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Prostate CancerPhase 3NCT00630799

Efficacy and Safety Study of a New Leuprolide Acetate 17 mg Depot to Treat Prostate Cancer Patients

A Phase 3 study testing leuprolide acetate in people with Prostate Cancer, run by GP-Pharm at 8 sites in United States.

Terminated

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

Official record
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Trial summary

This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot, administered three months apart, in subjects with prostate cancer who might benefit from medical androgen deprivation therapy 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
8 sitesUnited States
Study dates
May 2008to Jul 2009
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 prostate, who might benefit from medical androgen deprivation therapy;
  • life expectancy of at least 1 year;
  • WHO/ECOG performance status of 0, 1, or 2;
  • adequate renal function at screening as defined by serum creatinine <= 1.6 times the upper limit of normal (ULN) 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;
  • presence of any tumor in the immediate vicinity which could cause cord compression, in the opinion of the Investigator, taking into account medical history and clinical observations;
  • 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;
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  • 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;
  • previous hormonal therapy for treatment of prostate cancer, such as LHRH analogues (e.g. Lupron®, Zoladex®, etc.) (no wash-out allowed);
  • previous treatment with AR-receptor 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 prior to or after baseline;
  • previous local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeks prior to or after baseline;
  • any investigational drug within 5 half-lives of its physiological action or 3 months, whichever is longer, before baseline;
  • administration of 5-α-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®, 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;
  • uncontrolled diabetes (patients with uncontrolled diabetes need to compensate the metabolic disorder before treatment with LH-RH analogues);
  • 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 on anticoagulative therapy including warfarin (Coumadin®) and heparin. Those patients on low dose low molecular weight heparin may be enrolled in the study;
  • Abnormal coagulation studies (PT/PTT) at baseline.
  • blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients (see exclusion 10);
  • 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 1 week of baseline or 1 week prior to and after study drug administration);
  • 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

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Center for Urologic Care

    Bryn Mawr, Pennsylvania, 19010

  • Lawrenceville Urology

    Lawrenceville, New Jersey, 08648

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates

    Nashville, Tennessee, 37209

  • Advanced Research Institute

    New Port Richey, Florida, 34655

  • Hudson Valley Urology

    Poughkeepsie, New York, 12601

  • Urology San Antonio Research, PA

    San Antonio, Texas, 78229

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Efficacy and Safety of a New Leuprolide Acetate 17 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients

This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot, administered three months apart, in subjects with prostate cancer who might benefit from medical androgen deprivation therapy

Conditions
Prostate Cancer
Being tested
leuprolide acetate
Keywords
prostate, cancer
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

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

  • leuprolide acetateDrug

    17 mg i.m.

Study groups in NCT00630799
Study groupRoleWhat they receive
1Experimentalleuprolide acetate administered by i.m. injection as two doses of 17 mg each during a period of 6 months (one dose every 3 months)
Receives: Drug: leuprolide acetate

What is being measured

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

  1. Percent of successful patients achieving chemical castration

    Measured: Days 28, 84, and 168

Secondary outcomes (10)

  1. WHO/ECOG performance status

    Measured: Days 14, 28, 56, 84, 112, and 168

  2. Serum LH concentration (mIU/mL)

    Measured: Days 2, 14, 28, 56, 84, 86, 112, and 168

  3. Serum FSH concentration (mIU/mL)

    Measured: Days 2, 14, 28, 56, 84, 86, 112, and 168

  4. Serum PSA concentration (ng/mL)

    Measured: Days 2, 14, 28, 56, 84, 86, 112, and 168

  5. Frequency of bone pain

    Measured: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168

  6. plasma testosterone concentration (ng/mL) in PK population

    Measured: week 4 and week 12

  7. Occurrence of hot flushes

    Measured: Days 0, 2, 14, 28, 56, 84, 86, 112, and 168

  8. Plasma leuprolide concentrations (pg/mL) in PK population

    Measured: Days 2, 14, 28, 56, 84, 86, 112, and 168

  9. Frequency of urinary symptoms

    Measured: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168

  10. Frequency of urinary pain

    Measured: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168

Timeline

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

  1. First posted7 Mar 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionApr 2009
  4. Study completionJul 2009

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
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00630799
Sponsor's protocol ID
GP/C/04/PRO
Status last verified
Sep 2010
First submitted
27 Feb 2008
Last updated
9 Sep 2010
Results posted
No
Data monitoring committee
No

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 8 sites in United States.

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 32 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 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 was stopped early. 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?

Percent of successful patients achieving chemical castration (time frame: Days 28, 84, and 168). 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 NCT00630799.

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 Sep 2010.

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