Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmatech
• Collaborators: Manyak, Michael, M.D.; Watson Pharmaceuticals
• Treatments: Goserelin; Leuprolide; Triptorelin Pamoate

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