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

NCT01933022 | Terminated Phase 4

• 2 other identifiers: EGD-EC-0052012-000101-69
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Metastatic Prostate Cancer

Keywords

Exploratory; Biomarkers; Eligard; Metastatic prostate cancer

Outcome Measures

Primary Outcomes (6)

• Changes from baseline of Testosterone levels in serum

  Baseline to 6 months

• Changes from baseline of PSA level in serum

  Baseline to 6 months

• Changes from baseline of PCA3 score in urine

  Baseline to 6 months

• Changes from baseline of Number of PSA mRNA copies in blood/PBMC

  Baseline to 6 months

• Changes from baseline of Number of PCA3 mRNA copies in blood/PBMC

  Baseline to 6 months

• Changes from baseline of Number of TMPRSS2-ERG mRNA copies in blood/PBMC

  Baseline to 6 months

Secondary Outcomes (1)

• 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)

  6 months

Study Arms (1)

Single Arm: Eligard

OTHER

Single Arm

Drug: Eligard

Interventions

Eligard DRUG

Subcutaneous Injection

Also known as: Leuprorelin acetate

Single Arm: Eligard

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (3)

Site NL31005 St. Antonius ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Site NL31004 Radboudumc

Nijmegen, 6525 GA, Netherlands

Location

Site NL31001 Canisius-Wilhelmina Ziekenhuis

Nijmegen, 6532 SZ, Netherlands

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

luprolide acetate gel depot; Leuprolide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe Ltd.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: August 30, 2013
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

NL (3)