Clinical trial NCT05759273: A Study to Observe Demography and the Outcome of Prostate Cancer Patients Treated With 6-month Triptorelin Formulation in Italy
Official title: Retrospective, Noninterventional Study Assessing the Real-Life Use of The Long-Acting 6-Month Triptorelin Formulation as A Treatment for Different Stages of Prostate Cancer in Italy - REAL6T
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 167
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is planned to include participants with different stages of prostate cancer excluding low risks and localised prostate cancer, in whom a decision to treat with the 6-month triptorelin formulation had been made before the start of this study and as guided by Italy's label for Decapeptyl®. Eligible participants may or may not have had previous treatment with other LHRH analogues and triptorelin formulations except the 6-month triptorelin formulation.

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.


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;
* Do not fulfil all the inclusion criteria.

Primary outcomes:
measure: Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated
timeFrame: Before first Injection (before day 1)
measure: Demographic Characteristic: Age of Participants
timeFrame: Before first Injection (before day 1)
measure: Demographic Characteristic: Body Mass Index (BMI)
timeFrame: Before first Injection (before day 1)
measure: Testosterone Levels
timeFrame: Before first Injection (before day 1)
measure: Tumor Characteristics as Evaluated by Eastern Cooperative Oncology Group (ECOG) Score
timeFrame: Before first Injection (before day 1)
measure: Tumor Characteristics as Evaluated by Tumor Node Metastasis (TNM) Staging System
timeFrame: Before first Injection (before day 1)
measure: Tumor Characteristics as Evaluated by Grade Group and/or Gleason Score
timeFrame: Before first Injection (before day 1)
measure: Prostate Cancer-specific Antigen(PSA) Levels
timeFrame: Before first Injection (before day 1)
measure: Describe Data of Participants with Prostate Cancer History
timeFrame: Before first Injection (before day 1)
Secondary outcomes:
measure: Reasons for Choosing the 6-month Triptorelin Formulation
timeFrame: From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
measure: Percentage of Participants who Either Permanently or Temporarily Discontinued 6-month Triptorelin Formulation
timeFrame: From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
measure: Duration of Treatment with 6-month Triptorelin Formulation
timeFrame: From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
measure: Percentage of Participants whose Serum Testosterone Levels Presented Castration Levels (testosterone levels <50 nanograms per deciliter)
timeFrame: From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
measure: Percentage of Participants Using Prostate Cancer-related Concomitant Therapies
timeFrame: From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
measure: Prostate Cancer-specific Antigen (PSA) Levels
timeFrame: At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
measure: Percentage of Participants who Switched to 6-month Triptorelin Formulation From the 3-Month Triptorelin Formulation or Another LHRH Analogue
timeFrame: At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
measure: Percentage of Participants who Switched to the 3-month triptorelin Formulation or Another Luteinizing Hormone-releasing Hormone (LHRH) Analogue from 6-month formulation
timeFrame: At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
measure: Potential Factors Predictive of any Treatment Switch
timeFrame: At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
measure: Percentage of Participants who Were Noncastrated or Castration-naïve and who Presented Serum Testosterone Levels Corresponding to Castration
timeFrame: Day 45 up to 6 months after the last injection with this product
measure: Percentage of Participants Whose Serum Testosterone Levels Never Reached Castration Levels
timeFrame: During treatment with the 6-month formulation (approximatively three years of existing participants data).
measure: Percentage of Participants With Triptorelin-related Adverse events (AEs), Serious Adverse Events (SAEs), Non-SAEs and as well as Special Situations AEs
timeFrame: From first injection (at day 1) with the 6-month formulation up to 6 months after the last injection with this product.
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
city: Catania
country: Italy
facility: AOU Policlinico "Gaspare Rodolico"
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Latina
country: Italy
facility: Ospedale ICOT
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore-Don Calabria, Cancer Care Center Negrar
city: Palermo
country: Italy
facility: Ospedale Buccheri La Ferla Fatebenefratelli di Palermo
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Pozzuoli
country: Italy
facility: Ospedale Santa Maria delle Grazia
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Sant'Andrea
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: San Fermo della Battaglia
country: Italy
facility: Ospedale Sant'Anna
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: