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Prostate CancerPhase 3NCT00128531

Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

A Phase 3 study testing leuprolide acetate in people with Prostate Cancer, run by GP-Pharm at 28 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
leuprolide acetate
How many people
120 participants
Where
28 sitesin 9 countries
Study dates
Sep 2005to Nov 2007
Phase
Phase 3
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

  • Males >/= 18 years of age, with histologically proven carcinoma of the prostate, who might benefit from medical androgen deprivation therapy
  • Life expectancy of at least 1 year
  • World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2
  • Adequate renal function at screening as defined by serum creatinine </= 1.6 times the ULN (upper limit of normal) for the clinical laboratory
  • Adequate and stable hepatic function as defined by bilirubin </= 1.5 times the ULN and transaminases (i.e. SGOT, SGPT) </= 2.5 times the ULN for the clinical laboratory at screening
  • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
  • Signed written informed consent prior to inclusion in the study

Who cannot join

  • Evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
  • Evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
  • Evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
  • Excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
  • Testosterone levels < 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site
  • Previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibody therapies, tumor-vaccines), biological response modifiers (e.g. cytokines) within 3 months of baseline
Show all 30Show fewer
  • Previous hormonal therapy for treatment of prostate cancer, such as luteinising hormone-releasing hormone (LHRH) analogues (e.g. Lupron®, Zoladex®, etc.) [no wash-out allowed]
  • Previous treatment with androgen receptor (AR) blockers, such as Casodex®, Fugerel®, Megace®, Androcur® (no wash-out allowed)
  • Previous orchiectomy, adrenalectomy or hypophysectomy
  • Previous prostatic surgery (e.g. radical prostatectomy, transurethral resection of the prostate [TUR-P]) within 2 weeks of baseline
  • Previous local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeks of baseline
  • Any investigational drug within 5 half-lives of its physiological action or 3 months (whichever is longer) before baseline
  • Administration of 5-alpha-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 3 months before baseline
  • Over-the-counter (OTC) or alternative medical therapies which have an estrogenic or anti-androgenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, dehydroepiandrosterone [DHEA]) within the 3 months before baseline
  • Hematological parameters (RBC, total and differential WBC count, platelet count, hemoglobin, hematocrit) outside 20% of the upper or lower limits of normal (ULN, LLN) for the clinical laboratory at screening
  • Co-existent malignancy, according to the Investigator's opinion
  • Uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft) or significant symptomatic cardiovascular disease(s) within 6 months before baseline; resting uncontrolled hypertension: (>/= 160/100 mmHg) or symptomatic hypotension within 3 months before baseline
  • Venous thrombosis within 6 months of baseline
  • Insulin-dependent diabetes mellitus
  • History of drug and/or alcohol abuse within 6 months of baseline
  • Serious concomitant illness(es) or disease(s) [e.g., hematological, renal, hepatic, respiratory, endocrine, psychiatric] that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol
  • Patients receiving anticoagulants who have prothrombin and partial thromboplastin times outside of the normal range for the laboratory assays; patients who are on anticoagulation or antiplatelet medications (e.g. dipyridamole, ticlopidine, warfarin derivatives) who are not receiving a stable dose for 3 months before baseline; patients who are receiving warfarin-derivative anticoagulants who do not have an International Normalized Ratio (INR) in the therapeutic range for the clinical indication for which the anticoagulant has been prescribed.
  • Blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients (see earlier exclusion [9]; please note that these patients should not be included in the pharmacokinetic [PK] group)
  • Known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation
  • History of the following prior to the study:
  • immunization (within 4 weeks of baseline);
  • flu shots (within 2 weeks of baseline);
  • anaphylaxis;
  • skin disease which would interfere with injection site evaluation;
  • dermatographism will be documented at screening and followed up while on treatment.

Trial locations and contacts

28 sites in 9 countries.

28 sites in 9 countries

United States15 sites

  • Desert Oasis Cancer Center

    Casa Granda, Arizona, 85222

  • Southwest Florida Urologic Associates

    Fort Myers, Florida, 33907

  • AccuMed Research Associates

    Garden City, New York, 11530

  • Urological Surgeons of Long Island

    Garden City, New York, 11530

  • Hamilton Urology, P.A.

    Hamilton, New Jersey, 08690

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • Hudson Valley Urology

    Kingston, New York, 12401

  • Lawrenceville Urology

    Lawrenceville, New Jersey, 08648

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates, PC

    Nashville, Tennessee, 37209

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34652

  • Hudson Valley Urology

    Poughkeepsie, New York, 12601

  • Lakeside Urology

    Saint Joseph, Michigan, 49085

  • Florida Urology Specialists

    Sarasota, Florida, 34237

  • Regional Urology

    Shreveport, Louisiana, 71106

Other trials in United States

Czechia4 sites

  • Urocentrum Praha

    Prague, 120 00

  • Charles University, Clinic of Urology

    Prague

  • Urology Department, Hviezdoslavova

    Prague

  • Masaryk Hospital, Urology Dept.

    Ústí nad Labem, 401 13

Other trials in Czechia

Hungary2 sites

  • Department of Urology, Semmelweis University

    Budapest, H-1082

  • Department of Urology, Medical School, University of Pécs

    Pécs, H-7621

Other trials in Hungary

Italy2 sites

  • Department of Urology, General Hospital of Bolzano

    Bolzano, 39100

  • Sexual Medicine Unit and Urology, Università Vita Salute San Raffaele Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20132

Other trials in Italy

Austria1 site

  • Department of Urology, Vienna University Medical School

    Vienna, A-1090

Other trials in Austria

Germany1 site

  • Department of Urology, Technical University of Dresden

    Dresden, 01307

Other trials in Germany

Slovakia1 site

  • Department of Urology, Jessenius Faculty of Medicine, Comenius University

    Martin

Other trials in Slovakia

Spain1 site

  • Institut Català d'Oncologia, Hospital Duran I Reynals, Servicio de Oncologia Medica

    Barcelona, 08907

Other trials in Spain

United Kingdom1 site

  • Royal Free Hospital and School of Medicine

    London, NW3 2QG

Other trials in United Kingdom

About this study

Official title: Efficacy and Safety of a New Leuprolide Acetate 3.75 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients

The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.

Read the detailed description

Other assessments include evaluation of main leuprolide PK parameters in 12 subjects after administration of 3 doses.

Study Design:

This will be a multi-center, open-label, fixed investigation of six monthly dosages of leuprolide acetate 3.75 mg administered to patients with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy.

A total of 120 male patients will receive a single, i.m. injection of leuprolide acetate 3.75 mg initially on study day 0 (after baseline assessment) and then monthly (i.e. every 28 days) for five months.

12 of the patients will also have plasma leuprolide levels measured for PK analysis during the first 3 injection periods (PK group). These patients will belong to pre-defined study sites.

Conditions
Prostate Cancer
Being tested
leuprolide acetate
Keywords
Phase III, open label, multiple dose, safety study, pharmacokinetic study, efficacy study
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • leuprolide acetateDrug

What is being measured

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

  1. Efficacy: to determine the proportion of patients achieving castration levels of plasma testosterone (defined as <0.5 ng/mL) 4 weeks after the first administration

  2. to determine the proportion of patients maintaining castration levels of plasma testosterone from week 4 to study end

  3. to determine the proportion of patients showing acute rises in plasma testosterone levels upon repeated dosing from week 4 to study end

  4. Safety: evaluation of the safety of the new formulation based on adverse events (AEs), local tolerability, vital signs, electrocardiograms (ECGs), and clinical parameters

Secondary outcomes (2)

  1. Efficacy: determination of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prostate-specific antigen (PSA) concentrations

  2. World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status, bone pain, urinary symptoms and urinary pain after administration

Timeline

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

  1. First posted10 Aug 2005 (estimated)
  2. Study startSep 2005
  3. Study completionNov 2007

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00128531
Sponsor's protocol ID
CRO-04-62
Status last verified
Nov 2007
First submitted
8 Aug 2005
Last updated
14 Nov 2007
Results posted
No

Publications

  • Marberger M, Kaisary AV, Shore ND, Karlin GS, Savulsky C, Mis R, Leuratti C, Germa JR. Effectiveness, pharmacokinetics, and safety of a new sustained-release leuprolide acetate 3.75-mg depot formulation for testosterone suppression in patients with prostate cancer: a Phase III, open-label, international multicenter study. Clin Ther. 2010 Apr;32(4):744-57. doi: 10.1016/j.clinthera.2010.04.013.

    PubMed 20435244

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing leuprolide acetate in people with Prostate Cancer, run by GP-Pharm at 28 sites in 9 countries.

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 30 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: finished, as of the sponsor's last update on 14 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Czechia, Hungary, Italy, Austria and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Efficacy: to determine the proportion of patients achieving castration levels of plasma testosterone (defined as <0.5 ng/mL) 4 weeks after the first administration. The study lists 4 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 NCT00128531, which also lists 1 linked publication.

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 14 Nov 2007.

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