A Study to Observe Demography and the Outcome of Prostate Cancer Patients Treated With 6-month Triptorelin Formulation in Italy
- Conditions
- Prostate Cancer
- Registration Number
- NCT05759273
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 167
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demographic Characteristic: Body Mass Index (BMI) Before first Injection (before day 1) BMI of study participants will be reported.
Prostate Cancer-specific Antigen(PSA) Levels Before first Injection (before day 1) Tumor Characteristics as Evaluated by Eastern Cooperative Oncology Group (ECOG) Score Before first Injection (before day 1) Tumor characteristics, collected by ECOG Score at the nearest visit just before the injection.
Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated Before first Injection (before day 1) Demographic Characteristic: Age of Participants Before first Injection (before day 1) The age of study participants will be reported.
Testosterone Levels Before first Injection (before day 1) Participants serum testosterone levels will be assessed.
Tumor Characteristics as Evaluated by Tumor Node Metastasis (TNM) Staging System Before first Injection (before day 1) Tumor characteristics, collected by TNM staging system at the nearest visit just before the injection.
Tumor Characteristics as Evaluated by Grade Group and/or Gleason Score Before first Injection (before day 1) Tumor characteristics, collected by Grade Group and/or Gleason Score at the nearest visit just before the injection.
Describe Data of Participants with Prostate Cancer History Before first Injection (before day 1) Describe Data including primary treatment or active surveillance, and other therapies.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Triptorelin-related Adverse events (AEs), Serious Adverse Events (SAEs), Non-SAEs and as well as Special Situations AEs From first injection (at day 1) with the 6-month formulation up to 6 months after the last injection with this product. Reasons for Choosing the 6-month Triptorelin Formulation From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product Prostate Cancer-specific Antigen (PSA) Levels At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product Percentage of Participants who Switched to 6-month Triptorelin Formulation From the 3-Month Triptorelin Formulation or Another LHRH Analogue At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product Percentage of participants who switched the treatment along with the reasons for switching the treatment will be reported.
Percentage of Participants who Either Permanently or Temporarily Discontinued 6-month Triptorelin Formulation From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product Percentage of Participants Using Prostate Cancer-related Concomitant Therapies From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product Concomitant therapies are defined such as combined treatments (chemotherapy and/or androgen receptor targeted agents (ARTAs; enzalutamide, abiraterone, etc.) and/or radiotherapy.
Percentage of Participants who Switched to the 3-month triptorelin Formulation or Another Luteinizing Hormone-releasing Hormone (LHRH) Analogue from 6-month formulation At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product Percentage of participants who switched the treatment along with the reasons for switching the treatment will be reported.
Percentage of Participants Whose Serum Testosterone Levels Never Reached Castration Levels During treatment with the 6-month formulation (approximatively three years of existing participants data). Castration is defined as a testosterone level \<50 ng/dL among all testosterone evaluations available in the participants medical files.
Duration of Treatment with 6-month Triptorelin Formulation From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product Percentage of Participants whose Serum Testosterone Levels Presented Castration Levels (testosterone levels <50 nanograms per deciliter) From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product Potential Factors Predictive of any Treatment Switch At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product Potential factors such as PSA levels, prostate cancer aggressiveness criteria (based on tumor histological assessment), age, BMI, physical condition (ECOG scale), comorbidities, etc.) leading to treatment switch will be identified.
Percentage of Participants who Were Noncastrated or Castration-naïve and who Presented Serum Testosterone Levels Corresponding to Castration Day 45 up to 6 months after the last injection with this product Castration is defined as a testosterone level \<50 ng/dL among all testosterone evaluations available in the participants' medical files
Trial Locations
- Locations (13)
Humanitas Gavazzeni
🇮🇹Bergamo, Italy
AOU Policlinico "Gaspare Rodolico"
🇮🇹Catania, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, 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