Clinical trial for Castration-Sensitive Prostate Adenocarcinoma
Official title Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
ClinicalTrials.gov ID: NCT07466498
What this study is testing
What is Androgen Receptor Pathway Inhibitor?
An investigational drug being studied as part of a combination therapy for castration‑sensitive prostate adenocarcinoma. It is designed to block androgen receptor signaling, which can help stop tumor cell growth.
Also referred to as AR Pathway Inhibitor, AR Signaling Inhibitor, ARPI, ARSI.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether adding transdermal estrogen to standard treatment can improve symptoms like hot flashes, fatigue, and bone health compared with standard therapy alone.
- Who it's for
- Men who have newly diagnosed or recurrent metastatic hormone‑sensitive prostate cancer.
- What's involved
- Participants will be given either an estrogen skin patch plus an androgen‑receptor blocker or the usual hormone‑lowering injection plus the same blocker, and will complete quality‑of‑life questionnaires and routine check‑ups.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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)...
- No prior chemotherapy for the treatment of hormone sensitive prostate cancer
You likely can't join if
- Involvement in the planning and/or conduct of the study
- Other malignancy unless curatively treated with no evidence of disease for ≥ 2 years.
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required.
- 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
See the full eligibility 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.).
- 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...
- 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.
- 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...
- 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.
- 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.
- 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...
- 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...
- Excluded due to increased risk of cardiovascular events with estradiol supplementation
The study team makes the final eligibility decision.
Where it is enrolling
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.