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Prostate CancerPhase 2NCT00116779

A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 35 sites in 2 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 the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone. 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?
Degarelix
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
35 sitesin 2 countries
Study dates
Feb 2004to Aug 2005
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Each patient must meet the following inclusion criteria before entry into the study.
  • Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
  • Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.
  • Male patient aged 18 years or over.
  • Has a baseline testosterone above the lower limit of normal range.
  • Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2.
  • Has a PSA value of greater than or equal to 2ng/mL.

Who cannot join

  • Any patient meeting one or more of the following exclusion criteria will not be entered into the study.
  • Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit.
  • Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function.
  • Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.
  • Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema.
  • Has hypersensitivity towards any component of the investigational products (degarelix or mannitol).
Show all 14Show fewer
  • Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
  • Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit.
  • Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study.
  • Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.
  • Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator.
  • Has a mental incapacity or language barriers precluding adequate understanding or cooperation.
  • Has received an investigational drug within the last 12 weeks preceding Screening Visit.
  • Has previously participated in any degarelix study

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States26 sites

  • Advanced Urology Medical Center

    Anaheim, California, 92801

  • Alaska Clinical Research Center, LLC

    Anchorage, Alaska, 99508

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Wyoming Research Foundation

    Cheyenne, Wyoming, 82001

  • Urology Associate PC

    Denver, Colorado, 80210

  • SW Florida Urological Associates

    Fort Myers, Florida, 33907

  • Northeast Indiana Research, LLC

    Fort Wayne, Indiana, 46825

  • The Urology Center

    Greensboro, North Carolina, 27401

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • South Orange County Medical Research Cnter

    Laguna Woods, California, 92653

  • Lawrenceville Urology

    Lawrenceville, New Jersey, 08648

  • RMD Clinical Reseach Institution LLC

    Melrose Park, Illinois, 60160

  • Florida Foundation for Healthcare Research

    Ocala, Florida, 34474

  • Hudson Valley Urology PC

    Poughkeepsie, New York, 12601

  • Univeristy Urological Research Institute

    Providence, Rhode Island, 02904

  • Nevada Urology Associates

    Reno, Nevada, 89511

  • Virginia Urology Center

    Richmond, Virginia, 23235

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • Pacific Clinical Research

    Santa Monica, California, 90404

  • Office of Jeffrey Frankel

    Seattle, Washington, 98166

  • Regional Urology

    Shreveport, Louisiana, 71106

  • University of Vermont, Dept of Surgery

    South Burlington, Vermont, 05403

  • State College Urologic Association

    State College, Pennsylvania, 16801

  • West Coast Clinical Research

    Tarzana, California, 91356

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Western Clinical Research

    Torrance, California, 90505

Other trials in United States

Canada9 sites

  • The Male and Female Health and Research Centers

    Barrie, Ontario, L4M7G1

  • Brantford Urology Research

    Brantford, Ontario, N3R4N3

  • Burlington Professional Care

    Burlington, Ontario, L7N3V2

  • Southern Interior Medical Research Corporation

    Kelowna, British Columbia, V1Y2H4

  • Valley Professional Center

    Kentville, Nova Scotia, B4N4K9

  • The Female/Male Health Centres

    Oakville, Ontario, L6H3P1

  • Dr. Cal Abdreau Research

    Surrey, British Columbia, V3V1N1

  • Can-Med Clinical Research, Inc.

    Victoria, British Columbia, V8T5G1

  • Dr. Gary Steinhoff Clinical Research

    Victoria, British Columbia, V8V3N1

Other trials in Canada

About this study

Official title: An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles

The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.

Conditions
Prostate Cancer
Being tested
Degarelix
Keywords
Prostate Cancer, Androgen ablation therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • DegarelixDrug

    Also called FE200486

    Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.

Study groups in NCT00116779
Study groupRoleWhat they receive
Degarelix 60mgExperimentalInitial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
Receives: Drug: Degarelix
Degarelix 80mgExperimentalInitial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Receives: Drug: Degarelix

What is being measured

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

  1. Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364

    Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364

    Measured: Day 28 to Day 364

  2. Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28

    Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.

    Measured: Day 28 - Day 364

Secondary outcomes (11)

  1. Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.

    Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.

    Measured: Day 3

  2. Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen

    Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.

    Measured: Day 0 (post dose) to Day 364

  3. Days to Prostate-Specific Antigen Progression

    Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.

    Measured: Day 0 (post dose) to Day 364

  4. Median Di-Hydrotestosterone Levels At Various Study Timepoints

    Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14

    Measured: Baseline, Days 1, 3, 7, 14

  5. Median Prostate-Specific Antigen Values at Various Study Timepoints

    Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.

    Measured: Baseline, Days 3, 14, 28, 84, 364

  6. Median Luteinizing Hormone Levels at Various Study Timeframes

    Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.

    Measured: Baseline, Days 1, 3, 7, 14

  7. Median Testosterone Levels at Various Days During the Study

    Testosterone levels at baseline and days 1, 3, 7, 14 and 364

    Measured: Baseline, Days 1,3,7,14,364

  8. Number of Participants With Abnormal Alanine Aminotransferase Values

    Participants whose alanine aminotransferase values were at levels above the normal range.

    Measured: Day 1 through day 364

  9. Number of Participants With Abnormal Aspartate Aminotransferase Values

    Participants with aspartate aminotransferase values that were above the normal range.

    Measured: Day 1 - 364

  10. Number of Participants With Abnormal Total Bilirubin Values

    Participants with abnormal total bilirubin values

    Measured: Day 1 - 364

  11. Participants With Markedly Abnormal Changes in Vital Signs or Body Weight

    Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.

    Measured: Day 364

Timeline

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

  1. First posted1 Jul 2005 (estimated)
  2. Study startFeb 2004
  3. Primary completionAug 2005
  4. Study completionAug 2005

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00116779
Sponsor's protocol ID
FE200486 CS14
Status last verified
Dec 2011
First submitted
30 Jun 2005
Last updated
19 Dec 2011
Data monitoring committee
Yes

Publications

  • Gittelman M, Pommerville PJ, Persson BE, Jensen JK, Olesen TK; Degarelix Study Group. A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America. J Urol. 2008 Nov;180(5):1986-92. doi: 10.1016/j.juro.2008.07.033. Epub 2008 Sep 17.

    PubMed 18801505

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 35 sites in 2 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 14 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364 (time frame: Day 28 to Day 364). The study lists 2 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 NCT00116779, 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 19 Dec 2011.

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