Clinical trial NCT05683964: Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Official title: Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Adenocarcinoma
Prostate Cancer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Keywords: Prostate Adenocarcinoma
Prostate Cancer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2023-01-13
Enrollment: 15
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Proportion of Participants with New Lesions (Flare)
timeFrame: week 1
measure: Proportion of Participants with New Lesions (Flare)
timeFrame: week 4
Secondary outcomes:
measure: Changes in tumor size
timeFrame: week 1
measure: Changes in tumor size
timeFrame: week 4
measure: Changes in tumor SUV
timeFrame: week 1
measure: Changes in tumor SUV
timeFrame: week 4
measure: Changes in serum PSA
timeFrame: week 1
measure: Changes in serum PSA
timeFrame: week 4
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: David Einstein, MD
role: PRINCIPAL_INVESTIGATOR
References: