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Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Trelstar
Lupron
Zoladex
Sponsored by
Pharmatech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, Cancer, Trelstar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Urologic Specialists
  • Heritage Physician Group - Urology Department
  • California Oncology of the Central Valley
  • San Bernardino Urological Associates Medical Group
  • UroSearch
  • Scott A Slavis, MD, PC
  • Shaukat M Qureshi, MD
  • Brooklyn Heights Urology Associates
  • Jazrawi-Atallah, P.C.
  • Albemarle Urology Clinic, PA
  • Raj P. Chopra MD, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Trelstar

Lupron

Zoladex

Arm Description

Per prescribing information

Per prescribing information

Per prescribing information

Outcomes

Primary Outcome Measures

Maintenance of serum testosterone at or below castration level (50ng/dL)
Primary efficacy

Secondary Outcome Measures

Serum testosterone level at end of study
Secondary efficacy
Change in serum testosterone from baseline to end of study
Secondary efficacy
Incidence and severity of adverse events
Treatment tolerability

Full Information

First Posted
May 8, 2012
Last Updated
April 20, 2016
Sponsor
Pharmatech
Collaborators
Manyak, Michael, M.D., Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02749825
Brief Title
Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer
Official Title
A Multicenter, Randomized Clinical Investigation of Trelstar Versus Continued Therapy in Patients Receiving Lupron or Zoladex for Advanced Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Withdrawal of funding support
Study Start Date
September 2002 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmatech
Collaborators
Manyak, Michael, M.D., Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Cancer, Trelstar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trelstar
Arm Type
Experimental
Arm Description
Per prescribing information
Arm Title
Lupron
Arm Type
Active Comparator
Arm Description
Per prescribing information
Arm Title
Zoladex
Arm Type
Active Comparator
Arm Description
Per prescribing information
Intervention Type
Drug
Intervention Name(s)
Trelstar
Other Intervention Name(s)
Triptorelin pamoate
Intervention Description
As labeled
Intervention Type
Drug
Intervention Name(s)
Lupron
Other Intervention Name(s)
luprolide acetate for depot suspension
Intervention Description
As labeled
Intervention Type
Drug
Intervention Name(s)
Zoladex
Other Intervention Name(s)
goserelin acetate
Intervention Description
As labeled
Primary Outcome Measure Information:
Title
Maintenance of serum testosterone at or below castration level (50ng/dL)
Description
Primary efficacy
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Serum testosterone level at end of study
Description
Secondary efficacy
Time Frame
Week 12
Title
Change in serum testosterone from baseline to end of study
Description
Secondary efficacy
Time Frame
Baseline and week 12
Title
Incidence and severity of adverse events
Description
Treatment tolerability
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Michael Manyak, MD
Organizational Affiliation
Georege Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Urologic Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-5803
Country
United States
Facility Name
Heritage Physician Group - Urology Department
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
California Oncology of the Central Valley
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
San Bernardino Urological Associates Medical Group
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
UroSearch
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Scott A Slavis, MD, PC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Shaukat M Qureshi, MD
City
Pennsville
State/Province
New Jersey
ZIP/Postal Code
08070
Country
United States
Facility Name
Brooklyn Heights Urology Associates
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Jazrawi-Atallah, P.C.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Albemarle Urology Clinic, PA
City
Albemarle
State/Province
North Carolina
ZIP/Postal Code
28001
Country
United States
Facility Name
Raj P. Chopra MD, PC
City
Bloomsburg
State/Province
Pennsylvania
ZIP/Postal Code
17815
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.pharmatech.com
Description
Pharmatech - The Research Link website

Learn more about this trial

Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

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