Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004077

Trial Description

start of 1:1-Block title

Title

An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this uncontrolled, multi-center, open-label trial was to investigate the
feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the
treatment of prostate cancer.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The participants received one or more treatment cycles of seven monthly degarelix doses
during the induction period(s). The off-treatment period(s) started when prostate-specific
antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels. A visit was scheduled
on a monthly basis during the induction treatment periods, and every two months during the
off-treatment periods. During the off-treatment periods, degarelix treatment was
re-initiated when PSA >4 ng/mL. The maximum of degarelix IAD treatment cycles that a
participant could receive was limited to three.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004077
  •   2012/08/03
  •   2008/12/02
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2008-003931-19 
  •   NCT00801242  (ClinicalTrials.gov)
  •   FE200486 CS29  (Ferring Pharmaceuticals)
  •   2008-003931-19 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Degarelix 240 mg / 80 mg
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment; time frame: Up to 24 months after end of induction period; Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD; time frame: 7 months
- Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment; time frame: Up to 24 months after end of induction period; Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.
- Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD; time frame: 7 months
- Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD; time frame: Up to 31 months; The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
- Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD; time frame: Up to 31 months; The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment; time frame: Up to 3 x 31 months; 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 during the trial.
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment; time frame: Up to 3 x 31 months; This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Belgium
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Spain
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2008/12/31
  •   200
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Has given written informed consent before any trial-related activity is performed. A
trial-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), and is in need of androgen deprivation treatment.

- Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level
(measured at a central laboratory) must be >4 ng/mL and ≤50 ng/mL.

- Patients with Localised Prostate Cancer or Patients with Previous Therapy with
Curative Intention and a Rising PSA - PSA doubling time (based on patient records at
the trial site) must be <24 months. There is no minimum PSA level required and the
maximum PSA must be ≤50 ng/mL.

- Is a male patient aged 18 years or older.

- Has an Eastern Cooperative Oncology Group score of ≤2.

- Has a life expectancy of at least 24 months.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Has had previous or is currently under hormonal management of prostate cancer
(surgical castration or other hormonal manipulation, including gonadotropin releasing
hormone (GnRH) receptor agonists, GnRH antagonists, anti-androgens, 5-alpha reductase
inhibitors and estrogens). However, for patients having undergone prostatectomy or
radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for
a maximum duration of 6 months is accepted. This treatment should have been
terminated at least 6 months prior to Screening Visit.

- Is considered to be candidate for curative therapy, i.e. radical prostatectomy or
radiotherapy.

- Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe
urticaria and/or angioedema.

- Has hypersensitivity towards any component of the investigational medicinal product.

- Has had cancer within the last five years except prostate cancer and surgically
removed basal or squamous cell carcinoma of the skin.

- Has a known or suspected clinically significant liver and/or biliary disease.

- Has a history of or risk factors for Torsades de Pointes

- At time of inclusion receives concomitant medications that might prolong the QT
interval.

- Has any clinically significant laboratory abnormalities which in the judgment of the
investigator would affect the patient's health or the outcome of the trial.

- Has a clinically significant disorder (other than prostate cancer) including but not
limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological,
or psychiatric disease, and alcohol or drug abuse or any other condition, which may
affect the patient's health or the outcome of the trial as judged by the
investigator.

- Has severe kidney failure (creatinine clearance <30 mL/min), based on the serum
creatinine value at Screening Visit and calculated by Cockcroft-Gault algorithm (only
valid in France).

- Has a mental incapacity or language barriers precluding adequate understanding or co
operation.

- Has received an investigational drug within the last 28 days preceding Screening
Visit or longer if considered to possibly influence the outcome of the current trial.

- Has previously participated in any degarelix trial

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Ferring Pharmaceuticals
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Ferring Pharmaceuticals
    • Clinical Development Support 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Ferring Pharmaceuticals
    • Clinical Development Support 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/07/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.