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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Institute for Prostate Cancer Research (IPCR)

  collaborator UNKNOWN

• University of Washington

  lead OTHER

Principal Investigators

• Michael Schweizer, MD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2029-06-01

Completion

2029-06-01

FDA Drug

Yes

Countries

• United States

Study Locations