Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

April 20, 2016 updated by: Pharmatech

A Multicenter, Randomized Clinical Investigation of Trelstar Versus Continued Therapy in Patients Receiving Lupron or Zoladex for Advanced Prostate Cancer

This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA.

Study Overview

Status

Status

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

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.

Detailed Description

Patients who are currently receiving Lupron or Zoladex will be consented and then randomized to receive either continued treatment with the drug they have been on, or will be randomized to Trelstar for a period of 3 months. At the end of that period, testosterone and prostate serum antigen (PSA) levels will be drawn and compared to their previous levels to determine if Trelstar is as effective as the previous treatment.

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.
Interventional

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.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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
    • Arizona
      • Tucson, Arizona, United States, 85712-5803
        • Arizona Urologic Specialists
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Heritage Physician Group - Urology Department
    • California
      • Fresno, California, United States, 93710
        • California Oncology of the Central Valley
      • San Bernardino, California, United States, 92404
        • San Bernardino Urological Associates Medical Group
    • Florida
      • Ocala, Florida, United States, 34470
        • UroSearch
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Scott A Slavis, MD, PC
    • New Jersey
      • Pennsville, New Jersey, United States, 08070
        • Shaukat M Qureshi, MD
    • New York
      • Brooklyn, New York, United States, 11201
        • Brooklyn Heights Urology Associates
      • Brooklyn, New York, United States, 11201
        • Jazrawi-Atallah, P.C.
    • North Carolina
      • Albemarle, North Carolina, United States, 28001
        • Albemarle Urology Clinic, PA
    • Pennsylvania
      • Bloomsburg, Pennsylvania, United States, 17815
        • Raj P. Chopra MD, PC

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

Description

Inclusion Criteria:

  • Advanced Prostate Cancer
  • Currently taking Lupron or Zoladex
  • Stable PSA
  • Baseline testosterone below castration level
  • Life expectancy > 6 months
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Signed, approved informed consent.

Exclusion Criteria:

  • Known hypersensitivity to any leuteinizing hormone releasing hormone (LHRH) agonist
  • Ongoing therapy with hyperprolactinemic agents
  • Antiandrogen therapy within 28 days prior to study start
  • Prior Orchiectomy, hypophysectomy or adrenalectomy
  • Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start
  • Use of any investigational agent 3 months prior to enrollment
  • Use of systemic corticosteroids within 28 days or during study
  • Other malignancies within 2 yrs prior to study start, except curatively treated skin cancers
  • Severe kidney or liver failure, based on adequate lab values
  • Other medical conditions which would be likely to interfere with compliance or completion of study requirements

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Trelstar
Per prescribing information
Drug: Trelstar
As labeled
Other Names:
  • Triptorelin pamoate
Active Comparator: Lupron
Per prescribing information
Drug: Lupron
As labeled
Other Names:
  • luprolide acetate for depot suspension
Active Comparator: Zoladex
Per prescribing information
Drug: Zoladex
As labeled
Other Names:
  • goserelin acetate

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
Maintenance of serum testosterone at or below castration level (50ng/dL)
Time Frame: 12 weeks
Primary efficacy
12 weeks

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
Serum testosterone level at end of study
Time Frame: Week 12
Secondary efficacy
Week 12
Change in serum testosterone from baseline to end of study
Time Frame: Baseline and week 12
Secondary efficacy
Baseline and week 12
Incidence and severity of adverse events
Time Frame: 12 weeks
Treatment tolerability
12 weeks

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.
Pharmatech

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.
Watson Pharmaceuticals
Manyak, Michael, M.D.

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: Michael Michael Manyak, MD, Georege Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
September 1, 2002

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.
May 1, 2006

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.
July 1, 2006

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).
May 8, 2012

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.
April 20, 2016

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.
April 25, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
April 25, 2016

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.
April 20, 2016

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.
May 1, 2012

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.
  • PUI-02809

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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