Prostate CancerPhase 2NCT00818623

Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 30 sites in 7 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 trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. 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: 172 participants
Where: 30 sitesin 7 countries
Study dates: Nov 2002to Oct 2004
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

Written informed consent obtained before any trial related procedures
Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months

Who cannot join

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers

Show all 12Show fewer

Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial

Trial locations and contacts

30 sites in 7 countries.

Country

City, postcode or hospital

30 sites in 7 countries

Finland6 sites

Marian Sairaala
Helsinki
P-K Keskussairaala
Joensuu
Vuorikadun lääkäriasema
Kuopio
OYS
Oulu
Kirugikeskus
Seinäjoki
TAYS
Tampere

Other trials in Finland

Hungary6 sites

Bajcsy-Zsilinszky Hospital, Urology
Budapest
Jahn Ferenc Dél Pesti Hospital, Urology
Budapest
Péterfy Hospital, Urology
Budapest
Bács-Kiskun County Hospital, Urology
Kecskemét
Hospital of Local Gov. Szeged, Urology
Szeged
MÁV Hospital, Urology
Szolnok

Other trials in Hungary

Russia5 sites

City Hospital #1, State Med Univ/Urology
Moscow
Institute of Urology of MoH
Moscow
Moscow City Hospital #60, Urology
Moscow
City Hospital #15, Urology Department
Saint Petersburg
City Hospital #26, Urology Department
Saint Petersburg

Other trials in Russia

Sweden5 sites

Sahlgrenska Universitetssjukehuset
Gothenburg
Helsingborgs Lasaret
Helsingborg
Universitetssjukehuset, MAS
Malmö
University Hospital, Örebro
Örebro
Akademiska Sjukhuset Uppsala
Uppsala

Other trials in Sweden

Romania4 sites

CF2 Hospital - Bucharest, Urology
Bucharest
Dr. Th Burghele Hospital
Bucharest
Fundeni Hospital - Bucharest, Urology
Bucharest
County Hospital - Timisoara, Urology
Timișoara

Other trials in Romania

Denmark3 sites

Rigshospitalet
Copenhagen
KAS Glostrup
Glostrup Municipality
KAS Herlev
Herlev

Other trials in Denmark

Norway1 site

Sentralsykehuset i Rogland
Stavanger

Other trials in Norway

About this study

Official title: An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients

Read the detailed description

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Conditions: Prostate Cancer
Being tested: Degarelix
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
Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
DegarelixDrug
Also called FE200486
Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
DegarelixDrug
Also called FE200486
Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
DegarelixDrug
Also called FE200486
Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
DegarelixDrug
Also called FE200486
Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
DegarelixDrug
Also called FE200486
Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
DegarelixDrug
Also called FE200486
Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
DegarelixDrug
Also called FE200486
Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection

Study groups in NCT00818623
Study group	Role	What they receive
Degarelix 120 mg (20 mg/mL)	Experimental	Degarelix 120 mg (20 mg/mL) Receives: Drug: Degarelix
Degarelix 120 mg (40 mg/mL)	Experimental	Degarelix 120 mg (40 mg/mL) Receives: Drug: Degarelix
Degarelix 160 mg (40 mg/mL)	Experimental	Degarelix 160 mg (40 mg/mL) Receives: Drug: Degarelix
Degarelix 200 mg (40 mg/mL)	Experimental	Degarelix 200 mg (40 mg/mL) Receives: Drug: Degarelix
Degarelix 200 mg (60 mg/mL)	Experimental	Degarelix 200 mg (60 mg/mL) Receives: Drug: Degarelix
Degarelix 240 mg (40 mg/mL)	Experimental	Degarelix 240 mg (40 mg/mL) Receives: Drug: Degarelix
Degarelix 240 mg (60 mg/mL)	Experimental	Degarelix 240 mg (60 mg/mL) Receives: Drug: Degarelix
Degarelix 320 mg (60 mg/mL)	Experimental	Degarelix 320 mg (60 mg/mL) Receives: Drug: Degarelix

What is being measured

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

Time From Dosing Until Testosterone Levels >0.5 ng/mL
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.
Measured: 3 months

Secondary outcomes (7)

Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.
Measured: Two - six months
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.
Measured: 3 months
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.
Measured: 3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
Measured: 3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
Measured: 3 months
Evaluation of Liver Function Tests
The figures presents 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: 3 months
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes 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 participants in each group with normal baseline and markedly abnormal value post-baseline.
Measured: 3 months

Timeline

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

Nov 2002Oct 2004

First posted8 Jan 2009 (estimated)
Study startNov 2002
Primary completionOct 2004
Study completionOct 2004

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: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00818623
Sponsor's protocol ID: FE200486 CS07
Status last verified: May 2011
First submitted: 7 Jan 2009
Last updated: 30 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients
ClinicalTrials.gov ID: NCT00818623
Acronym / sponsor ID: FE200486 CS07
Conditions: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2002
Primary completion: Oct 2004 (actual)
Study completion: Oct 2004 (actual)
First posted: 8 Jan 2009 (estimated)
Results: Posted 31 Mar 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Degarelix 120 mg (20 mg/mL)	Experimental	Drug: DegarelixDegarelix 120 mg (20 mg/mL)
Degarelix 120 mg (40 mg/mL)	Experimental	Drug: DegarelixDegarelix 120 mg (40 mg/mL)
Degarelix 160 mg (40 mg/mL)	Experimental	Drug: DegarelixDegarelix 160 mg (40 mg/mL)
Degarelix 200 mg (40 mg/mL)	Experimental	Drug: DegarelixDegarelix 200 mg (40 mg/mL)
Degarelix 200 mg (60 mg/mL)	Experimental	Drug: DegarelixDegarelix 200 mg (60 mg/mL)
Degarelix 240 mg (40 mg/mL)	Experimental	Drug: DegarelixDegarelix 240 mg (40 mg/mL)
Degarelix 240 mg (60 mg/mL)	Experimental	Drug: DegarelixDegarelix 240 mg (60 mg/mL)
Degarelix 320 mg (60 mg/mL)	Experimental	Drug: DegarelixDegarelix 320 mg (60 mg/mL)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Written informed consent obtained before any trial related procedures
Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml

Key exclusion criteria (12 listed)

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486

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: FE200486Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection	Drug	Degarelix 120 mg (20 mg/mL)
DegarelixAlso: FE200486Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection	Drug	Degarelix 120 mg (40 mg/mL)
DegarelixAlso: FE200486Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection	Drug	Degarelix 160 mg (40 mg/mL)
DegarelixAlso: FE200486Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection	Drug	Degarelix 200 mg (40 mg/mL)
DegarelixAlso: FE200486Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection	Drug	Degarelix 200 mg (60 mg/mL)
DegarelixAlso: FE200486Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection	Drug	Degarelix 240 mg (40 mg/mL)
DegarelixAlso: FE200486Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection	Drug	Degarelix 240 mg (60 mg/mL)
DegarelixAlso: FE200486Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection	Drug	Degarelix 320 mg (60 mg/mL)

Primary outcome

Time From Dosing Until Testosterone Levels >0.5 ng/mL
Time frame: 3 months
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.

7 secondary outcomes

Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
Time frame: Two - six months
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
Time frame: 3 months
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
Time frame: 3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
Time frame: 3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
Time frame: 3 months
Evaluation of Liver Function Tests
Time frame: 3 months
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Time frame: 3 months

Results and safety

Results posted to the registry on 31 Mar 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Degarelix 120mg (20mg/mL)	26	24
Degarelix 120mg (40mg/mL)	12	8
Degarelix 160mg (40mg/mL)	13	9
Degarelix 200mg (40mg/mL)	24	19
Degarelix 200mg (60mg/mL)	27	23
Degarelix 240mg (40mg/mL)	24	21
Degarelix 240mg (60mg/mL)	27	23
Degarelix 320mg (60mg/mL)	27	26

Primary outcome: Time From Dosing Until Testosterone Levels >0.5 ng/mL

Time frame: 3 months. Median (95% Confidence Interval). Unit: days

Measure	Degarelix 120mg (20mg/mL) n = 25	Degarelix 120mg (40mg/mL) n = 12	Degarelix 160mg (40mg/mL) n = 12	Degarelix 200mg (40mg/mL) n = 24	Degarelix 200mg (60mg/mL) n = 24	Degarelix 240mg (40mg/mL) n = 24	Degarelix 240mg (60mg/mL) n = 24	Degarelix 320mg (60mg/mL) n = 24
Value	84 (63 to 119)	63 (28 to 133)	70 (28 to 98)	140 (112 to 147)	84 (35 to 112)	140 (112 to 182)	87.5 (28 to 140)	133 (91 to 154)

Degarelix 120mg (20mg/mL) vs Degarelix 120mg (40mg/mL) vs Degarelix 160mg (40mg/mL) vs Degarelix 200mg (40mg/mL) vs Degarelix 200mg (60mg/mL) vs Degarelix 240mg (40mg/mL) vs Degarelix 240mg (60mg/mL) vs Degarelix 320mg (60mg/mL): p = 0.0000586, Log Rank

Population analysed: ITT population.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Degarelix 120mg (20mg/mL)	2 of ?	14 of ?	Not reported
Degarelix 120mg (40mg/mL)	2 of ?	10 of ?	Not reported
Degarelix 160mg (40mg/mL)	1 of ?	7 of ?	Not reported
Degarelix 200mg (40mg/mL)	2 of ?	20 of ?	Not reported
Degarelix 200mg (60mg/mL)	1 of ?	14 of ?	Not reported
Degarelix 240mg (40mg/mL)	4 of ?	22 of ?	Not reported
Degarelix 240mg (60mg/mL)	3 of ?	10 of ?	Not reported
Degarelix 320mg (60mg/mL)	4 of ?	19 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

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Enrolling by invitationObservational study
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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

30 sites in 7 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 30 sites in 7 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 6 inclusion and 12 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Finland, Hungary, Russia, Sweden, Romania and 2 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 31 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?

Time From Dosing Until Testosterone Levels >0.5 ng/mL (time frame: 3 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 NCT00818623.

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 30 Nov 2023.