Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

Pharmatech, Inc.

Status and phase: Terminated; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: Trelstar; Drug: Zoladex; Drug: Lupron

Study type: Interventional

Funder types: Industry

Identifiers

NCT02749825

PUI-02809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Trelstar

Experimental group

Description:

Per prescribing information

Treatment:

Drug: Trelstar

Lupron

Active Comparator group

Description:

Per prescribing information

Treatment:

Drug: Lupron

Zoladex

Active Comparator group

Description:

Per prescribing information

Treatment:

Drug: Zoladex