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.
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
- Conditions the study is for
- Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- 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 Sep 2026
- Phase
- Early Phase 1
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
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.
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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
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)
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
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
Changes in tumor SUV
For up to 5 target lesions. Standardized Uptake Value Max and Mean.
Measured: week 1
Changes in tumor SUV
For up to 5 target lesions. Standardized Uptake Value Max and Mean.
Measured: week 4
Changes in serum PSA
Measured: week 1
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.
- First posted13 Jan 2023
- Study start19 Jan 2023
- Primary completion18 Sep 2025
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, David J. Einstein, Beth Israel Deaconess Medical Center
- Investigators
- David Einstein, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683964
- Sponsor's protocol ID
- 22-441
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2022
- Last updated
- 13 Feb 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.