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NCT04489719 · ClinicalTrials.gov registry record
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
A clinical trial of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by University of Washington.
- Recruiting
- Registry status
- 48
- Enrollment target
- 4
- Study locations
NCT04489719: Recruiting study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by University of Washington.
NCT04489719 is a study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is actively recruiting participants, run by University of Washington. The registered enrollment target is 48 participants, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (73% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04489719, a study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- 48 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
Response will be defined as having one or both of the following: confirmed prostate specific antigen (PSA) decline of \>= 30% from baseline AND/OR confirmed alkaline phosphatase (ALP) decline \>= 30% from baseline. Response is evaluated throughout the course of treatment until the post-radium-223 end of treatment laboratory studies. Confirmation of response by PSA and/or ALP requires a second consecutive value obtained \>= 2 weeks after the first with sustained \>= 30% decline. Characterization
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- DRUG Radium Ra 223 Dichloride
Study Locations (4)
Maryland
- Johns Hopkins University - Baltimore
Montana
- Bozeman Health Deaconess Hospital - Bozeman
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Wisconsin
- University of Wisconsin-Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-04-16 |
| Est. Completion | 2029-08-01 |
What NCT04489719 shows while recruiting
NCT04489719 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (73% lower).
The record links to 4 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT04489719 reports a single indexed study location in Maryland, Montana, Washington.
Frequently Asked Questions
What is clinical trial NCT04489719 about?
NCT04489719 is a clinical study titled "Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer". 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 ...
What is the current status of trial NCT04489719?
This trial is currently recruiting. The enrollment target is 48 participants. The study started on 2021-04-16. Estimated completion is 2029-08-01.
What conditions does trial NCT04489719 study?
This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone.
What interventions are being tested in trial NCT04489719?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Radium Ra 223 Dichloride (DRUG).
Who is sponsoring clinical trial NCT04489719?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04489719 being conducted?
This trial has 4 study locations across Maryland, Montana, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IVB Prostate Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04489719's enrollment target sits among peer trials
48 27th of 45 higher than 18 of 45 other Stage IVB Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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