Active — Not RecruitingPhase 2

Radium-223 in Biochemically Recurrent Prostate Cancer

United States19 participantsStarted 2020-09-22

Plain-language summary

Background: Some men who have been treated for localized prostate cancer with surgery or radiation still show signs of the disease in their blood. This is called biochemically recurrent prostate cancer. Radium-223 is a small molecule. It uses radiation to kill cancer cells and improves survival in advanced prostate cancer. Researchers want to see if it can treat prostate cancer and induced immune changes earlier in the disease when the cancer is only detectable by prostate specific antigen (PSA) in the blood. Objective: To learn how Radium-223 affects men with rising PSA but no evidence of cancer on conventional CT or bone scan, but positive findings on PET or molecular imaging in the bones. The primary focus is impact on the immune system with secondary focus on impact on PSA and imaging. Eligibility: Men ages 18 and older with prostate cancer who have had surgery and/or radiation, but their PSA is rising even though no disease is visible on routine imaging scans (CT or bone scans). Patients are required to have PET or molecular imaging findings in bones, but not organs (lymph nodes are allowed). Design: Participants will be screened with a medical history and physical exam. Their ability to do normal tasks will be reviewed. They will give tissue samples or a report from their doctor about their cancer. They will have blood and urine tests. They will have an electrocardiogram to measure heart function. They will have a scan of their chest and abdomen using radiation or magnetic resonance imaging. They will have a bone scan with injection of Tc99. They will have a positron emission tomography scan with intravenous (IV) injection of 18F-NaF. Participants will get Radium-223 by IV. For this, a small plastic tube is put into an arm vein. Radium-223 will be given on Day 1 of each cycle (1 cycle = 4 weeks) for up to 6 cycles. Participants will repeat the screening tests during the study. They will also complete Quality of Life Surveys and give stool samples. After treatment, participants will have long-term follow-up every 6 weeks for the rest of their lives.

Who can participate

Age range18 Years – 120 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Histopathological confirmation of prostate adenocarcinoma confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, or Walter Reed National Military Medical Center prior to enrollment. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease. * Biochemical progression after definitive surgery or radiation define as follows: * Participants must have a detectable PSA * Negative CT scan/MRI and Tc99 bone scan for metastatic prostate cancer. (Only Tc99 will be used to detect bone lesions, CT/MRI would be used to detect soft tissue lesions) * Presence of findings on PET scan (i.e., NaF PET scan) suspicious for metastatic prostate cancer in bone. Note: while lymph node findings would be allowed and provide the opportunity for the assessment of any abscopal effects, PET scan findings suggesting visceral disease will be excluded. * Testosterone \>= 100 ng/dL * ECOG performance status of 0 1 * Recovery from acute toxicity related to prior therapy, including surgery and radiation, (defined as no toxicity \>= grade 2). * Hematological eligibility parameters (within 16 days before treatment initiation): * Granulocyte count \>= 3,000/mm\^3 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hgb \>= 10 g/dL * Hepatic function eligibility par…

What they're measuring

changes in immune cell populations

Timeframe: 6 months

Trial details

NCT IDNCT04206319

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2026-02-10