RECRUITING

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

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

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.

Official Title

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

Quick Facts

Study Start:2021-04-16
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04489719

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
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be \>= 18 years of age
  2. * Patient must have histopathologic diagnosis of prostate cancer
  3. * Patient must have castration-resistant prostate cancer
  4. * Patient must have radiographic evidence of bone metastasis
  5. * Patients must be symptomatic from prostate cancer
  6. * Patient must have plans to undergo treatment with radium-223
  7. * Patient must have a PSA level \>= 10 ng/mL
  8. * Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening
  9. * Patient must have anticipated survival \> 3 months
  10. * Patient must be willing and able to authorize consent
  11. * Patient must be willing and able to comply with the protocol, including follow-up visits
  1. * Patient must not have visceral metastasis
  2. * Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded
  3. * Patients who have received prior radium-223
  4. * Patients who have received prior platinum containing chemotherapy
  5. * Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L
  6. * Hemoglobin (HB) \< 9 g/dL
  7. * Platelets (PLT) \< 100 x 10\^9/L
  8. * Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Contacts and Locations

Study Contact

Patrick Panlasigui
CONTACT
206-606-7486
ppanlas2@fredhutch.org

Principal Investigator

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

Study Locations (Sites)

Johns Hopkins University
Baltimore, Maryland, 21287
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Washington

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

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 Date2021-04-16
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2021-04-16
Study Completion Date2028-08-01

Terms related to this study

Keywords Provided by Researchers

  • Prostate

Additional Relevant MeSH Terms

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