Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients

February 15, 2022 updated by: Saladax Biomedical, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • UPMC CancerCenter - Beaver
      • Bethel Park, Pennsylvania, United States, 15102
        • UPMC CancerCenter - Upper St. Clair
      • Farrell, Pennsylvania, United States, 16121
        • UPMC CancerCenter - Horizon
      • Greensburg, Pennsylvania, United States, 15601
        • Arnold Palmer Cancer Center - Oakbrook
      • Greensburg, Pennsylvania, United States, 15601
        • Arnold Palmer Cancer Center
      • Greenville, Pennsylvania, United States, 16125
        • UPMC CancerCenter - Greenville
      • Indiana, Pennsylvania, United States, 15701
        • UPMC CancerCenter - Indiana
      • Johnstown, Pennsylvania, United States, 15901
        • UPMC CancerCenter at John P. Murtha Regional Cancer Center
      • McKeesport, Pennsylvania, United States, 15132
        • UPMC CancerCenter - Mckeesport
      • Monroeville, Pennsylvania, United States, 15146
        • UPMC CancerCenter - Monroeville
      • Mount Pleasant, Pennsylvania, United States, 15666
        • Arnold Palmer Medical Oncology - Mount Pleasant
      • New Castle, Pennsylvania, United States, 16105
        • UPMC CancerCenter - New Castle
      • Pittsburgh, Pennsylvania, United States, 15215
        • UPMC CancerCenter - St. Margaret
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC CancerCenter - Hillman Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC CancerCenter - Passavant HOA
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC CancerCenter - Passavant OHA
      • Seneca, Pennsylvania, United States, 16346
        • UPMC CancerCenter - Northwest
      • Uniontown, Pennsylvania, United States, 15401
        • UPMC CancerCenter - Uniontown
      • Washington, Pennsylvania, United States, 15301
        • UPMC CancerCenter - Washington
      • West Mifflin, Pennsylvania, United States, 15122
        • UPMC CancerCenter - Jefferson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Metastatic prostate cancer patients, either newly diagnosed or castrate resistant, who are about to start treatment with a 3-weekly docetaxel treatment regimen (starting dose of 75 mg/m2) within the University of Pittsburgh Medical Center (UPMC) Cancer Center network.

Description

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.
  • At least four weeks elapsed between prior surgery or prior radiotherapy and initiation of docetaxel therapy.
  • Radiograph-documented evidence of soft tissue or bony metastatic disease.
  • Must have adequate hematologic, hepatic and renal function as defined below:
  • Hematologic (minimal values): Absolute neutrophil count ≥ 1,500/mm3; Hemoglobin ≥ 10.0 g/dl; Platelet count ≥ 75,000/mm3
  • Hepatic Function: Total Bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); asparate transaminase (AST) and alanine transaminase (ALT) < 2 x institutional ULN
  • Suitable venous access and healthy enough (as determined by the treating physician) to provide whole blood sample.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
hormone naïve
Subjects with hormone naïve metastatic prostate cancer that have high-volume disease and have been on androgen deprivation therapy for less than 120 days prior to starting docetaxel therapy.
Drug: docetaxel
3-weekly docetaxel therapy (starting dose of 75 mg/m2)
Other Names:
  • Taxotere
Other: Blood draws
Blood draws for determination of docetaxel plasma levels and exposure (AUC)
castrate resistant
Subjects with castrate resistant prostate cancer (CRPC) [defined as having evidence of prostate specific antigen (PSA) progression despite androgen deprivation therapy] that have had at least four weeks elapse between the withdrawal of anti-androgens (Bicalutamide, Flutamide or Nilutamide) and the initiation of docetaxel therapy.
Drug: docetaxel
3-weekly docetaxel therapy (starting dose of 75 mg/m2)
Other Names:
  • Taxotere
Other: Blood draws
Blood draws for determination of docetaxel plasma levels and exposure (AUC)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Variability of docetaxel exposure
Time Frame: Up to 6 months after the initiation of docetaxel therapy
Blood will be drawn during the first six cycles of docetaxel therapy to determine the variability of docetaxel exposure.
Up to 6 months after the initiation of docetaxel therapy
Docetaxel treatment related toxicities
Time Frame: Up to 7 months after the initiation of docetaxel therapy
Determine the relationship between docetaxel plasma concentrations (i.e. exposure level) and the incidence of docetaxel related toxicities for identification of an optimal target docetaxel exposure range.
Up to 7 months after the initiation of docetaxel therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of growth factor usage
Time Frame: Up to 7 months after the initiation of docetaxel therapy
Determine relationship (if any) between growth factor usage and docetaxel exposure levels.
Up to 7 months after the initiation of docetaxel therapy
Number of days hospitalized for treatment of docetaxel related toxicities
Time Frame: Up to 7 months after the initiation of docetaxel therapy
Determine relationship (if any) between number of day hospitalized due to treatment related toxicities and docetaxel exposure levels.
Up to 7 months after the initiation of docetaxel therapy
Time to prostate specific antigen (PSA) progression
Time Frame: Up to 24 months after the initiation of docetaxel therapy
Determine relationship (if any) between the time to PSA progression and docetaxel exposure levels obtained during the first 6 cycles of treatment.
Up to 24 months after the initiation of docetaxel therapy
Tumor response as determined by imaging
Time Frame: Up to 7 months after the initiation of docetaxel therapy
Determine relationship (if any) between the tumor response as determined by imaging and docetaxel exposure levels obtained during the first 6 cycles of treatment.
Up to 7 months after the initiation of docetaxel therapy
Changes in quality of life
Time Frame: Up to 6 months after the initiation of docetaxel therapy
Determine relationship between changes in the quality of life (as measured using the FACT-P Questionnaire) and docetaxel exposure levels obtained during the first 6 cycles of treatment.
Up to 6 months after the initiation of docetaxel therapy
Overall survival
Time Frame: Up to 24 months after the initiation of docatexel therapy
Determine relationship between overall survival and docetaxel exposure levels obtained during the first 6 cycles of treatment.
Up to 24 months after the initiation of docatexel therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saladax Biomedical, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UPMC CancerCenter

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rahul A Parikh, MD, PhD, Upmc Cancercenter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBI-DTX-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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