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Evaluate Recovery of Testosterone for Patients Using Eligard (Eligard)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Eligard (TM)

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Hypersensitivity to GnRH, GnRH agonists

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Eligard (TM)

Arm Description

Eligard (TM) administered 22.5mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety Assessments

Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire

Full Information

NCT ID

NCT01136226

First Posted

June 2, 2010

Last Updated

September 25, 2018

Sponsor

Chesapeake Urology Research Associates

Collaborators

Sanofi-Synthelabo

1. Study Identification

Unique Protocol Identification Number

NCT01136226

Brief Title

Evaluate Recovery of Testosterone for Patients Using Eligard

Acronym

Eligard

Official Title

A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Eligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chesapeake Urology Research Associates

Collaborators

Sanofi-Synthelabo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eligard (TM)

Arm Type

Other

Arm Description

Eligard (TM) administered 22.5mg

Intervention Type

Drug

Intervention Name(s)

Eligard (TM)

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum Testosterone Recovery

Description

Time Frame

6 mos

Secondary Outcome Measure Information:

Title

Safety Assessments

Description

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Hypersensitivity to GnRH, GnRH agonists

12. IPD Sharing Statement

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Evaluate Recovery of Testosterone for Patients Using Eligard

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