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

Clinicaltrials.gov ID: NCT04489719
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 48

Conditions

Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

Drugs

Radium Ra 223 Dichloride

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.

Detailed 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.

Locations

3 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Evan Y. Yu, MD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Evan Y. Yu, MD

Status

  • RECRUITING

Contact Person

  • Glenn Liu, MD

Principal Investigator

  • Evan Y. Yu, MD

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 Plan

Observational (biospecimen collection)

Patients receive standard of care radium Ra 223 dichloride given by 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.

  • PROCEDURE:

    Biospecimen Collection

    Description:

    Undergo collection of blood samples
  • OTHER:

    Questionnaire Administration

    Description:

    Ancillary studies
  • DRUG:

    Radium Ra 223 Dichloride

    Description:

    Given IV

Outcome Measures

Primary Outcome Measures

Response rate

Time Frame: Up to 1 year

Secondary Outcome Measures

Response rate

Time Frame: Up to 1 year

Response rate in those with previous PARP inhibitor therapy

Time Frame: Up to 1 year

Overall survival

Time Frame: Up to 5 years

Number of radium Ra 223 dichloride

Time Frame: Up to 6 months

Pain assessment

Time Frame: Up to 1 year

Analgesic usage

Time Frame: Up to 1 year

Quality of life (FACT-P survey)

Time Frame: Up to 1 year

Incidence of adverse events

Time Frame: Up to 1 year

Response rate

Time Frame: Up to 1 year

Timeline

  • Last Updated
    August 19, 2024
  • Start Date
    July 28, 2020
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    August 1, 2028

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