Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

University of Washington

Status: Enrolling

Conditions: Metastatic Malignant Neoplasm in the Bone; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Treatments: Drug: Radium Ra 223 Dichloride; Other: Questionnaire Administration; Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04489719

10370 (Other Identifier)

RG1006011

NCI-2020-04699 (Registry Identifier)

Details and patient eligibility

About

This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to study the role of a DNA repair pathway in prostate cancer, specifically in response to administration of radium-223, an FDA-approved drug known to cause DNA damage to cancerous cells. Understanding how defects in the DNA repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients.

Full description

OUTLINE:

Patients receive standard of care radium Ra 223 dichloride given by intravenous (IV) bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.

After completion of study, patients are followed up every 3 months for up to 5 years from the date of treatment completion.

Enrollment: 48 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must be >= 18 years of age
• Patient must have histopathologic diagnosis of prostate cancer
• Patient must have castration-resistant prostate cancer
• Patient must have radiographic evidence of bone metastasis
• Patients must be symptomatic from prostate cancer
• Patient must have plans to undergo treatment with radium-223
• Patient must have a PSA level >= 10 ng/mL
• Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening
• Patient must have anticipated survival > 3 months
• Patient must be willing and able to authorize consent
• Patient must be willing and able to comply with the protocol, including follow-up visits

Exclusion criteria

• Patient must not have visceral metastasis

• Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded

  * Bone-targeted only therapy (e.g. denosumab or zoledronic acid) will be allowed

• Patients who have received prior radium-223

• Patients who have received prior platinum containing chemotherapy

• Absolute neutrophil count (ANC) < 1.5 x 10^9/L

• Hemoglobin (HB) < 9 g/dL

• Platelets (PLT) < 100 x 10^9/L

• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Trial design

48 participants in 1 patient group

Observational (biospecimen collection)

Description:

Patients receive standard of care radium Ra 223 dichloride given by IV bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.

Treatment:

Procedure: Biospecimen Collection

Other: Questionnaire Administration

Drug: Radium Ra 223 Dichloride