Evaluate Recovery of Testosterone for Patients Using Eligard

NCT01136226 | Completed Phase 4 Results

• 1 other identifier: CURA-RT-001
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Serum Testosterone Recovery

  To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer

  6 mos

Secondary Outcomes (1)

• Safety Assessments

  6 months

Study Arms (1)

Eligard (TM)

OTHER

Eligard (TM) administered 22.5mg

Drug: Eligard (TM)

Interventions

Eligard (TM) DRUG

Eligard (TM) 22.5 mg administered at baseline and Month 3

Eligard (TM)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be outpatient, not hospitalized
• Male Patient between ages 50-80, inclusive
• Histologically/Cytologically graded adenocarcinoma of the prostate
• Must have T1, T2 or T3a adenocarcinoma of the prostate
• Must be a candidate for radiation therapy. Hormone refractory patients excluded
• WHO/ECOG score of 0,1 or 2

You may not qualify if:

• NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator.
• Used the following treatments for prostate Cancer
• \*immunotherapy \*chemotherapy \*External Beam Radiation \*brachytherapy \*hormonal therapy \*biological response modifiers
• Prior Prostate Surgery (excluding TUNA or TURP)
• Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs
• Use of Investigational Drug, Biologic or device within five half-lives of its physiological action or three months prior to base line, whichever is longer
• Over the counter or alternative medical therapies which have estrogenic or anti-androgenic effect
• uncontrolled CHF within 6 months to baseline
• Myocardial Infarct, coronary vascular procedure or Clinically SignificantCardiovascualr Disease within 6 months of baseline Visit
• Venous thrombosis with in 6 Months of Screening
• Uncontrolled Hypertension defined as \>170/100 or Symptomatic Hypotension within 3 months of Baseline
• Insulin dependant Diabetic Patients Must not administer in an anatomic region where they will receive Eligard.
• Drug or Alcohol Abuse 6 months prior to Baseline
• Other Serious Illness at the discretion of the Investigator
• Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose for 3 months prior to Baseline

Sponsors & Collaborators

• Chesapeake Urology Research Associates: lead
• Sanofi-Synthelabo: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

luprolide acetate gel depot

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Heather Thomas, Administrator
• Organization: Chesapeake Urology Research Associates

hthomas@cua.md

443.471.5742

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: October 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 24, 2018
• Results First Posted: July 16, 2013

Record last verified: 2018-09