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Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients | Clinical Trials | Clareo Health

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Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients

Observational Study of Metastatic Prostate Cancer Subjects Receiving Docetaxel Therapy for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay

NCT02376296•Saladax Biomedical, Inc.

View on ClinicalTrials.gov

Summary

In this observational study, blood samples for pharmacokinetic (PK) testing will be collected from subjects with metastatic prostate cancer during their treatment with docetaxel. Plasma levels of docetaxel will be determined, and the subjects docetaxel exposure levels, determined as an area under the curve (AUC), will be retrospectively correlated with reports of toxicity, tumor response, quality of life, time to disease progression and overall survival to provide guidance on what the appropriate target range for docetaxel exposure should be for metastatic prostate cancer subjects receiving docetaxel therapy for their disease.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
•Male subjects 18 years of age or older.
•About to start a new line of treatment with docetaxel (75 mg/m2) in combination with prednisone.
•All subjects must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and good clinical practices (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to the beginning of specific study procedures.
•Prior surgical castration or concurrent use of an agent for chemical castration with a serum testosterone level \< 50 ng/dL.
•Subjects with hormone naïve metastatic prostate cancer, must have high-volume disease, defined as extra-nodal visceral disease or bone metastases with at least 4 bone lesions (one being outside of the vertebral column or pelvis).
•Subjects with hormone naïve high-volume metastatic prostate adenocarcinoma must have been on androgen deprivation therapy (including luteinizing hormone-releasing hormone (LHRH) agonist therapy, LHRH antagonist therapy, or surgical castration) for less than 120 days prior to starting docetaxel therapy.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
•For subjects with castrate resistant prostate cancer (CRPC), at least four weeks elapsed between withdrawal of anti-androgens (Bicalutamide, Flutamide or Nilutamide) and initiation of docetaxel therapy.
•For subjects with CRPC, at least four weeks elapsed between last administration of Abiraterone (Zytiga®) or Enzalutamide (Xtandi®) and initiation of docetaxel therapy.
+6 more criteria

Exclusion Criteria

•Any condition / concomitant disease not allowing chemotherapy with docetaxel, prednisone or required premedication for the treatment regimen.
•Serious concurrent disorders (active infection requiring intravenous antibiotics, unstable angina, uncompensated congestive heart failure (CHF), or hepatic failure) that, in the opinion of the investigator, would prevent the use of docetaxel and/or compromise the subject's ability to provide whole blood samples for participation in the study.
•Concurrent use of any non-FDA approved (i.e. investigational or experimental) anticancer agent(s) or within four (4) weeks of enrolling on the study.
•Pre-existing neuropathy ≥ grade 2 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.
•Individuals with known seropositivity for human immunodeficiency virus (HIV), hepatitis C virus, hepatitis B surface antigen, or syphilis.
•Unwilling or unable to follow protocol requirements or to provide informed consent.

Locations (20)

UPMC CancerCenter - Beaver

Beaver, Pennsylvania, United States

UPMC CancerCenter - Upper St. Clair

Bethel Park, Pennsylvania, United States

UPMC CancerCenter - Horizon

Farrell, Pennsylvania, United States

Arnold Palmer Cancer Center - Oakbrook

Greensburg, Pennsylvania, United States

Arnold Palmer Cancer Center

Greensburg, Pennsylvania, United States

UPMC CancerCenter - Greenville

Greenville, Pennsylvania, United States

UPMC CancerCenter - Indiana

Indiana, Pennsylvania, United States

UPMC CancerCenter at John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, United States

UPMC CancerCenter - Mckeesport

McKeesport, Pennsylvania, United States

UPMC CancerCenter - Monroeville

Monroeville, Pennsylvania, United States

Key Dates

Start Date

February 1, 2015

Primary Completion Date

February 10, 2018

Completion Date

February 10, 2018

Last Updated

February 17, 2022

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

docetaxel

DRUG

Blood draws

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients

Inclusion Criteria

Exclusion Criteria

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