PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER

Study on Prostate Cancer Treatments with Surgery or Radiation

Recruiting
18 years - 100 years
All
1 Location

Brief description of study.

The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST), which is used to treat prostate cancer.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: PROSTATE CANCER
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease. Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound [HIFU], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1905016643 (S1802)

This study investigates the effects of adding prostate removal surgery or radiation therapy to standard systemic therapy for treating prostate cancer. Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The purpose of this study is to see how these additional treatments affect patients with prostate cancer.

Participants will undergo either surgery to remove the prostate or radiation therapy, in addition to receiving standard systemic therapy. Standard systemic therapy is a treatment that uses medication to target cancer cells throughout the body. The study will compare the outcomes of these different treatment arms to understand their effects.

  • Who can participate: Men with prostate cancer who have an intact prostate and have not received prior local therapy for prostate adenocarcinoma are eligible. Patients should not have known brain metastases, and if brain imaging is performed, it must show no disease.
  • Study details: Participants will receive either prostate removal surgery or radiation therapy along with standard systemic therapy. This study does not involve a placebo.

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