Investigating DNA Repair and Radium-223 in Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines the effectiveness of radium-223 in treating patients with castration-resistant prostate cancer that has metastasized to the bones. It focuses on understanding how alterations in DNA repair pathways may influence the response to this treatment. Patients will receive radium-223 every four weeks for up to six cycles, with blood samples collected periodically to monitor their condition. Following treatment, participants will be followed for up to five years to assess long-term outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Fred Hutch/University of Washington Cancer Consortium
  Seattle, Washington, United States Recruiting
• University of Wisconsin-Madison
  Madison, Wisconsin, United States Recruiting
• Bozeman Health Deaconess Hospital
  Bozeman, Montana, United States Completed

Study contacts

• Principal investigator: Evan Y. Yu, MD — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Jane Romani
• Email: jromani@fredhutch.org
• Phone: 206-606-1909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.