Prostate CancerPhase 3NCT00295750
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
A Phase 3 study testing Degarelix and Leuprolide 7.5 mg in people with Prostate Cancer, run by Ferring Pharmaceuticals at 35 sites in 12 countries.
Trial summary
The study was a three-arm, active-control, multi-centre, parallel group study. 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 and Leuprolide 7.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 35 sitesin 12 countries
- Study dates
- Feb 2006to Oct 2007
- Phase
- Phase 3
- 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
Main Inclusion Criteria:
- Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Baseline testosterone >1.5 ng/mL.
- Life expectancy of at least 12 months.
Trial locations and contacts
35 sites in 12 countries.
35 sites in 12 countries
United States23 sites
Advanced Urology Medical Center
Anaheim, California, 92801
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508
South Florida Medical Research
Aventura, Florida, 33180
Pacific Clinical Center
Beverly Hills, California, 90210
Jay A. Motola, MD, FACS
Carmel, New York, 10512
Northeast Urology Research
Concord, North Carolina, 28025
Urology Associate PC
Denver, Colorado, 80210
University of Colorado
Denver, Colorado, 80262
Simi-San Faernando Valley Urology Associates
Granada Hills, California, 91344
The Urology Center
Greensboro, North Carolina, 27401
Urology Centers of Alabama
Homewood, Alabama, 35209
South Orange County Medical Research Center
Laguna Woods, California, 92653
Lawrenceville Urology
Lawrenceville, New Jersey, 08648
Grand Strand Urology
Myrtle Beach, South Carolina, 29572
Urology of Virginia Research
Norfolk, Virginia, 23502
Florida Foundation for Healthcare Research
Ocala, Florida, 34474
Univeristy Urological Research Institute
Providence, Rhode Island, 02904
University Urological Research Institute
Providence, Rhode Island, 02904
Urology San Antonio Research
San Antonio, Texas, 78229
Office of Jeffrey Frankel
Seattle, Washington, 98166
Regional Urology
Shreveport, Louisiana, 71106
State College Urologic Association
State College, Pennsylvania, 16801
Western Clinical Research
Torrance, California, 90505
Puerto Rico2 sites
Cristo Redentor Hospital
La Hacienda, 00784
San Juan VA Medical Center
San Juan, 00921
Canada1 site
Bruce W. Palmer Urology Inc, 125-70 Exhibition Street
Kentville, Nova Scotia, B4N 4KB
Czechia1 site
Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III
Jindřichův Hradec, 37738
Germany1 site
Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3
Mannheim, 68167
Hungary1 site
Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57
Szeged, H-6725
Mexico1 site
Hospital General "Dr Santiago Ramon y Cajal", ISSSTE
Predio Canoas S/N, Durango, DGO, 34079
Ukraine1 site
Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.
Kiev, 2125
United Kingdom1 site
Derriford Hospital, Derriford Road
Plymouth, PL6 8DH
About this study
Official title: An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
The study was a three-arm, active-control, multi-centre, parallel group study.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix, Leuprolide 7.5 mg
- Keywords
- 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.
DegarelixDrug
Also called FE200486
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
DegarelixDrug
Also called FE 200486
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
Leuprolide 7.5 mgDrug
Also called Lupron
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
| Study group | Role | What they receive |
|---|---|---|
| degarelix 240/160 mg | Experimental | Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days. Receives: Drug: Degarelix |
| degarelix 240/80 mg | Experimental | Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days. Receives: Drug: Degarelix |
| Leuprolide 7.5 mg | Active comparator | Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0. Receives: Drug: Leuprolide 7.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
Measured: 12 months
Secondary outcomes (8)
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).
Measured: 2 weeks
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
Measured: 3 days
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252.
Measured: Day 252, Day 255, and Day 259
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.
Measured: Days 14 and 28
Participants Grouped by Time to Prostate-specific Antigen Failure
The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.
Measured: 12 months
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.
Measured: Baseline to Day 364
The Mean Value of QTc Interval as Measured by Electrocardiogram
The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.
Measured: 12 months
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295750
- Sponsor's protocol ID
- FE200486 CS21
- Status last verified
- Dec 2012
- First submitted
- 22 Feb 2006
- Last updated
- 19 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
PubMed 19035858Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
PubMed 34350976
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
- ClinicalTrials.gov ID
- NCT00295750
- Acronym / sponsor ID
- FE200486 CS21
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 24 Feb 2006 (estimated)
- Results
- Posted 16 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was a three-arm, active-control, multi-centre, parallel group study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| degarelix 240/160 mg | Experimental | Drug: DegarelixInitial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days. |
| degarelix 240/80 mg | Experimental | Drug: DegarelixInitial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days. |
| Leuprolide 7.5 mg | Active comparator | Drug: Leuprolide 7.5 mgLeuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DegarelixAlso: FE200486Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days. | Drug | degarelix 240/160 mg |
| DegarelixAlso: FE 200486Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days. | Drug | degarelix 240/80 mg |
| Leuprolide 7.5 mgAlso: LupronLeuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0. | Drug | Leuprolide 7.5 mg |
Primary outcome
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
Time frame: 12 months
Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
8 secondary outcomes
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
Time frame: 2 weeks
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
Time frame: 3 days
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
Time frame: Day 252, Day 255, and Day 259
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Time frame: Days 14 and 28
Participants Grouped by Time to Prostate-specific Antigen Failure
Time frame: 12 months
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Time frame: Baseline to Day 364
The Mean Value of QTc Interval as Measured by Electrocardiogram
Time frame: 12 months
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19035858Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
- Derived from this study: PubMed 34350976Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
35 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Degarelix and Leuprolide 7.5 mg in people with Prostate Cancer, run by Ferring Pharmaceuticals at 35 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2012. 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, Puerto Rico, Canada, Czechia, Germany and 7 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?
Yes. Results are posted in the registry (first posted 16 Apr 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?
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 (time frame: 12 months). 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 NCT00295750, which also lists 2 linked publications.
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 2012.