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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

41

Phase

  • 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

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
Intervention / Treatment
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

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

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

Pharmatech

Collaborators

Watson Pharmaceuticals
Manyak, Michael, M.D.

Investigators

  • 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

September 1, 2002

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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