A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease (EFFECT)

March 7, 2017 updated by: Astellas Pharma Europe Ltd.

An Exploratory, Open Label, Single-arm Study to Evaluate the Effect of Eligard® 6-month on Biomarkers of Disease in Patients With Metastatic Prostate Cancer

The purpose of this study is to investigate the effect of the study medication (Eligard®) on cancer markers (in the blood) of prostate cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to explore the effect of Eligard® on the following prostate cancer biomarkers:

Testosterone in serum, Prostate Specific Antigen (PSA) in serum, Prostate Cancer Antigen (PCA3 score) in urine, PSA mRNA in blood/Peripheral Blood Mononuclear Cell (PBMC), PCA3 mRNA in blood/PBMC, Transmembrane protease, serine 2-Ets Related Gene (TMPRSS2-ERG) mRNA in blood/PBMC

A blood sample for RNA analysis will also be collected and stored for future investigation in patients giving specific informed consent.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands, 3435 CM
        • Site NL31005 St. Antonius ziekenhuis
      • Nijmegen, Netherlands, 6525 GA
        • Site NL31004 Radboudumc
      • Nijmegen, Netherlands, 6532 SZ
        • Site NL31001 Canisius-Wilhelmina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Confirmed metastatic prostate cancer for whom androgen deprivation therapy (ADT) is indicated.
  • Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening.
  • Serum PSA ≥ 5 ng/mL at screening.
  • Eastern Cooperative Oncology Group (ECOG) score of 0-2
  • A life expectancy of at least 12 months.
  • Is able to tolerate injection of study drug and comply with the study requirements.
  • Positive blood PSA mRNA at screening. A positive PSA mRNA in PBMCs (defined as exceeding the Limit of Detection [LoD] for the central lab assay, i.e. ≥ 10 copies per Polymerase Chain Reaction, PCR).

Exclusion Criteria:

  • History of bilateral orchidectomy.
  • History of any hormonal treatment/therapy with GnRH agonist, GnRH anti-agonist within 6 months of enrolment.
  • Treatment with anti-androgens (except where used to prevent testosterone flare up, starting up to 2 weeks prior to Eligard injection, according to local treatment guidelines), 5-α reductase inhibitors, estrogens and/or other any investigational hormone-derivative within 3 months of enrolment or 5-times the half-life, whichever is longer.
  • Any previous treatment with chemotherapy treatment for prostate cancer prior to the screening visit or within 6 months prior to screening for any other cancer.
  • Patients previously treated for cancer with hormonal therapy in whom treatment was stopped due to lack of efficacy, progression of the disease or lack of tolerability.
  • Previous treatments for cancer (including prostate cancer) within 6 months prior to enrolment: immunotherapy, external beam radiotherapy, brachytherapy, thermotherapy, or biological response modifiers (e.g. cytokines).
  • Known or suspected spinal cord compression or evidence of spinal metastases with risk of spinal compression.
  • Uni- or bilateral ureteric obstruction.
  • Requiring concomitant use of anti-androgens during the course of the study (except where used to prevent testosterone flare up, starting up to 2 weeks prior to Eligard injection and continuing for up to 3 weeks, according to local treatment guidelines).
  • Previous or concomitant malignancies at other sites except effectively treated non-melanoma skin cancer or an effectively treated malignancy that has been in remission for at least 5 years.
  • Major surgery within 2 months prior to enrolment.
  • Total bilirubin > 1.5 times the upper limit of normal (ULN) at screening. This will not apply to subjects with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with the sponsor.
  • Participation in any clinical study within ≤ 1 month prior to screening (or 5 half lives of the drugs under investigation, whichever is greater).
  • Not available for follow-up assessments or unable to comply with study requirements.
  • Known or suspected hypersensitivity to leuprorelin acetate, to other GnRH agonists or to any of the excipients of Eligard.
  • Male subjects who are intending to donate sperm within 9 months following the injection of Eligard

  • Male subjects and their female spouses/partners who are of childbearing potential and are NOT using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continuing for 9 months from the time of the Eligard injection. Acceptable forms include:

    • Established use of oral, injected or implanted hormonal methods of contraception.
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    • Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
  • Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, and hemoglobin < 5.6 mmol/L (9 g/dL) at screening.
  • Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times ULN at screening.
  • Creatinine > 177 μmol/L (2 mg/dL) at screening.
  • Albumin ≤ 30 g/L (3.0 g/dL) at screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm: Eligard
Single Arm
Drug: Eligard
Subcutaneous Injection
Other Names:
  • Leuprorelin acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline of Testosterone levels in serum
Time Frame: Baseline to 6 months
Baseline to 6 months
Changes from baseline of PSA level in serum
Time Frame: Baseline to 6 months
Baseline to 6 months
Changes from baseline of PCA3 score in urine
Time Frame: Baseline to 6 months
Baseline to 6 months
Changes from baseline of Number of PSA mRNA copies in blood/PBMC
Time Frame: Baseline to 6 months
Baseline to 6 months
Changes from baseline of Number of PCA3 mRNA copies in blood/PBMC
Time Frame: Baseline to 6 months
Baseline to 6 months
Changes from baseline of Number of TMPRSS2-ERG mRNA copies in blood/PBMC
Time Frame: Baseline to 6 months
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events from screening to the end of study visit (as reported by the investigator based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.3)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe Ltd.

Investigators

  • Study Chair: Clinical Study Manager, Astellas Pharma Europe Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGD-EC-005
  • 2012-000101-69 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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