Study on Surgery and Radiation Therapy for Recurrent Prostate Cancer

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03796767

Provider View

This clinical trial is exploring how well surgery and radiation therapy work together to treat prostate cancer that has returned or spread to other parts of the body. The study aims to see if these treatments can effectively control the cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining surgery and radiation therapy can better treat prostate cancer that has come back or spread. Radiation therapy uses high-energy beams to kill cancer cells and shrink tumors, while surgery, such as oligometastasectomy, removes cancer cells that have spread. Researchers hope that using both treatments together will be more effective for patients with recurrent or metastatic prostate cancer.

Description

The main goal of this study is to see how well the treatment works for prostate cancer that has spread to a limited number of areas (oligometastatic disease). Researchers will also look at other measures of treatment success, such as how long patients stay free from cancer progression and how long it takes for the cancer to come back. They will also assess the time until patients need additional hormone therapy and the rate of undetectable prostate-specific antigen (PSA) levels after treatment. The study will monitor the safety of the treatments and their impact on patients' quality of life over three years.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of prostate cancer.
  • Experienced a return of prostate cancer after initial treatment, with specific PSA levels indicating recurrence.
  • Have 10 or fewer cancer spots in lymph nodes or bones.
  • Cancer spread to lymph nodes must be limited to certain areas as shown by imaging tests.
  • Be a candidate for surgery if needed.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Agree to use condoms if not surgically sterile and have a partner who can become pregnant, starting from consent and continuing for 6 months after treatment.
  • Have recovered from any side effects of previous treatments to a manageable level.
  • Be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have cancer that has spread to the brain or other organs besides lymph nodes.
  • Currently receiving hormone therapy for prostate cancer.
  • Have another cancer that could interfere with the study.
  • Recently used certain medications like finasteride or dutasteride.
  • Have serious health conditions such as heart problems, uncontrolled high blood pressure, recent stroke or heart attack, or active infections.
  • Have severe liver problems.

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