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)

This study has suspended participant recruitment.
(Study temporarily put on hold due to issues related to laboratory tests.)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01933022
First received: August 28, 2013
Last updated: January 21, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention Phase
Metastatic Prostate Cancer
Drug: Eligard
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Changes from baseline of Testosterone levels in serum [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline of PSA level in serum [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline of PCA3 score in urine [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline of Number of PSA mRNA copies in blood/PBMC [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline of Number of PCA3 mRNA copies in blood/PBMC [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline of Number of TMPRSS2-ERG mRNA copies in blood/PBMC [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm: Eligard
Single Arm
Drug: Eligard
Subcutaneous Injection
Other Name: Leuprorelin acetate

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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).
  • Serum PSA ≥ 5 ng/mL at screening.

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.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933022

Locations
Netherlands
Site: 31003
's-Hertogenbosch, Netherlands, 5200 ME
Site: 31002
Hengelo, Netherlands, 7555 DL
Site: 31005
Nieuwegein, Netherlands, 3435 CM
Site: 31001
Nijmegen, Netherlands, 6532 SZ
Site: 31004
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01933022     History of Changes
Other Study ID Numbers: EGD-EC-005, 2012-000101-69
Study First Received: August 28, 2013
Last Updated: January 21, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Astellas Pharma Inc:
Metastatic prostate cancer
Exploratory
Biomarkers
Eligard

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Leuprolide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 26, 2015