Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Trelstar
* Drug: Lupron
* Drug: Zoladex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trelstar<br>Per prescribing information | Drug: Trelstar<br>* As labeled<br>* Other names: Triptorelin pamoate;|
| Active Comparator: Lupron<br>Per prescribing information | Drug: Lupron<br>* As labeled<br>* Other names: luprolide acetate for depot suspension;|
| Active Comparator: Zoladex<br>Per prescribing information | Drug: Zoladex<br>* As labeled<br>* Other names: goserelin acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of serum testosterone at or below castration level (50ng/dL) | Primary efficacy | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Cancer, Trelstar