

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants with New Lesions (Flare)	Defined as the percentage of patients having the appearance of at least one new suspicious lesion or increase in SUV max relative to each individual's baseline.	week 1
Primary	Proportion of Participants with New Lesions (Flare)	Defined as the percentage of patients having the appearance of at least one new suspicious lesion or increase in SUV max relative to each individual's baseline.	week 4
Secondary	Changes in tumor size	Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean.	week 1
Secondary	Changes in tumor size	Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean.	week 4
Secondary	Changes in tumor SUV	For up to 5 target lesions. Standardized Uptake Value Max and Mean.	week 1
Secondary	Changes in tumor SUV	For up to 5 target lesions. Standardized Uptake Value Max and Mean.	week 4
Secondary	Changes in serum PSA		week 1
Secondary	Changes in serum PSA		week 4