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

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 study is about