Study on Radium-223 for Prostate Cancer with Rising PSA Levels

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04206319

Provider View

This clinical trial is exploring the use of Radium-223 to treat prostate cancer in men whose PSA levels are rising after surgery or radiation, even though no cancer is visible on standard scans. The study focuses on how Radium-223 affects the immune system and PSA levels.

Patient Parameters

Program Overview

This study is investigating whether Radium-223, a treatment that uses radiation to target cancer cells, can help men with prostate cancer whose PSA levels are increasing after surgery or radiation. These men show no visible cancer on regular CT or bone scans, but have positive results on PET scans indicating cancer in the bones. The main goal is to see how Radium-223 affects the immune system, with a secondary focus on its impact on PSA levels and imaging results.

Description

Radium-223 is being tested as a potential treatment for men with prostate cancer who have rising PSA levels after surgery or radiation, but no visible cancer on standard imaging tests. This condition is known as biochemically recurrent prostate cancer. Radium-223 has shown promise in treating advanced prostate cancer by improving survival rates and may also enhance the immune system's ability to fight cancer.

The study will involve men who have had surgery or radiation for prostate cancer but now have rising PSA levels. Participants will receive Radium-223 through an IV every four weeks for up to six cycles. During the study, participants will undergo various tests, including blood and urine tests, heart function tests, and imaging scans. They will also complete quality of life surveys and provide stool samples.

After completing the treatment, participants will have follow-up visits every six weeks for the rest of their lives to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 and older with a confirmed diagnosis of prostate cancer.
  • Rising PSA levels after surgery or radiation, with no visible cancer on CT or bone scans.
  • Positive PET scan results indicating cancer in the bones, but not in organs (lymph nodes are allowed).
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • No other active cancers within the past three years, except for certain skin cancers or bladder cancer in situ.
  • Willingness to use effective birth control during and after the study to prevent harm to a potential pregnancy.

Exclusion Criteria

  • Men with weakened immune systems due to HIV or other immune disorders.
  • Positive tests for hepatitis B or C.
  • Recent use of systemic corticosteroids or certain medications that affect PSA levels.
  • History of chemotherapy or treatment with certain radioactive drugs.
  • Recent major surgery or participation in another clinical trial.
  • PET scan results indicating cancer in organs other than bones.

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