Prostate CancerNCT02376296
Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients
An observational study of Prostate Cancer, run by Saladax Biomedical, Inc. at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel and Blood draws
- How many people
- 35 participants
- Where
- 20 sitesUnited States
- Study dates
- Feb 2015to 10 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
UPMC CancerCenter - Beaver
Beaver, Pennsylvania, 15009
UPMC CancerCenter - Upper St. Clair
Bethel Park, Pennsylvania, 15102
UPMC CancerCenter - Horizon
Farrell, Pennsylvania, 16121
Arnold Palmer Cancer Center - Oakbrook
Greensburg, Pennsylvania, 15601
Arnold Palmer Cancer Center
Greensburg, Pennsylvania, 15601
UPMC CancerCenter - Greenville
Greenville, Pennsylvania, 16125
UPMC CancerCenter - Indiana
Indiana, Pennsylvania, 15701
UPMC CancerCenter at John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
UPMC CancerCenter - Mckeesport
McKeesport, Pennsylvania, 15132
UPMC CancerCenter - Monroeville
Monroeville, Pennsylvania, 15146
Arnold Palmer Medical Oncology - Mount Pleasant
Mount Pleasant, Pennsylvania, 15666
UPMC CancerCenter - New Castle
New Castle, Pennsylvania, 16105
UPMC CancerCenter - St. Margaret
Pittsburgh, Pennsylvania, 15215
UPMC CancerCenter - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UPMC CancerCenter - Passavant HOA
Pittsburgh, Pennsylvania, 15237
UPMC CancerCenter - Passavant OHA
Pittsburgh, Pennsylvania, 15237
UPMC CancerCenter - Northwest
Seneca, Pennsylvania, 16346
UPMC CancerCenter - Uniontown
Uniontown, Pennsylvania, 15401
UPMC CancerCenter - Washington
Washington, Pennsylvania, 15301
UPMC CancerCenter - Jefferson
West Mifflin, Pennsylvania, 15122
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, Blood draws
- Keywords
- metastatic prostate cancer, castrate resistant prostate cancer, CRPC, hormone sensitive prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called Taxotere
3-weekly docetaxel therapy (starting dose of 75 mg/m2)
Blood drawsOther
Blood draws for determination of docetaxel plasma levels and exposure (AUC)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: docetaxel; Other: Blood draws | |
| 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. Receives: Drug: docetaxel; Other: Blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of docetaxel exposure
Blood will be drawn during the first six cycles of docetaxel therapy to determine the variability of docetaxel exposure.
Measured: Up to 6 months after the initiation of docetaxel therapy
Docetaxel treatment related toxicities
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.
Measured: Up to 7 months after the initiation of docetaxel therapy
Secondary outcomes (6)
Frequency of growth factor usage
Determine relationship (if any) between growth factor usage and docetaxel exposure levels.
Measured: Up to 7 months after the initiation of docetaxel therapy
Number of days hospitalized for treatment of docetaxel related toxicities
Determine relationship (if any) between number of day hospitalized due to treatment related toxicities and docetaxel exposure levels.
Measured: Up to 7 months after the initiation of docetaxel therapy
Time to prostate specific antigen (PSA) progression
Determine relationship (if any) between the time to PSA progression and docetaxel exposure levels obtained during the first 6 cycles of treatment.
Measured: Up to 24 months after the initiation of docetaxel therapy
Tumor response as determined by imaging
Determine relationship (if any) between the tumor response as determined by imaging and docetaxel exposure levels obtained during the first 6 cycles of treatment.
Measured: Up to 7 months after the initiation of docetaxel therapy
Changes in quality of life
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.
Measured: Up to 6 months after the initiation of docetaxel therapy
Overall survival
Determine relationship between overall survival and docetaxel exposure levels obtained during the first 6 cycles of treatment.
Measured: Up to 24 months after the initiation of docatexel therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion10 Feb 2018
- Study completion10 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saladax Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UPMC CancerCenter
- Responsible party
- Sponsor
- Investigators
- Rahul A Parikh, MD, PhD, Principal investigator, UPMC CancerCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376296
- Sponsor's protocol ID
- SBI-DTX-004
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2015
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Metastatic Prostate Cancer Subjects Receiving Docetaxel Therapy for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay
- ClinicalTrials.gov ID
- NCT02376296
- Acronym / sponsor ID
- SBI-DTX-004
- Conditions
- Prostate Cancer
- Keywords
- metastatic prostate cancer, castrate resistant prostate cancer, CRPC, hormone sensitive prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Saladax Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- UPMC CancerCenter
- Study start
- Feb 2015
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 10 Feb 2018 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hormone naïve | – | Drug: docetaxel, Other: Blood drawsSubjects 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. |
| castrate resistant | – | Drug: docetaxel, Other: Blood drawsSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxelAlso: Taxotere3-weekly docetaxel therapy (starting dose of 75 mg/m2) | Drug | castrate resistant, hormone naïve |
| Blood drawsBlood draws for determination of docetaxel plasma levels and exposure (AUC) | Other | castrate resistant, hormone naïve |
Primary outcome
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.
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.
6 secondary outcomes
Frequency of growth factor usage
Time frame: 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
Time to prostate specific antigen (PSA) progression
Time frame: 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
Changes in quality of life
Time frame: Up to 6 months after the initiation of docetaxel therapy
Overall survival
Time frame: Up to 24 months after the initiation of docatexel therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul A Parikh, MD, PhD principal investigator
UPMC CancerCenter
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Saladax Biomedical, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of docetaxel exposure (time frame: Up to 6 months after the initiation of docetaxel therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.