Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castrati… (NCT04489719) | Clinical Trial Compass
RecruitingNot Applicable
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
United States48 participantsStarted 2021-04-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.