Prostate Cancer
Conditions
Keywords
Prostate, Cancer, Trelstar
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.
Sponsors
Manyak, Michael, M.D.
Watson Pharmaceuticals
Pharmatech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of serum testosterone at or below castration level (50ng/dL) | 12 weeks | Primary efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum testosterone level at end of study | Week 12 | Secondary efficacy |
| Change in serum testosterone from baseline to end of study | Baseline and week 12 | Secondary efficacy |
| Incidence and severity of adverse events | 12 weeks | Treatment tolerability |
Countries
United States
Outcome results
None listed