A Study to Observe Demography and the Outcome of Prostate Cancer Patients Treated With 6-month Triptorelin Formulation in Italy

NCT ID: NCT05759273

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2024-09-30

Brief Summary

The participants of this study had Prostate Cancer. Prostate cancer is cancer that occurs in the prostate, a small gland in the male reproductive system. This study will collect data on the use of the 6-month triptorelin formulation (Decapeptyl®) in local routine clinical practice as a treatment for different stages of prostate cancer. The aim of this study will be to describe participant characteristics, as well as disease and treatment characteristics before the first injection with the 6-month triptorelin formulation in Italy. The decision to prescribe this product and all hospital visits, dose adjustments, assessments and procedures were made according to routine clinical practice at the time and independently of the decision to enroll the participants in this data collection study.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Triptorelin 6 Month Formulation

Participants treated with the 6-month triptorelin formulation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participants must have a documented diagnosis of prostate cancer, as per the following disease status groups: - participants with intermediate risk prostate cancer with indication to radiotherapy treated with neoadjuvant and concomitant hormonal therapy; - participants with high risk prostate cancer after radical prostatectomy or radiotherapy, treated with adjuvant hormonal therapy; - participants with advanced/metastatic prostate cancer treated with long-term hormonal therapy; - participants treated with primary therapy (i.e. surgery or radiotherapy) with biochemical recurrence; - participants with castration-resistant prostate cancer;
• Participants must have received a minimum of one injection with the 6 month triptorelin formulation according to this product's local label, during the participant identification period;
• Participants must have a minimum of 6 months of follow-up data recorded on their medical files after the first injection with the 6-month formulation, and until death or 06 July 2022, whichever comes first;
• Participants may have received previous treatment with an LHRH analogue;
• Participants must have at least one document analysis of PSA levels recorded before the injection with the 6-month formulation;
• Participants with castration status achieved with any LHRH analogue who switched to the 6-month triptorelin formulation must have a minimum of two documented analysis of testosterone levels: (a) one performed before the first ever injection with the 6-month formulation, if available, and one performed during the period covered by treatment with this formulation to confirm castration maintenance in the participant SMD form protocol master data-OBS / Version 1 OR (b) both analyses performed during the period covered by treatment with this formulation;
• Noncastrated participants or castration-naïve participants must have a minimum of two documented analysis of testosterone levels: (a) one performed before the first ever injection with the 6-month formulation, if available, and one performed during the period covered by the treatment with this formulation to confirm that castration status has been reached; OR (b) both analyses performed during the period covered by treatment with this formulation. Note: if available, another testosterone analysis performed during the period covered by the treatment with this formulation will also be collected to confirm that castration status was maintained in the participant; Note: A noncastrated participant is defined as a participant who was not receiving any testosterone-blocking treatment at the time of the first injection with the 6-month triptorelin formulation but had history of previous ADT agents. A castration-naïve participant is defined as a participant that never received any testosterone-blocking treatment prior to the first injection with the 6-month formulation.
• Provision of written ICF to the extent required according to applicable national local regulations for a retrospective, noninterventional study;

Exclusion Criteria

• Have missing PSA data before having received the first injection with the 6 month triptorelin formulation;
• Were diagnosed with low-risk or localised prostate cancer;

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Humanitas Gavazzeni

Bergamo, , Italy

AOU Policlinico "Gaspare Rodolico"

Catania, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Ospedale ICOT

Latina, , Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

IRCCS Ospedale Sacro Cuore-Don Calabria, Cancer Care Center Negrar

Negrar, , Italy

Ospedale Buccheri La Ferla Fatebenefratelli di Palermo

Palermo, , Italy

Ospedale Santa Maria della Misericordia

Perugia, , Italy

Ospedale Santa Maria delle Grazia

Pozzuoli, , Italy

Azienda Ospedaliera Universitaria Sant'Andrea

Roma, , Italy

IRCCS Istituto Clinico Humanitas

Rozzano, , Italy

Ospedale Sant'Anna

San Fermo della Battaglia, , Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, , Italy

Countries

Italy

Other Identifiers

CLIN-52014-454

Identifier Type: -

Identifier Source: org_study_id