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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012786-58 | EudraCT Number |
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The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin (Decapeptyl®) 22.5 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin (Decapeptyl®) | Drug | One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA | PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
| At month 6 post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
| At month 1 and 3 post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Erasme | Brussels | 1070 | Belgium | |||
| UZ Brussels |
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Study Initiation Date: 30-Nov-2009. Subjects screened were 339 and screen failures were 13.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triptorelin (Decapeptyl®) 22.5 mg | Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-assignment |
|
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| TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000 A TMPRSS2-ERG score <35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.' | At baseline, month 1, 3 and 6 post-treatment |
| Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) | At month 1, 3 and 6 post-treatment |
| PSA Level | At baseline, month 1, 3 and 6 post-treatment |
| Safety, Assessed Through the Collection of Adverse Events (AEs) | For the duration of the study (up to month 6) |
| Brussels |
| 1090 |
| Belgium |
| UCL Saint-Luc | Brussels | 1200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| Fredericia Sygehus | Fredericia | Denmark |
| Frederiksbergs Hospital | Frederiksberg | 2000 | Denmark |
| Herlev University Hospital | Herlev | 2730 | Denmark |
| Odense Universitets hospital | Odense | 5000 | Denmark |
| Clinique Rhône Durance | Avignon | 84000 | France |
| Hôpital Pellegrin | Bordeaux | 33076 | France |
| CHU Henri Mondor | Créteil | 94010 | France |
| CHU Michalon | Grenoble | 38043 | France |
| Chru Lille | Lille | 59037 | France |
| Hôpital Nord | Marseille | 13915 | France |
| Clinique Beau Soleil | Montpellier | 34000 | France |
| Private practice | Nancy | 54100 | France |
| CHU Nantes | Nantes | 44093 | France |
| CHU Pasteur | Nice | 06002 | France |
| Hôpital Val de Grâce | Paris | 75005 | France |
| Institut Mutualiste Monsouris | Paris | 75014 | France |
| Hôpital Henry Gabrielle | Saint-Genis-Laval | 69230 | France |
| Hôpital Foch | Suresnes | 92150 | France |
| CHU Toulouse | Toulouse | 31059 | France |
| IRCCS Fondazione S. Raffaele del Monte Tabor | Milan | 20132 | Italy |
| AOU San Luigi Gonzaga | Torino | 10043 | Italy |
| P.Stradins Clinical University Hospital | Riga | LV 1002 | Latvia |
| Center of Oncology | Riga | LV1079 | Latvia |
| Medical University Clinics | Kaunas | LT-50009 | Lithuania |
| University Hospital | Klaipėda | Lithuania |
| University Oncological Institute | Vilnius | LT-08660 | Lithuania |
| Ziekenhuis Amstelland | Amstelveen | Netherlands |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Diaconessenhuis | Leiden | 2333ZA | Netherlands |
| Antonius Ziekenhuis | Sneek | Netherlands |
| Medical Center | Arad | Romania |
| Oncology Institute | Bucharest | 72435 | Romania |
| Sc E-Uro Srl | Cluj-Napoca | Romania |
| Oncomed | Timișoara | Romania |
| Hospital Juan Canalejo | A Coruña | 15006 | Spain |
| Hospital Valle Hebrón | Barcelona | 08035 | Spain |
| Hospital Clinic | Barcelona | 08036 | Spain |
| Hospital de Basurto | Bilbao | 48013 | Spain |
| Hospital General Universitario | Madrid | 28007 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Infanta Sofía | Madrid | 28702 | Spain |
| Instituto de Oncología | Valencia | 46009 | Spain |
| Bristol Royal Infirmary | Bristol | United Kingdom |
| Addenbrookes Hospital | Cambridge | CB2 8RP | United Kingdom |
| University Hospital Wales | Cardiff | CF14 4XW | United Kingdom |
| University Hospital Coventry | Coventry | CV3 / CV2 2DX | United Kingdom |
| Derby City Hosptial | Derby | DE22 3NE | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | EX2 5DW | United Kingdom |
| Falkirk & District Royal Infirmary | Falkirk | FK1 5QE | United Kingdom |
| Leicester General Hospital | Leicester | LE5 4PW | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Lister Hospital | Stevenage | SG1 4AB | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Triptorelin (Decapeptyl®) 22.5 mg | Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | Cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | KG |
| ||||||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m² |
| ||||||||||||||||||||||
| PCA-3 Score | PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
| Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA | PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
| Number of participants analyzed were 298 as one participant was admitted to an asylum and was withdrawn before month 1 visit was scheduled. No post-baseline assessment was available for this patient. | Posted | Number | participants | At month 6 post-treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | PCA-3 score = (mRNA PCA3/mRNA PSA)x1000
| Analysis based on number (N) of patients with a valid value. Intention-to-treat (ITT) population. | Posted | Number | participants | At month 1 and 3 post-treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000 A TMPRSS2-ERG score <35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.' | Analysis based on number (N) of patients with a valid value. ITT population. | Posted | Number | participants | At baseline, month 1, 3 and 6 post-treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) | Analysis based on number (N) of patients with a valid value. ITT population. | Posted | Number | percentage of participants | At month 1, 3 and 6 post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | PSA Level | Analysis based on number (N) of patients with a valid value. ITT population. | Posted | Median | Full Range | μg/L | At baseline, month 1, 3 and 6 post-treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Safety, Assessed Through the Collection of Adverse Events (AEs) | Posted | Number | participants | For the duration of the study (up to month 6) |
|
|
|
Up to month 6
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Triptorelin (Decapeptyl®) 22.5 mg | Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed. | 37 | 325 | 89 | 325 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chronic heart failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Perforated colon | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Perforated gall bladder | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fecal peritonitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Liver failure | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Septicaemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Suicide | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Worsening of chronic lumbago | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Severe anemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cancer progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Bone pain due to metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Rectum tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Entero-cutaneous fistula | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Septic venous thrombophlebitis | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Septicemia due to catheter | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urothelial tumor in the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Claudication | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Acute pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Appendicitis acute | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urethral stricture | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Blocked nephrostomy catheter | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Allergy to conc med | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Right pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Right central pulmonary tumor malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bilateral pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardio respiratory arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Larynx adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia pneumocystis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Thoracic pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Unspecific thoracic pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hemorrhage prostate | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Right inguinal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Deliberate medication overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| End stage renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Heamaturia | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Increased pain in right thigh | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Oncology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
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| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| <35 |
|
| ≥35 |
|
| Missing - No sample analysis done |
|
| Title | Measurements |
|---|
|
| ≥35 |
|
| Missing - No sample analysis done |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Month 1 (N=322) |
| |||||
| Month 3 (N=313) |
| |||||
| Month 6 (N=298) |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Baseline (N=321) |
| |||||
| Month 1 (N=320) |
| |||||
| Month 3 (N=311) |
| |||||
| Month 6 (N=296) |
|
| Any Adverse Events (AEs) |
| |||||
| Any Treatment Emergent Adverse Events (TEAEs) |
| |||||
| TEAEs Leading to Withdrawal |
| |||||
| TEAEs Leading to Death |
| |||||
| Serious Adverse Events (SAEs) |
|