Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

Phase 4

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Lupron; Drug: Trelstar; Drug: Zoladex

• Registration Number: NCT02749825
• Lead Sponsor: Pharmatech

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 Timeline

• Study Start: 2002-09
• Primary Completion: 2006-05
• Study Completion: 2006-07
• Status Verified: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-25
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lupron	Lupron	Per prescribing information
Trelstar	Trelstar	Per prescribing information
Zoladex	Zoladex	Per prescribing information

Primary Outcome Measures

Name	Time	Method
Maintenance of serum testosterone at or below castration level (50ng/dL)	12 weeks	Primary efficacy

Secondary Outcome Measures

Name	Time	Method
Serum testosterone level at end of study	Week 12	Secondary efficacy
Incidence and severity of adverse events	12 weeks	Treatment tolerability
Change in serum testosterone from baseline to end of study	Baseline and week 12	Secondary efficacy

Trial Locations

Locations (11)

Jazrawi-Atallah, P.C.; 🇺🇸 Brooklyn, New York, United States

Albemarle Urology Clinic, PA; 🇺🇸 Albemarle, North Carolina, United States

Raj P. Chopra MD, PC; 🇺🇸 Bloomsburg, Pennsylvania, United States

Brooklyn Heights Urology Associates; 🇺🇸 Brooklyn, New York, United States

California Oncology of the Central Valley; 🇺🇸 Fresno, California, United States

San Bernardino Urological Associates Medical Group; 🇺🇸 San Bernardino, California, United States

Heritage Physician Group - Urology Department; 🇺🇸 Hot Springs, Arkansas, United States

Shaukat M Qureshi, MD; 🇺🇸 Pennsville, New Jersey, United States

UroSearch; 🇺🇸 Ocala, Florida, United States

Arizona Urologic Specialists; 🇺🇸 Tucson, Arizona, United States

Scott A Slavis, MD, PC; 🇺🇸 Las Vegas, Nevada, United States