Prostate CancerPhase 2NCT00116753
A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 56 sites in 11 countries.
Trial summary
The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix. 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
- 460 participants
- Where
- 56 sitesin 11 countries
- Study dates
- Jan 2005to Nov 2006
- 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
- Has given written consent before 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.
- Has a histologically confirmed (Gleason graded) 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 undergone prostatectomy or radiotherapy with curative intention.
- Is a male patient aged 18 years or over.
- Has a baseline serum testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
- Has an ECOG (Eastern Cooperative Oncology Group) score of 2.
- Has a PSA value of 2 ng/mL.
- Has a life expectancy of at least 13 months.
Who cannot join
- Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit.
- Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit.
- Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema.
- Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- Has a known or suspected hepatic or symptomatic biliary disease.
- Has elevated serum ALT level above upper level of normal range or serum total bilirubin level above upper level of normal range as measured by the laboratory at the Screening Visit.
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- Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient's participation 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 study 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 28 days preceding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study.
- Has previously participated in any degarelix study.
Trial locations and contacts
56 sites in 11 countries.
56 sites in 11 countries
United States23 sites
Advanced Urology Medical Center
Anaheim, California, 92801
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508
Urology Research Option
Aurora, Colorado, 80012
South Florida Medical Research
Aventura, Florida, 33180
University of Missouri, Urology, Deptof Surgery
Columbia, Missouri, 65212
Northeast Urology Research
Concord, North Carolina, 28025
RT Services, Inc
Fort Myers, Florida, 33901
SW Florida Urological Associates
Fort Myers, Florida, 33907
Urology Association of Northern Texas
Fort Worth, Texas, 76104
The Urology Center
Greensboro, North Carolina, 27401
Urology Centers of Alabama
Homewood, Alabama, 35209
Medical Affiliationed Research Center
Huntsville, Alabama, 35801
Mississippi Urology Clinic
Jackson, Mississippi, 39202
Kansas City Urology Care
Kansas City, Missouri, 64131
Center for Urological Research
La Mesa, California, 91942
South Orange County Medical Research Center
Laguna Woods, California, 92653
Grand Strand Urology
Myrtle Beach, South Carolina, 29572
Urology San Antonio Research
San Antonio, Texas, 78229
Seatle Urology Research Centre
Seattle, Washington, 98166
Regional Urology
Shreveport, Louisiana, 71106
State College Urologic Association
State College, Pennsylvania, 16801
West Coast Clinical Research
Tarzana, California, 91356
Western Clinical Research
Torrance, California, 90505
Canada8 sites
The Male/Female Health Centres and Research
Barrie, Ontario
Brantford Urology Research
Brantford, Ontario
Southern Interior Medical Research Corp
Kelowna, British Columbia
North Bay Hospital
North Bay, Ontario
The Male/Female Health Centres and Research
Oakville, Ontario
Andreou Researce
Surrey, British Columbia
The Male Health Center
Toronto, Ontario
Can-Med Clinical Research Inc.
Victoria, British Columbia
Russia5 sites
Andros Clinic
Saint Petersburg
City Hospital #15
Saint Petersburg
City Hospital #26
Saint Petersburg
Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
Saint Petersburg
Pavlov State Medical University, Urology Department
Saint Petersburg
Finland4 sites
Helsinki University Hospital, Maria Hospital, Dept Urology
Helsinki
Central Hospital, North Karelian, Dept. of Urology
Joensuu
Oulu University Hospital, Department of Surgery Division of Urology
Oys
Tampere University Hospital, Dept. of Urology
Tampere
United Kingdom4 sites
Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary
Falkirk
Mount Vernon Cancer Centre, Marie Curie Research Wing
Middlesex
Castle Hill Hospital, Dept. Urology
North Humberside
Level 7, Urology Research Unit, Derriford Hospital
Plymouth
Romania3 sites
Centrul Medical Privat
Arad
Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
Bucharest
University CF Hospital No.2, Urology Clinic
Bucharest
France2 sites
Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie
La Roche-sur-Yon
Fédération d'Urologie et Néphrologie
Nice
Germany2 sites
Gemeinschaftspraxis Dres Effert und Benedic
Aachen
Klinik fuer Urologie, Vivantes Klinikum Am Urban
Berlin
Netherlands2 sites
Academic Medical Center, Urology
Amsterdam
St. Elisabeth Hospital
Tilburg
Serbia and Montenegro2 sites
Clinical Center of Serbia Institute of Urology and Nephrology
Belgrade
Clinical Center Novi Sad, Clinic of Urology Hajduk
Novi Sad
About this study
Official title: An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.
- 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: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9
DegarelixDrug
Also called FE200486
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9
DegarelixDrug
Also called FE200486
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10
| Study group | Role | What they receive |
|---|---|---|
| Degarelix 240@40/240@40 (1,3,6,9) | Active comparator | 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9. Receives: Drug: Degarelix |
| Degarelix 240@40/240@60(1,3,6,9) | Active comparator | 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9. Receives: Drug: Degarelix |
| Degarelix 240@40/240@60(1,4,7,10) | Active comparator | 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10. Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study
Figure in the table give the number of participants with all testosterone values <=0.5 ng/mL from Day 28 to the end of the study.
Measured: From Day 28 to 12 or 13 months
Secondary outcomes (4)
Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study
Figures in the table give the number of participants with all testosterone values <=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.
Measured: From after Day 28 to 12 or 13 months
Number of Participants With Testosterone <=0.5 ng/mL at Day 28
Figures in the table give number of participants with testosterone <=0.5 ng/mL 28 days after the initial dose of trial medication.
Measured: 28 Days
Liver Function Tests
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
Measured: 12 or 13 months
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Measured: 12 or 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2006
- Study completionNov 2006
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116753
- Sponsor's protocol ID
- FE200486 CS15
- Status last verified
- Nov 2010
- First submitted
- 30 Jun 2005
- Last updated
- 10 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00116753
- Acronym / sponsor ID
- FE200486 CS15
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Androgen ablation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 1 Jul 2005 (estimated)
- Results
- Posted 10 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Degarelix 240@40/240@40 (1,3,6,9) | Active comparator | Drug: Degarelix240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9. |
| Degarelix 240@40/240@60(1,3,6,9) | Active comparator | Drug: Degarelix240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9. |
| Degarelix 240@40/240@60(1,4,7,10) | Active comparator | Drug: Degarelix240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has given written consent before 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.
- Has a histologically confirmed (Gleason graded) 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 undergone prostatectomy or radiotherapy with curative intention.
- Is a male patient aged 18 years or over.
- Has a baseline serum testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
- Has an ECOG (Eastern Cooperative Oncology Group) score of 2.
Key exclusion criteria (11 listed)
- Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit.
- Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit.
- Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema.
- Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- Has a known or suspected hepatic or symptomatic biliary disease.
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: FE200486Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9 | Drug | Degarelix 240@40/240@40 (1,3,6,9) |
| DegarelixAlso: FE200486Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9 | Drug | Degarelix 240@40/240@60(1,3,6,9) |
| DegarelixAlso: FE200486Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10 | Drug | Degarelix 240@40/240@60(1,4,7,10) |
Primary outcome
Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study
Time frame: From Day 28 to 12 or 13 months
Figure in the table give the number of participants with all testosterone values <=0.5 ng/mL from Day 28 to the end of the study.
4 secondary outcomes
Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study
Time frame: From after Day 28 to 12 or 13 months
Number of Participants With Testosterone <=0.5 ng/mL at Day 28
Time frame: 28 Days
Liver Function Tests
Time frame: 12 or 13 months
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline
Time frame: 12 or 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
56 sites in 11 countries: see every site and its status.
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 56 sites in 11 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 11 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 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Canada, Russia, Finland, United Kingdom and 6 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 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 10 Dec 2010). 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 Level <=0.5 ng/mL From Day 28 Until the End of the Study (time frame: From Day 28 to 12 or 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2010.