Prostate Cancer Clinical Trial

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

Summary

This phase II 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.

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Full Description

OUTLINE:

Patients receive standard of care radium Ra 223 dichloride given by intravenous (IV) bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.

After completion of study, patients are followed up every 3 months for up to 5 years from the date of treatment completion.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

60

Study ID:

NCT04489719

Recruitment Status:

Recruiting

Sponsor:

University of Washington

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There are 4 Locations for this study

See Locations Near You

Johns Hopkins University
Baltimore Maryland, 21287, United States More Info
Phuoc T. Tran, MD
Principal Investigator
Bozeman Health Deaconess Hospital
Bozeman Montana, 59715, United States More Info
Ali Mclinnis
Contact
406-414-3746
[email protected]
Justin Thomas, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States More Info
Patrick Panlasigui
Contact
206-606-7486
[email protected]
Evan Y. Yu, MD
Principal Investigator
University of Wisconsin-Madison
Madison Wisconsin, 53705, United States More Info
Glenn Liu, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

60

Study ID:

NCT04489719

Recruitment Status:

Recruiting

Sponsor:


University of Washington

How clear is this clinincal trial information?

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