Study on Standard Therapy With or Without Surgery or Radiation for Metastatic Prostate Cancer

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03678025

Provider View

This clinical trial is exploring whether adding surgery or radiation to standard treatment can help control prostate cancer that has spread to other parts of the body. The study aims to see if these additional treatments can reduce the risk of cancer growth or spread.

Patient Parameters

Program Overview

This phase III study is investigating how well standard treatment, with or without additional surgery or radiation, works for prostate cancer that has spread beyond the prostate. The goal is to determine if adding these treatments can lower the chances of the cancer growing or spreading.

Description

The main goal of this study is to compare the overall survival of patients with metastatic prostate cancer who receive standard treatment alone versus those who also receive surgery or radiation to remove or target the primary tumor.

Secondary goals include comparing survival rates in patients who undergo surgery, the rate of cancer symptoms worsening, and the time patients live without the cancer getting worse. The study also looks at how these treatments affect patients' quality of life, including urinary function and pain levels.

Participants will first receive one of six standard treatments for 22-28 weeks. These treatments may include hormone therapies like goserelin, leuprolide, or degarelix, and possibly chemotherapy with docetaxel. After this initial treatment, participants will be randomly assigned to continue with standard treatment alone or to add surgery or radiation therapy.

The study will follow participants for up to 8 years to monitor their health and the effectiveness of the treatments.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate adenocarcinoma (a type of prostate cancer).
  • Must have an intact prostate and no prior local treatment for prostate cancer.
  • Must show evidence of cancer spread on specific imaging tests within 42 days before starting treatment.
  • Must not have brain metastases.
  • Must have received no more than 28 weeks of standard treatment for metastatic prostate cancer.
  • Must not have shown cancer progression while on standard treatment.
  • Must have a complete physical exam and medical history within 28 days before joining the study.
  • Must have specific blood tests, including PSA and testosterone, within 28 days before joining the study.
  • Must not have other active cancers, except for certain skin cancers or early-stage cancers in remission.
  • Must be willing to participate in quality of life studies and provide tissue samples for future research.
  • Must understand the study and sign a consent form.
  • Must have no disease progression during the initial 28 weeks of treatment.
  • Must consult with a urologist and have surgically treatable disease.
  • Must not plan to receive certain chemotherapy drugs after randomization.
  • Must have resolved any side effects from initial treatment to a mild level before randomization.
  • Must have a PSA test and testosterone level below a certain threshold within 28 days before randomization.
  • Must have a good performance status, indicating they are fully active or able to carry out light work.

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