Androgen Receptor Antagonists for Prostate Cancer

Phase < 1

Recruiting

Led By David Einstein, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore if hormonal therapies can increase PSMA levels in recurrent prostate cancer patients via PET/CT scans. 15 participants will receive androgen receptor antagonist monotherapy for 4 weeks.

Who is the study for?

Men aged 40+ with prostate cancer previously treated but now showing rising PSA levels indicating recurrence. They must have a PSMA PET/CT scan suggesting recurrent cancer, normal testosterone levels, and be prescribed standard AR antagonist therapy (apalutamide, darolutamide, or enzalutamide) by their doctor.

What is being tested?

This study tests if early hormonal therapies increase PSMA detected by PET/CT scans in men with recurring prostate cancer. About 15 participants will receive standard AR antagonist monotherapy and undergo PSMA level measurements for approximately 4 weeks.

What are the potential side effects?

Possible side effects of the AR antagonists apalutamide, darolutamide, and enzalutamide include fatigue, high blood pressure, skin rash, falls or fractures due to bone weakness; digestive issues like nausea or diarrhea; and potential liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants with New Lesions (Flare)

Secondary study objectives

Changes in tumor SUV

Changes in tumor size

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Androgen Receptor Antagonist MonotherapyExperimental Treatment2 Interventions

* 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.

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