Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer

NCT01020448 | Completed Phase 3 Results

• 2 other identifiers: 8-79-52014-1682009-012786-58
• Study Type: interventional
• Target: 339
• Locations: 10 countries
• Sites: 59

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Locally advanced or metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 * Non-assessable = Associated PSA mRNA \<7500 copies/mL * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL * \<35 = PCA-3 mRNA above BLQ and less than 35 * ≥35 = PCA-3 mRNA greater or equal to 35

  At month 6 post-treatment

Secondary Outcomes (5)

• PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA

  At month 1 and 3 post-treatment

• TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)

  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)

Study Arms (1)

Triptorelin (Decapeptyl®) 22.5 mg

EXPERIMENTAL

Drug: Triptorelin (Decapeptyl®)

Interventions

Triptorelin (Decapeptyl®) DRUG

One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.

Triptorelin (Decapeptyl®) 22.5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment.
• An estimated survival time of at least twelve months according to the investigator's assessment.
• A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.

You may not qualify if:

• Previous surgical castration.
• Previous or has planned curative prostate cancer therapy (radiation/surgery)
• Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
• Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)

Sponsors & Collaborators

• Ipsen: lead

Study Sites (59)

Hôpital Erasme

Brussels, 1070, Belgium

Location

UZ Brussels

Brussels, 1090, Belgium

Location

UCL Saint-Luc

Brussels, 1200, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Fredericia Sygehus

Fredericia, Denmark

Location

Frederiksbergs Hospital

Frederiksberg, 2000, Denmark

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Odense Universitets hospital

Odense, 5000, Denmark

Location

Clinique Rhône Durance

Avignon, 84000, France

Location

Hôpital Pellegrin

Bordeaux, 33076, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

CHU Michalon

Grenoble, 38043, France

Location

Chru Lille

Lille, 59037, France

Location

Hôpital Nord

Marseille, 13915, France

Location

Clinique Beau Soleil

Montpellier, 34000, France

Location

Private practice

Nancy, 54100, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Pasteur

Nice, 06002, France

Location

Hôpital Val de Grâce

Paris, 75005, France

Location

Institut Mutualiste Monsouris

Paris, 75014, France

Location

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

IRCCS Fondazione S. Raffaele del Monte Tabor

Milan, 20132, Italy

Location

AOU San Luigi Gonzaga

Torino, 10043, Italy

Location

P.Stradins Clinical University Hospital

Riga, LV 1002, Latvia

Location

Center of Oncology

Riga, LV1079, Latvia

Location

Medical University Clinics

Kaunas, LT-50009, Lithuania

Location

University Hospital

Klaipėda, Lithuania

Location

University Oncological Institute

Vilnius, LT-08660, Lithuania

Location

Ziekenhuis Amstelland

Amstelveen, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Diaconessenhuis

Leiden, 2333ZA, Netherlands

Location

Antonius Ziekenhuis

Sneek, Netherlands

Location

Medical Center

Arad, Romania

Location

Oncology Institute

Bucharest, 72435, Romania

Location

Sc E-Uro Srl

Cluj-Napoca, Romania

Location

Oncomed

Timișoara, Romania

Location

Hospital Juan Canalejo

A Coruña, 15006, Spain

Location

Hospital Valle Hebrón

Barcelona, 08035, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital de Basurto

Bilbao, 48013, Spain

Location

Hospital General Universitario

Madrid, 28007, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Infanta Sofía

Madrid, 28702, Spain

Location

Instituto de Oncología

Valencia, 46009, Spain

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 8RP, United Kingdom

Location

University Hospital Wales

Cardiff, CF14 4XW, United Kingdom

Location

University Hospital Coventry

Coventry, CV3 / CV2 2DX, United Kingdom

Location

Derby City Hosptial

Derby, DE22 3NE, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Falkirk & District Royal Infirmary

Falkirk, FK1 5QE, United Kingdom

Location

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Lister Hospital

Stevenage, SG1 4AB, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: June 1, 2013
• Last Updated: January 30, 2019
• Results First Posted: July 15, 2015

Record last verified: 2019-01

Locations

FR (15); LI (3); LA (2); BE (6); ES (8); DK (4); RO (4); GB (11); NL (4); IT (2)