EQUIP Trial: Estrogen for Quality of Life in Metastatic Prostate Cancer
This study, called the EQUIP trial, is looking at whether adding transdermal estrogen (a patch that delivers estrogen through the skin) to standard prostate cancer treatment can improve quality of life for men with newly diagnosed or recurrent metastatic hormone-sensitive prostate cancer. Standard treatments often lower hormone levels, which can cause side effects like hot flashes, fatigue, and bone problems. This trial compares giving transdermal estrogen along with an androgen receptor pathway inhibitor (a drug that blocks male hormones) to standard treatment with an LHRH analogue (another hormone-blocking drug) and an androgen receptor pathway inhibitor. The main goal is to see if transdermal estrogen can reduce hot flashes. You may be eligible if you are a man aged 18 or older with confirmed metastatic hormone-sensitive prostate cancer.
- Study design
- This interventional study plans to enroll 60 men. Participants will be randomly assigned to one of two groups to receive different treatment combinations.
- What's involved
- You would undergo bone scans, CT scans, and DEXA scans. You would also have blood samples collected throughout the study. Treatment duration is at least 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- After completing study treatment, you will be followed up at 30 days and then every 6 months for two years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07466498
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~60 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Androgen Receptor Pathway InhibitorTransdermal EstrogenBone ScanComputed TomographyDual X-ray AbsorptiometryGonadotropin-releasing Hormone Analog
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in median daily hot flash score
Measured over From baseline to a minimum of 12 weeks combination therapy
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Michael Schweizer, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 initiated on a first-generation androgen receptor (AR) antagonist (e.g. bicalutamide) prior to enrollment
Hemoglobin ≥ 9 g/dL with no blood transfusion in the past 28 days (measured within 30 days prior to administration of study treatment)
Platelet count ≥ 100 x 10\^9/L (measured within 30 days prior to administration of study treatment)
Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (measured within 30 days prior to administration of study treatment)
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) or serum glutamic pyruvate transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal (measured within 30 days prior to administration of study treatment)
Patient must have creatinine clearance estimated using the Cockcroft-Gault equation (measured within 30 days prior to administration of study treatment)
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) with exception for Gilbert's syndrome (measured within 30 days prior to administration of study treatment)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patients must have a life expectancy ≥ 16 weeks
Patients must be willing and able to comply with protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT, MRI and/or bone scan and is suitable for repeated assessment. Subjects without bone metastases must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for 6 months after last dose of study drug(s) to prevent pregnancy in a partner
Exclusion
Involvement in the planning and/or conduct of the study
Other malignancy unless curatively treated with no evidence of disease for ≥ 2 years. Exceptions include adequately treated non-melanoma skin cancer or non-muscle invasive bladder cancer
Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patient with spinal cord compression unless considered to have received definitive therapy for this and evidence of clinically stable disease for 28 days
Patients considered inappropriate to receive docetaxel chemotherapy by their treating provider
Use of corticosteroids at a dose equivalent to \> 10 mg of prednisone daily
Planning to receive concurrent treatment with another systemic cancer therapy, aside from an LHRH analogue
Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, uncontrolled hypertension (blood pressure \[BP\] ≥ 165/100), unstable spinal cord compression, superior vena cava syndrome or extensive interstitial lung disease
Patients with a known hypersensitivity to transdermal estradiol, LHRH analogue, ARSIs or any of the excipients of these products
Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through body or other body fluids
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Evidence of a pre-existing condition that, in the opinion of the investigator, would put the patient at risk from estradiol therapy.
Some examples include: history of blood clotting disorder, migraines with aura or other focal neurological symptom, angina (New York Heart Association grade III or higher)
Prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study and not currently on systemic anticoagulation
Excluded due to risk of venous thromboembolism from hormone supplementation
Patients with New York Heart Association (NYHA) class III or IV heart failure or history of a prior myocardial infarction (MI) or cerebrovascular accident (stroke or transient ischemic attack) within 5 years of enrollment to the study
Excluded due to increased risk of cardiovascular events with estradiol supplementation
What this trial measures
- Change in median daily hot flash scoreFrom baseline to a minimum of 12 weeks combination therapy
As measured by Mayo Clinic Hot Flash Daily score. Will calculate the difference between the first hot flash score after 12 weeks and the baseline hot flash score for each patient, and then use difference-in-difference analysis to compare the mean changes between cohorts 1 and 2 using a two-sample t-test.