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Metastatic Prostate CancerPhase 4EFFECTNCT01933022

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

A Phase 4 study testing Eligard in people with Metastatic Prostate Cancer, run by Astellas Pharma Europe Ltd. at 3 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
Eligard
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
3 sitesNetherlands
Study dates
Aug 2014to Aug 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Site NL31005 St. Antonius ziekenhuis

    Nieuwegein, 3435 CM

  • Site NL31004 Radboudumc

    Nijmegen, 6525 GA

  • Site NL31001 Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

Other trials in Netherlands

About this study

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

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

Read the 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.

Being tested
Eligard
Keywords
Exploratory, Biomarkers, Eligard, Metastatic prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EligardDrug

    Also called Leuprorelin acetate

    Subcutaneous Injection

Study groups in NCT01933022
Study groupRoleWhat they receive
Single Arm: EligardOtherSingle Arm
Receives: Drug: Eligard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline of Testosterone levels in serum

    Measured: Baseline to 6 months

  2. Changes from baseline of PSA level in serum

    Measured: Baseline to 6 months

  3. Changes from baseline of PCA3 score in urine

    Measured: Baseline to 6 months

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

    Measured: Baseline to 6 months

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

    Measured: Baseline to 6 months

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

    Measured: Baseline to 6 months

Secondary outcomes (1)

  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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2013 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Why it stopped: Termination due to high current screen rate failure and unreliable PSA mRNA assay.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01933022
Sponsor's protocol ID
EGD-EC-005
Other IDs
2012-000101-69
Acronym
EFFECT
Status last verified
Mar 2017
First submitted
28 Aug 2013
Last updated
9 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Eligard in people with Metastatic Prostate Cancer, run by Astellas Pharma Europe Ltd. at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Termination due to high current screen rate failure and unreliable PSA mRNA assay.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline of Testosterone levels in serum (time frame: Baseline to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01933022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.

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