NCT07466498

Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial

Estrogen for Quality-of-Life and Immune Modulation in Prostate Cancer (EQUIP)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial compares giving estrogen with an androgen receptor signaling inhibitor to standard of care luteinizing hormone-releasing hormone (LHRH) analogues with an androgen receptor signaling inhibitor for improving quality of life for patients with hormone sensitive prostate cancer that is newly diagnosed or that has come back after a period of improvement (recurrent) and has spread from where it first started (primary site) to other places in the body (metastatic). Standard prostate cancer treatment decreases hormone levels, specifically estrogen, in the body which can lead to hot flashes, fatigue, decreased bone health, and cardiovascular and metabolic dysfunction. Transdermal estrogen may help to alleviate these symptoms. Androgen receptor signaling inhibitors work by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. LHRH analogues are a type of androgen deprivation therapy that blocks the use of androgen by the tumor cells. Giving estrogen with androgen receptor signaling inhibitor may improve quality of life in men with newly diagnosed or recurrent metastatic hormone sensitive prostate cancer.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 cohorts. COHORT 1: Patients receive standard of care LHRH agonist or LHRH antagonist according to the Food and Drug Administration approved dose and schedule in the absence of disease progression or unacceptable toxicity. Starting 4 weeks after initiation of LHRH agonist/antagonist, patients also receive ARSI per physician's choice for a minimum of 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with a median daily hot flash score ≥ 6 after 12 weeks of therapy may crossover to cohort 2. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI), bone scan, dual x-ray absorptiometry (DEXA) scan and blood sample collection throughout the study. COHORT 2: Patients receive estrogen via transdermal patch on days 1, 4, 8, 12, 16, 20, 24 and 28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Starting 4 weeks after initiation of transdermal estrogen, patients also receive ARSI per physician's choice for a minimum of 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, bone scan, DEXA scan and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days and every 6 months for 2 years.

Conditions

• Castration-Sensitive Prostate Adenocarcinoma
• Metastatic Castration-Sensitive Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Androgen Receptor Pathway Inhibitor	Given per standard of care
DRUG	Transdermal Estrogen	Given via transdermal patch
PROCEDURE	Bone Scan	Undergo bone scan
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Dual X-ray Absorptiometry	Undergo DEXA scan
BIOLOGICAL	Gonadotropin-releasing Hormone Analog	Given per standard of care
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Survey Administration	Ancillary studies
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2026-08-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study