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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07466498
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1 (LHRH agonist/antagonist and ARSI)
    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 CT scan or MRI, bone scan, DEXA scan and blood sample collection throughout the study.
  • Experimental: Cohort 2 (Estrogen and ARSI)
    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.

Primary Outcome Measure

Change in median daily hot flash score [ Time Frame: From baseline to a minimum of 12 weeks combination therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Michael Schweizer, MD
[email protected]
206-606-6252
Michael Schweizer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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