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NCT05683964EARLY_PHASE1ACTIVE_NOT_RECRUITING

Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

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

Sponsor: Beth Israel Deaconess Medical Center + Dana-Farber Cancer Institute

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Interventions
Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi], Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Enrollment
9 participants
Primary completion
Sep 2025
Study completion
Sep 2026
First posted
Jan 2023
Last updated
Feb 2026

Primary Endpoints (CT.gov)

Proportion of Participants with New Lesions (Flare)

Time frame: week 1

Proportion of Participants with New Lesions (Flare)

Time frame: week 4

Secondary Endpoints

Changes in tumor size

Changes in tumor size

Changes in tumor SUV

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 si

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov