Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jan 2023
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
January 13, 2023
CompletedStudy Start
First participant enrolled
January 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedFebruary 13, 2026
February 1, 2026
2.7 years
December 19, 2022
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (6)
Changes in tumor size
week 1
Changes in tumor size
week 4
Changes in tumor SUV
week 1
Changes in tumor SUV
week 4
Changes in serum PSA
week 1
- +1 more secondary outcomes
Study Arms (1)
Androgen Receptor Antagonist Monotherapy
EXPERIMENTAL* 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.
Interventions
per standard care
Per standard care
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- Dana-Farber Cancer Institutecollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Einstein, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 19, 2022
First Posted
January 13, 2023
Study Start
January 19, 2023
Primary Completion
September 18, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.