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Trial Title:
Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
NCT ID:
NCT05683964
Condition:
Prostate Adenocarcinoma
Prostate Cancer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Conditions: Official terms:
Prostatic Neoplasms
Adenocarcinoma
Hypersensitivity
Conditions: Keywords:
Prostate Adenocarcinoma
Prostate Cancer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]
Description:
per standard care
Arm group label:
Androgen Receptor Antagonist Monotherapy
Intervention type:
Diagnostic Test
Intervention name:
Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Description:
Per standard care
Arm group label:
Androgen Receptor Antagonist Monotherapy
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.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
David J. Einstein, MD
Phone:
617-667-2100
Email:
deinstei@bidmc.harvard.edu
Investigator:
Last name:
David J. Einstein, MD
Email:
Principal Investigator
Start date:
January 19, 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Beth Israel Deaconess Medical Center
Agency class:
Other
Collaborator:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Beth Israel Deaconess Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05683964
