Study on the Effects of Prostate Surgery and Hormone Therapy in Men with Newly Diagnosed Metastatic Prostate Cancer

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03456843

Provider View

This clinical trial is exploring how well prostate surgery combined with hormone therapy, with or without the chemotherapy drug docetaxel, works in treating men whose prostate cancer has spread to other parts of the body.

Patient Parameters

Program Overview

This study is testing whether removing the prostate through surgery, along with hormone therapy and possibly chemotherapy, can help treat men with prostate cancer that has spread beyond the prostate. Hormone therapy reduces the levels of male hormones that can promote cancer growth, while chemotherapy like docetaxel can kill cancer cells or stop them from growing. The study aims to see if this combination of treatments is more effective for patients.

Description

The main goal of this study is to see if combining prostate surgery with the best available hormone therapy can benefit men with newly diagnosed metastatic prostate cancer. Researchers want to find out if this approach can delay the progression of cancer, improve survival rates, and maintain quality of life. They are also interested in understanding the biological changes in the cancer cells.

Participants in the study will be randomly assigned to one of two groups:

  • Group 1: Participants will receive hormone therapy, with the option of adding the chemotherapy drug docetaxel, based on the doctor's decision.
  • Group 2: Participants will start with hormone therapy for at least one month, then undergo prostate surgery. They will continue hormone therapy and may receive docetaxel before surgery, depending on the doctor's advice.

After the treatment, participants will have follow-up visits every six months to monitor their health and cancer progression.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer that has spread to other parts of the body.
  • Evidence of cancer spread confirmed by imaging tests or biopsy.
  • Cancer stage M1a, M1b, or M1c, indicating spread to distant lymph nodes, bones, or other organs.
  • No previous local treatments for prostate cancer, such as radiation or cryotherapy.
  • Willing to provide informed consent to participate in the study.
  • Prostate can be surgically removed according to the surgeon.
  • Started or plans to start hormone therapy within six months before joining the study.
  • Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Blood tests show adequate levels for surgery, including hemoglobin, platelets, and liver enzymes.

Exclusion Criteria

  • Not willing to provide informed consent.
  • Prostate cancer cannot be surgically removed according to the surgeon.
  • Received hormone therapy for more than six months before joining the study.
  • Life expectancy of less than six months.
  • Active spinal cord compression.
  • History of blood clots in the veins or lungs within six months before joining the study.
  • Previous local treatments for prostate cancer.
  • Recent chemotherapy or radiotherapy for other conditions within three weeks before joining the study.

Get This Program In Your Inbox

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