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Castration-Sensitive Prostate AdenocarcinomaPhase 2NCT07466498

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

A Phase 2 study testing Androgen Receptor Pathway Inhibitor, Transdermal Estrogen and Bone Scan in people with Castration-Sensitive Prostate Adenocarcinoma and Metastatic Castration-Sensitive Prostate Adenocarcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Androgen Receptor Pathway Inhibitor, Transdermal Estrogen and Bone Scan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to 1 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • History of deep vein thrombosis, pulmonary embolism, myocardial infarction, angina, stroke or transient ischemic attack within 5 years of enrollment to the study
  • Known history of protein C, protein S, antithrombin deficiency or other known thrombophilic disorders
  • History of breast cancer
  • History of viral hepatitis unless treated with curative intent and with a documented negative viral load
  • History of systemic lupus erythematosus
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Schweizer, MD contact

206-606-6252

schweize@uw.edu

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Michael Schweizer, MD, 206-606-6252, schweize@uw.edu

    Michael Schweizer, MD

    Recruiting

Other trials in United States

About this study

Official title: Estrogen for Quality-of-Life and Immune Modulation in Prostate Cancer (EQUIP)

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.

Read the detailed 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 androgen receptor signaling inhibitor (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 tomography (CT) scan or magnetic resonance imaging (MRI), bone scan, dual x-ray absorptiometry (DEXA) scan and blood sample collection throughout the study.

COHORT 2: Patients receive estrogen via four transdermal patches twice weekly (BIW) on days 1, 4, 8, 12, 16, 20, 24 and 28 of cycle 1. Once castrate levels of testosterone are confirmed (< 20 ng/dL), patients receive three patches BIW on days 1, 4, 8, 12, 16, 20, 24 and 28 of cycles thereafter. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients whose testosterone levels rise above castrate levels at any time while receiving three patches BIW then increase to four patches BIW. Starting 4 weeks after initiation of transdermal estrogen, patients also receive ARSI per physician's choice for a minimum of 12 weeks in the absence of disease progression or unacceptable toxicity. 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.

Being tested
Androgen Receptor Pathway Inhibitor, Transdermal Estrogen, Bone Scan, Computed Tomography, Dual X-ray Absorptiometry
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Androgen Receptor Pathway InhibitorDrug

    Also called Androgen Receptor Signaling Inhibitor, AR Pathway Inhibitor, AR Signaling Inhibitor, AR Signaling Pathway Inhibitor

    Given per standard of care

  • Transdermal EstrogenDrug

    Also called Divigel, Estrodiol Gel, EstroGel

    Given via transdermal patch

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Dual X-ray AbsorptiometryProcedure or surgery

    Also called BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)

    Undergo DEXA scan

  • Gonadotropin-releasing Hormone AnalogBiological

    Also called GnRH Agonist, GnRH Analog, Gonadotropin-Releasing Hormone Agonist, Gonadotropin-Releasing Hormone Analogue

    Given per standard of care

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Survey AdministrationOther

    Ancillary studies

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

Study groups in NCT07466498
Study groupRoleWhat they receive
Cohort 1 (LHRH agonist/antagonist and ARSI)Active comparatorPatients 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 CT scan or MRI, bone scan, DEXA scan and blood sample collection throughout the study.
Receives: Drug: Androgen Receptor Pathway Inhibitor; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Dual X-ray Absorptiometry; Biological: Gonadotropin-releasing Hormone Analog; Procedure: Magnetic Resonance Imaging; Other: Survey Administration; Procedure: Biospecimen Collection
Cohort 2 (Estrogen and ARSI)ExperimentalPatients receive estrogen via four transdermal patches BIW on days 1, 4, 8, 12, 16, 20, 24 and 28 of cycle 1. Once castrate levels of testosterone are confirmed (< 20 ng/dL), patients receive three patches BIW on days 1, 4, 8, 12, 16, 20, 24 and 28 of cycles thereafter. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients whose testosterone levels rise above castrate levels at any time while receiving three patches BIW then increase to four patches BIW. Starting 4 weeks after initiation of transdermal estrogen, patients also receive ARSI per physician's choice for a minimum of 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, bone scan, DEXA scan and blood sample collection throughout the study.
Receives: Drug: Androgen Receptor Pathway Inhibitor; Drug: Transdermal Estrogen; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Dual X-ray Absorptiometry; Procedure: Magnetic Resonance Imaging; Other: Survey Administration; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mean daily hot flash score

    As measured by Mayo Clinic Hot Flash Daily score. Will determine the analysis end time as the final dose of the study drug or 12 weeks whichever occurs first (efficacy analysis) or the 12-week dose (effectiveness analysis). Will then calculate the difference between the first hot flash score after the analysis end time 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.

    Measured: From baseline to a minimum of 12 weeks combination therapy

Secondary outcomes (9)

  1. 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.

    Measured: From baseline to end of study visit, up to 2 years

  2. Bone mineral density

    Assessed from change in T-score (or Z-score) via dual energy x-ray absorptiometry.

    Measured: From baseline to end of study visit, up to 2 years

  3. Changes in metabolic parameters: Mean change in hemoglobin A1c

    Assessed via results of hemoglobin A1c.

    Measured: From baseline to end of study visit, up to 2 years

  4. 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].

    Measured: From baseline to end of study visit, up to 2 years

  5. Changes in sleep patterns and sleep quality

    Assessed via results of sleep questionnaire in combination with results of wearable sleep device to measure total sleep time, sleep onset latency and sleep efficiency.

    Measured: From cycle 1 to end of study visit, up to 2 years

  6. Incidence of adverse events

    Assessed according to Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 2 years

  7. Time to radiographic progression

    Assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (soft tissue metastases) and Prostate Cancer Working Group 3 criteria (bone metastases).

    Measured: From randomization to radiographic progression, up to 2 years

  8. Time to prostate specific antigen (PSA) progression

    Based on Prostate Cancer Working Group 3 criteria.

    Measured: From randomization to PSA progression, up to 2 years

  9. Changes in immune cell composition

    Change in neutrophil to lymphocyte ratio.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients in cohort 1 with a median daily hot flash score ≥ 6 after 12 weeks of therapy may cross-over to cohort 2.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07466498
Sponsor's protocol ID
RG1126186
Other IDs
NCI-2026-00800, FHIRB0021151
Status last verified
Oct 2026
First submitted
23 Feb 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Androgen Receptor Pathway Inhibitor, Transdermal Estrogen and Bone Scan in people with Castration-Sensitive Prostate Adenocarcinoma and Metastatic Castration-Sensitive Prostate Adenocarcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Schweizer, MD (206-606-6252, schweize@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean daily hot flash score (time frame: From baseline to a minimum of 12 weeks combination therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07466498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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