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

Launched by UNIVERSITY OF WASHINGTON · Jul 23, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how well a treatment called radium-223 works for men with advanced prostate cancer that has spread to the bones and is no longer responding to hormone therapy. Prostate cancer is the most common cancer among men and can be challenging to treat, especially when it becomes resistant to standard therapies. The researchers want to understand how changes in the way cancer cells repair their DNA might affect how well radium-223 works. By learning more about this, doctors hope to create better treatment plans for future patients.

To participate in this study, men must be at least 18 years old, have a confirmed diagnosis of prostate cancer that is no longer responding to hormone therapy, and show signs that the cancer has spread to their bones. They should also have specific levels of a blood marker called PSA and be experiencing symptoms from their cancer. Participants will receive radium-223 and will have regular follow-up visits to monitor their health. It's important to note that men with certain other health conditions or previous treatments may not be eligible to join this trial.

Gender

MALE

Eligibility criteria

• 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