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Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05683964
Recruitment Status : Recruiting
First Posted : January 13, 2023
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
David J. Einstein, MD, Beth Israel Deaconess Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Prostate Cancer Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Drug: Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi] Diagnostic Test: Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Actual Study Start Date : January 19, 2023
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]
per standard care

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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants with New Lesions (Flare) [ Time Frame: week 1 ]
    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.

  2. Proportion of Participants with New Lesions (Flare) [ Time Frame: week 4 ]
    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.


Secondary Outcome Measures :
  1. Changes in tumor size [ Time Frame: week 1 ]
    Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean.

  2. Changes in tumor size [ Time Frame: week 4 ]
    Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean.

  3. Changes in tumor SUV [ Time Frame: week 1 ]
    For up to 5 target lesions. Standardized Uptake Value Max and Mean.

  4. Changes in tumor SUV [ Time Frame: week 4 ]
    For up to 5 target lesions. Standardized Uptake Value Max and Mean.

  5. Changes in serum PSA [ Time Frame: week 1 ]
  6. Changes in serum PSA [ Time Frame: week 4 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05683964


Contacts
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Contact: David Einstein, MD (617) 667-1957 deinstei@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: David J. Einstein, MD    617-667-2100    deinstei@bidmc.harvard.edu   
Principal Investigator: David J. Einstein, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: David Einstein, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: David J. Einstein, MD, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05683964    
Other Study ID Numbers: 22-441
First Posted: January 13, 2023    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by David J. Einstein, MD, Beth Israel Deaconess Medical Center:
Prostate Adenocarcinoma
Prostate Cancer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases