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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 years
- Procedures mentioned: Blood draws, MRI scans, CT scans, X-rays
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether estrogen given through the skin improves quality of life more than standard hormone treatment. Both groups also get a drug that blocks male hormones. It is for men with newly found or returning prostate cancer that has spread and still responds to hormone treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, agree to join, and be able to follow the study’s treatment and visit schedule.
- Have prostate adenocarcinoma confirmed by a tissue test, with scans showing cancer that has spread and still responds to hormone treatment.
- Have no past chemotherapy for hormone-sensitive prostate cancer and no past LHRH or newer hormone-blocking drugs. Earlier drugs, such as bicalutamide, are allowed.
- Meet the study’s blood cell and liver test limits, have kidney function checked, and have had no blood transfusion in the past 28 days.
- Be able to care for yourself and be out of bed or a chair for at least half the day. Be expected to live at least 16 weeks.
- Have at least one cancer spot that can be checked on repeat scans. If cancer has not spread to bone, a spot must meet the study’s size-measurement rules.
- If sexually active with a partner who could become pregnant, agree to use two highly effective birth control methods during treatment and for 6 months after the last dose.
Who can't join
- Help plan or run the study, or have a condition or life situation that could make consent, treatment, or follow-up unsafe or difficult.
- Have another cancer, unless treated to cure it and cancer-free for at least 2 years. Some treated skin and bladder cancers are allowed.
- Have uncontrolled brain cancer symptoms, or pressure on the spinal cord unless fully treated and stable for 28 days.
- Cannot safely receive docetaxel chemotherapy; take steroids above the equivalent of 10 mg of prednisone daily; or plan other cancer treatment that works throughout the body, except an LHRH drug.
- Have major surgery within 2 weeks before treatment, have not recovered from major surgery, or have a serious uncontrolled illness or infection, including active hepatitis B or C.
- Have an allergy to study drugs or their ingredients, or a condition that makes estrogen unsafe, such as a clotting disorder, certain migraines with warning symptoms, or severe chest pain from heart disease.
- Have had a deep vein blood clot or a clot in the lungs within 5 years and are not currently taking blood-thinning medicine.
- Have severe heart failure, or have had a heart attack, stroke, or brief stroke-like episode within 5 years.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 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 Criteria: * 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
Study sites (1)
WA
- Fred Hutch/University of Washington Cancer Consortium · Seattle, WA 98109Michael Schweizer, MD · Study contact · 206-606-6252 · schweize@uw.eduMichael Schweizer, MD · Principal investigatorMore trials in Seattle