Trial · Interventional

CompletedPhase 3Results postedRegistry data

Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

NCTNCT00801242Other idFE200486 CS29Other id2008-003931-19Other id2008

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 220 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 6 countries
Belgium, France, Germany, Italy, Netherlands, Spain
Start: Dec 2008
Primary completion: Jun 2012
Completion: Jul 2013
First posted: 3 Dec 2008 (estimated)
Last update posted: 3 Sept 2014 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008200920102011201220132014

Ph 3
Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer
NCT00801242
Dec 2008 to Jul 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Degarelix 240 mg / 80 mgDrug

Arms1

Experimental
Degarelix 240 mg / 80 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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.

Secondary outcomes(7)

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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Up to 24 months after end of induction period

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

Group	Value (days)
Degarelix 240 mg / 80 mg	392

Secondary and other outcome results(7)

Secondary outcomeMean· 7 months

Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD

Group	Value (percentage of baseline)	Spread
Degarelix 240 mg / 80 mg	-90.8	16.6

Secondary outcomeMedian· Up to 24 months after end of induction period

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

Group	Value (days)
Degarelix 240 mg / 80 mg	112

Secondary outcomeNumber· 7 months

Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD

Group	Value (participants)
Degarelix 240 mg / 80 mg	210

Secondary outcomeMean· Up to 31 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

Group	Value (units on a scale)	Spread
Degarelix 240 mg / 80 mg	24.5	18.0

Secondary outcomeMean· Up to 31 months

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

Group	Value (units on a scale)	Spread
Degarelix 240 mg / 80 mg	3.1	5

Secondary outcomeNumber· Up to 3 x 31 months

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment

Group	Value (participants)
Degarelix 240 mg / 80 mg	4

Secondary outcomeNumber· Up to 3 x 31 months

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment

Group	Value (participants)
Degarelix 240 mg / 80 mg	2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Degarelix 240 mg / 80 mgDegarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.	–	51 / 216	185 / 216

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

Indexing hint: Clinical trial · 2017

Factors Predicting the Off-treatment Duration in Patients with Prostate Cancer Receiving Degarelix as Intermittent Androgen Deprivation Therapy.

Abrahamsson et al. 2017European urology focuscited by 3

PMID 28753747DOI 10.1016/j.euf.2015.12.008PUB-28753747

Full text at the publisher

Publisher page

Indexing hint: Clinical trial · 2014

Degarelix as an intermittent androgen deprivation therapy for one or more treatment cycles in patients with prostate cancer.

Boccon-Gibod et al. 2014European urologycited by 15

PMID 24954791DOI 10.1016/j.eururo.2014.05.037PUB-24954791

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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. 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

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