A Multicenter, Randomized Clinical Investigation of Trelstar Versus Continued Therapy in Patients Receiving Lupron or Zoladex for Advanced Prostate Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Pharmatech
- Enrollment
- 41
- Locations
- 11
- Primary Endpoint
- Maintenance of serum testosterone at or below castration level (50ng/dL)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Trelstar
Per prescribing information
Intervention: Trelstar (Drug)
Lupron
Per prescribing information
Intervention: Lupron (Drug)
Zoladex
Per prescribing information
Intervention: Zoladex (Drug)
Outcomes
Primary Outcomes
Maintenance of serum testosterone at or below castration level (50ng/dL)
Time Frame: 12 weeks
Primary efficacy
Secondary Outcomes
- Serum testosterone level at end of study(Week 12)
- Incidence and severity of adverse events(12 weeks)
- Change in serum testosterone from baseline to end of study(Baseline and week 12)