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Prostate AdenocarcinomaEarly Phase 1NCT05683964

Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

A Early Phase 1 study testing Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi] and Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan in people with Prostate Adenocarcinoma and Prostate Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older, men only
What is being tested?
Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi] and Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
19 Jan 2023to 1 Jun 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi], Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Keywords
Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]Drug

    per standard care

  • Prostate-Specific Membrane Antigen (PSMA) PET/CT ScanDiagnostic test

    Per standard care

Study groups in NCT05683964
Study groupRoleWhat they receive
Androgen Receptor Antagonist MonotherapyExperimental* 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.
Receives: Drug: Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]; Diagnostic Test: Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: week 1

  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.

    Measured: week 4

Secondary outcomes (6)

  1. Changes in tumor size

    Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean.

    Measured: week 1

  2. Changes in tumor size

    Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean.

    Measured: week 4

  3. Changes in tumor SUV

    For up to 5 target lesions. Standardized Uptake Value Max and Mean.

    Measured: week 1

  4. Changes in tumor SUV

    For up to 5 target lesions. Standardized Uptake Value Max and Mean.

    Measured: week 4

  5. Changes in serum PSA

    Measured: week 1

  6. Changes in serum PSA

    Measured: week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023
  2. Study start19 Jan 2023
  3. Primary completion18 Sep 2025
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05683964
Sponsor's protocol ID
22-441
Status last verified
Oct 2026
First submitted
19 Dec 2022
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi] and Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan in people with Prostate Adenocarcinoma and Prostate Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants with New Lesions (Flare) (time frame: week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05683964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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