RECRUITING

Radium-223 in Biochemically Recurrent Prostate Cancer

Conditions

Biochemical Recurrent Prostate Cancer Immune Response Isotope PSA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Trial of Radium-223 in Biochemically Recurrent Prostate Cancer

Quick Facts

Study Start:2020-09-22

Study Completion:2027-11-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04206319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 parameters (within 16 days before treatment initiation) * Adequate renal function defined by eGFR within normal as predicted by the CKD-EPI equation (\>= 50 mL/min/1.73m\^2) or by measure o f creatinine clearance from 24-hour urine collection. * No other active malignancies within 36 months of treatment initiation (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) * Participants must be \>=18 years old. Currently, no dosing or adverse event data is available on the use of radium in participants \< 18 years of age; therefore, only adults are included in this study. * Ability of subject to understand and the willingness to sign a written informed consent document. * The effects radium-223 on the developing human fetus are unknown but based on the mechanism of action, radium-223 has the potential to cause fetal harm. For this reason, men must agree to use condoms for the duration of study therapy and at least 6 months	* Participants with immunocompromised status due to Human Immunodeficiency Virus (HIV) infection or other immunodeficiency diseases because this is a trial with a primary endpoint looking at immune response, requiring functional immune systems. * Participants who test positive for HBV or HCV. * Chronic administration (defined as daily or every other day for continued use \> 14 days) of systemic corticosteroids within 28 days of treatment initiation. Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, intraarticular, and topical agents) is allowed. * Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g. corneal transplant, hair transplant). * Serious intercurrent medical illness that, in the judgement of the investigator, would interfere with participant's ability to carry out the treatment program. * Subjects required other medications known to alter PSA including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative therapies (e.g., phytoestrogens and saw palmetto). * History of prior chemotherapy. * History of prior systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium 223 dichloride). * Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) of treatment initiation. * Major surgery within 28 days prior to treatment initiation. * PET scan findings suggesting visceral disease.

Inclusion Criteria

Exclusion 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 parameters (within 16 days before treatment initiation)
* Adequate renal function defined by eGFR within normal as predicted by the CKD-EPI equation (\>= 50 mL/min/1.73m\^2) or by measure o f creatinine clearance from 24-hour urine collection.
* No other active malignancies within 36 months of treatment initiation (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder)
* Participants must be \>=18 years old. Currently, no dosing or adverse event data is available on the use of radium in participants \< 18 years of age; therefore, only adults are included in this study.
* Ability of subject to understand and the willingness to sign a written informed consent document.
* The effects radium-223 on the developing human fetus are unknown but based on the mechanism of action, radium-223 has the potential to cause fetal harm. For this reason, men must agree to use condoms for the duration of study therapy and at least 6 months

* Participants with immunocompromised status due to Human Immunodeficiency Virus (HIV) infection or other immunodeficiency diseases because this is a trial with a primary endpoint looking at immune response, requiring functional immune systems.
* Participants who test positive for HBV or HCV.
* Chronic administration (defined as daily or every other day for continued use \> 14 days) of systemic corticosteroids within 28 days of treatment initiation. Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, intraarticular, and topical agents) is allowed.
* Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g. corneal transplant, hair transplant).
* Serious intercurrent medical illness that, in the judgement of the investigator, would interfere with participant's ability to carry out the treatment program.
* Subjects required other medications known to alter PSA including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative therapies (e.g., phytoestrogens and saw palmetto).
* History of prior chemotherapy.
* History of prior systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium 223 dichloride).
* Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) of treatment initiation.
* Major surgery within 28 days prior to treatment initiation.
* PET scan findings suggesting visceral disease.

Contacts and Locations

Study Contact

Amy R Hankin, P.A.-C

CONTACT

(240) 858-3149

amy.hankin@nih.gov

Ravi A Madan, M.D.

CONTACT

(301) 480-7168

rm480i@nih.gov

Principal Investigator

Ravi A Madan, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Ravi A Madan, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-22

Study Completion Date2027-11-15

Study Record Updates

Study Start Date2020-09-22

Study Completion Date2027-11-15

Terms related to this study

Keywords Provided by Researchers

Immune Response
Isotope
PSA

Additional Relevant MeSH Terms

Biochemical Recurrent Prostate Cancer