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

Prostate Cancer Clinical Trial

— Triptocare  

Official title:

Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020448
• Other study ID #: 8-79-52014-168
• Secondary ID: 2009-012786-58
• Status: Completed
• Phase: Phase 3
• Start date: November 2009
• Est. completion date: June 2013

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: June 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Brussels
Belgium	UCL Saint-Luc	Brussels
Belgium	UZ Brussels	Brussels
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège	Liège
Denmark	Fredericia Sygehus	Fredericia
Denmark	Frederiksbergs Hospital	Frederiksberg
Denmark	Herlev University Hospital	Herlev
Denmark	Odense Universitets hospital	Odense
France	Clinique Rhône Durance	Avignon
France	Hôpital Pellegrin	Bordeaux
France	CHU Henri Mondor	Créteil
France	CHU Michalon	Grenoble
France	Chru Lille	Lille
France	Hôpital Nord	Marseille
France	Clinique Beau Soleil	Montpellier
France	Private practice	Nancy
France	CHU Nantes	Nantes
France	CHU Pasteur	Nice
France	Hôpital Val de Grâce	Paris
France	Institut Mutualiste Monsouris	Paris
France	Hôpital Henry Gabrielle	Saint Genis Laval
France	Hôpital Foch	Suresnes
France	CHU Toulouse	Toulouse
Italy	IRCCS Fondazione S. Raffaele del Monte Tabor	Milano
Italy	AOU San Luigi Gonzaga	Torino
Latvia	Center of Oncology	Riga
Latvia	P.Stradins Clinical University Hospital	Riga
Lithuania	Medical University Clinics	Kaunas
Lithuania	University Hospital	Klaipeda
Lithuania	University Oncological Institute	Vilnius
Netherlands	Ziekenhuis Amstelland	Amstelveen
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Diaconessenhuis	Leiden
Netherlands	Antonius Ziekenhuis	Sneek
Romania	Medical Center	Arad
Romania	Oncology Institute	Bucharest
Romania	Sc E-Uro Srl	Cluj Napoca
Romania	Oncomed	Timisoara
Spain	Hospital Clinic	Barcelona
Spain	Hospital Valle Hebrón	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Juan Canalejo	Coruña
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital General Universitario	Madrid
Spain	Hospital Infanta Sofía	Madrid
Spain	Instituto de Oncología	Valencia
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	University Hospital Wales	Cardiff
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Derby City Hosptial	Derby
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Falkirk & District Royal Infirmary	Falkirk
United Kingdom	Leicester General Hospital	Leicester
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Lister Hospital	Stevenage

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Italy,  Latvia,  Lithuania,  Netherlands,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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; 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	PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA 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 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.'	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)		At month 1, 3 and 6 post-treatment
Secondary	PSA Level		At baseline, month 1, 3 and 6 post-treatment
Secondary	Safety, Assessed Through the Collection of Adverse Events (AEs)		For the duration of the study (up to month 6)