Estrogen for Quality-of-Life and Immune Modulation in Prostate Cancer (EQUIP)
University of Washington
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.
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 tomo…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Must be willing to provide informed consent prior to any study specific procedures * Age ≥ 18 years * Documented histologically confirmed adenocarcinoma of the prostate * Patients must have evidence of newly diagnosed or relapsed metastatic hormone sensitive prostate cancer on CT, positron emission tomography (PET), MRI or bone scan * No prior chemotherapy for the treatment of hormone sensitive prostate cancer * No prior therapy with an LHRH analogue or next-generation androgen receptor-signaling inhibitor (e.g. abiraterone, enzalutamide, etc.). Participants may have ini…
Interventions
- DrugAndrogen Receptor Pathway Inhibitor
Given per standard of care
- DrugTransdermal Estrogen
Given via transdermal patch
- ProcedureBone Scan
Undergo bone scan
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureDual X-ray Absorptiometry
Undergo DEXA scan
- BiologicalGonadotropin-releasing Hormone Analog
Given per standard of care
- ProcedureMagnetic Resonance Imaging
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington