Clinical trial NCT02376296: Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients
Official title: Observational Study of Metastatic Prostate Cancer Subjects Receiving Docetaxel Therapy for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: metastatic prostate cancer
castrate resistant prostate cancer
CRPC
hormone sensitive prostate cancer
Lead sponsor: Saladax Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: UPMC CancerCenter
First posted: 2015-03-03
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 criteria: 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.

Primary outcomes:
measure: Variability of docetaxel exposure
timeFrame: Up to 6 months after the initiation of docetaxel therapy
measure: Docetaxel treatment related toxicities
timeFrame: Up to 7 months after the initiation of docetaxel therapy
Secondary outcomes:
measure: Frequency of growth factor usage
timeFrame: Up to 7 months after the initiation of docetaxel therapy
measure: Number of days hospitalized for treatment of docetaxel related toxicities
timeFrame: Up to 7 months after the initiation of docetaxel therapy
measure: Time to prostate specific antigen (PSA) progression
timeFrame: Up to 24 months after the initiation of docetaxel therapy
measure: Tumor response as determined by imaging
timeFrame: Up to 7 months after the initiation of docetaxel therapy
measure: Changes in quality of life
timeFrame: Up to 6 months after the initiation of docetaxel therapy
measure: Overall survival
timeFrame: Up to 24 months after the initiation of docatexel therapy
Other outcomes:
Locations:
city: Beaver
country: United States
facility: UPMC CancerCenter - Beaver
state: Pennsylvania
city: Bethel Park
country: United States
facility: UPMC CancerCenter - Upper St. Clair
state: Pennsylvania
city: Farrell
country: United States
facility: UPMC CancerCenter - Horizon
state: Pennsylvania
city: Greensburg
country: United States
facility: Arnold Palmer Cancer Center - Oakbrook
state: Pennsylvania
city: Greensburg
country: United States
facility: Arnold Palmer Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: UPMC CancerCenter - Greenville
state: Pennsylvania
city: Indiana
country: United States
facility: UPMC CancerCenter - Indiana
state: Pennsylvania
city: Johnstown
country: United States
facility: UPMC CancerCenter at John P. Murtha Regional Cancer Center
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC CancerCenter - Mckeesport
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC CancerCenter - Monroeville
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Arnold Palmer Medical Oncology - Mount Pleasant
state: Pennsylvania
city: New Castle
country: United States
facility: UPMC CancerCenter - New Castle
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC CancerCenter - St. Margaret
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC CancerCenter - Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC CancerCenter - Passavant HOA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC CancerCenter - Passavant OHA
state: Pennsylvania
city: Seneca
country: United States
facility: UPMC CancerCenter - Northwest
state: Pennsylvania
city: Uniontown
country: United States
facility: UPMC CancerCenter - Uniontown
state: Pennsylvania
city: Washington
country: United States
facility: UPMC CancerCenter - Washington
state: Pennsylvania
city: West Mifflin
country: United States
facility: UPMC CancerCenter - Jefferson
state: Pennsylvania
Study officials:
affiliation: UPMC CancerCenter
name: Rahul A Parikh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: