- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02376296
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
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
3-weekly docetaxel therapy (starting dose of 75 mg/m2)
Other Names:
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.
|
3-weekly docetaxel therapy (starting dose of 75 mg/m2)
Other Names:
Blood draws for determination of docetaxel plasma levels and exposure (AUC)
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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
February 1, 2015
Primary Completion (Actual)
February 10, 2018
Study Completion (Actual)
February 10, 2018
Study Registration Dates
First Submitted
February 18, 2015
First Submitted That Met QC Criteria
February 24, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on docetaxel
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaCompletedNon-Small Cell Lung Cancer (NSCLC)China
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Arog Pharmaceuticals, Inc.WithdrawnCarcinoma, Non-Small-Cell Lung
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungJapan
-
SanofiCompletedLung NeoplasmsFrance, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom
-
SanofiCompleted