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.
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
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
Parallel
Androgen Receptor Pathway Inhibitor
DrugGiven per standard of care
Transdermal Estrogen
DrugGiven via transdermal patch
Bone Scan
Procedure/SurgeryUndergo bone scan
Computed Tomography
Procedure/SurgeryUndergo CT scan
Dual X-ray Absorptiometry
Procedure/SurgeryUndergo DEXA scan
Gonadotropin-releasing Hormone Analog
Biological/VaccineGiven per standard of care
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Survey Administration
Other interventionAncillary studies
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Change in median daily hot flash score
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.
Change in quality of life (QOL) domains
Assessed via patient-reported outcome measure questionnaires. Average change in QOL scores (total and for each domain) for each questionnaire will be calculated at each timepoint. A paired t-test will be used to assess for statistically significant changes in QOL from baseline to subsequent timepoints and linear mixed effects models will be used to evaluate trends over all timepoints.
Bone mineral density
Assessed from change in T-score (or Z-score) via dual energy x-ray absorptiometry.
Changes in metabolic parameters: Mean change in hemoglobin A1c
Assessed via results of hemoglobin A1c.
Changes in metabolic parameters: Mean change in lipid panel values
Assessed via results of lipid panel \[total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides\].
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Fred Hutchinson Cancer Center
Lead sponsor
Institute for Prostate Cancer Research (IPCR)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
