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.
Study Type
OBSERVATIONAL
Enrollment
167
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
...and 3 more locations
Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated
Time frame: Before first Injection (before day 1)
Demographic Characteristic: Age of Participants
The age of study participants will be reported.
Time frame: Before first Injection (before day 1)
Demographic Characteristic: Body Mass Index (BMI)
BMI of study participants will be reported.
Time frame: Before first Injection (before day 1)
Testosterone Levels
Participants serum testosterone levels will be assessed.
Time frame: Before first Injection (before day 1)
Tumor Characteristics as Evaluated by Eastern Cooperative Oncology Group (ECOG) Score
Tumor characteristics, collected by ECOG Score at the nearest visit just before the injection.
Time frame: Before first Injection (before day 1)
Tumor Characteristics as Evaluated by Tumor Node Metastasis (TNM) Staging System
Tumor characteristics, collected by TNM staging system at the nearest visit just before the injection.
Time frame: Before first Injection (before day 1)
Tumor Characteristics as Evaluated by Grade Group and/or Gleason Score
Tumor characteristics, collected by Grade Group and/or Gleason Score at the nearest visit just before the injection.
Time frame: Before first Injection (before day 1)
Prostate Cancer-specific Antigen(PSA) Levels
Time frame: Before first Injection (before day 1)
Describe Data of Participants with Prostate Cancer History
Describe Data including primary treatment or active surveillance, and other therapies.
Time frame: Before first Injection (before day 1)
Reasons for Choosing the 6-month Triptorelin Formulation
Time frame: From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
Percentage of Participants who Either Permanently or Temporarily Discontinued 6-month Triptorelin Formulation
Time frame: From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
Duration of Treatment with 6-month Triptorelin Formulation
Time frame: 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)
Time frame: 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
Concomitant therapies are defined such as combined treatments (chemotherapy and/or androgen receptor targeted agents (ARTAs; enzalutamide, abiraterone, etc.) and/or radiotherapy.
Time frame: 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
Time frame: 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
Percentage of participants who switched the treatment along with the reasons for switching the treatment will be reported.
Time frame: At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage of Participants who Switched to the 3-month triptorelin Formulation or Another Luteinizing Hormone-releasing Hormone (LHRH) Analogue from 6-month formulation
Percentage of participants who switched the treatment along with the reasons for switching the treatment will be reported.
Time frame: 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 Predictive of any Treatment Switch
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.
Time frame: 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 Were Noncastrated or Castration-naïve and who Presented Serum Testosterone Levels Corresponding to Castration
Castration is defined as a testosterone level \<50 ng/dL among all testosterone evaluations available in the participants' medical files
Time frame: Day 45 up to 6 months after the last injection with this product
Percentage of Participants Whose Serum Testosterone Levels Never Reached Castration Levels
Castration is defined as a testosterone level \<50 ng/dL among all testosterone evaluations available in the participants medical files.
Time frame: During treatment with the 6-month formulation (approximatively three years of existing participants data).
Percentage of Participants With Triptorelin-related Adverse events (AEs), Serious Adverse Events (SAEs), Non-SAEs and as well as Special Situations AEs
Time frame: From first injection (at day 1) with the 6-month formulation up to 6 months after the last injection with this product.