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

Description

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.

Conditions

Castration-Resistant Prostate CarcinomaMetastatic Malignant Neoplasm in the BoneMetastatic Prostate CarcinomaStage IVB Prostate Cancer AJCC v8
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Related Conditions:

Castration-Resistant Prostate CarcinomaMetastatic Malignant Neoplasm in the BoneMetastatic Prostate CarcinomaStage IVB Prostate Cancer AJCC v8

Study Overview

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Study Details

Study overview

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.

The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer

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

Condition
Castration-Resistant Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Bozeman

Bozeman Health Deaconess Hospital, Bozeman, Montana, United States, 59715

Seattle

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States, 98109

Madison

University of Wisconsin-Madison, Madison, Wisconsin, United States, 53705

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Patient must not have visceral metastasis
  • * Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

Evan Y. Yu, MD, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

2028-08-01