Study on Estrogen to Improve Quality of Life for Men with Metastatic Hormone Sensitive Prostate Cancer

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT07466498

Provider View

This clinical trial is exploring whether adding estrogen to standard prostate cancer treatment can improve the quality of life for men with hormone-sensitive prostate cancer that has spread. The study compares estrogen with standard hormone therapy to see if it helps reduce symptoms like hot flashes and fatigue.

Patient Parameters

Program Overview

This study is testing if adding estrogen to the usual treatment for prostate cancer can help improve the quality of life for men whose cancer is sensitive to hormones and has spread to other parts of the body. Standard treatments lower hormone levels, which can cause side effects like hot flashes and fatigue. Estrogen might help reduce these symptoms. The study will compare two groups: one receiving standard hormone therapy and the other receiving estrogen with hormone therapy.

Description

In this study, participants are divided into two groups:

Group 1:

  • Patients receive standard hormone therapy (LHRH agonist or antagonist) as per approved guidelines.
  • After 4 weeks, they also receive an androgen receptor signaling inhibitor (ARSI) for at least 12 weeks.
  • If patients experience severe hot flashes, they may switch to Group 2.
  • Patients undergo regular scans and blood tests throughout the study.

Group 2:

  • Patients receive estrogen through a skin patch on specific days of each 28-day cycle.
  • After 4 weeks, they also receive ARSI for at least 12 weeks.
  • Patients undergo regular scans and blood tests throughout the study.

After completing the treatment, patients will have follow-up visits at 30 days and every 6 months for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide informed consent.
  • Age 18 years or older.
  • Confirmed diagnosis of prostate cancer.
  • Cancer must be newly diagnosed or have returned and spread.
  • No prior chemotherapy for hormone-sensitive prostate cancer.
  • No prior treatment with LHRH analogues or next-generation ARSIs.
  • Adequate blood counts and organ function.
  • ECOG performance status of 2 or less.
  • Life expectancy of at least 16 weeks.
  • Willing to comply with study procedures and visits.
  • At least one tumor that can be measured by scans.
  • Use of effective contraception for male patients and their partners during and after treatment.

Exclusion Criteria

  • Involvement in planning or conducting the study.
  • Other cancers unless treated and disease-free for 2 years.
  • Uncontrolled brain metastases or spinal cord compression.
  • Inappropriate for docetaxel chemotherapy.
  • Use of high-dose corticosteroids.
  • Planning to receive other cancer treatments.
  • Recent major surgery.
  • Serious uncontrolled medical conditions.
  • Allergies to study medications.
  • Active hepatitis B or C.
  • Conditions that interfere with study participation.
  • History of blood clots or heart issues within 5 years.
  • Risk of cardiovascular events with estrogen therapy.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.