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

Prostate Cancer Clinical Trial

— REAL6T  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759273
• Other study ID #: CLIN-52014-454
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Ipsen
• Contact: Ipsen Recruitment Enquiries
• Phone: see email
• Email: clinical.trials[@]ipsen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated		Before first Injection (before day 1)
Primary	Demographic Characteristic: Age of Participants	The age of study participants will be reported.	Before first Injection (before day 1)
Primary	Demographic Characteristic: Body Mass Index (BMI)	BMI of study participants will be reported.	Before first Injection (before day 1)
Primary	Testosterone Levels	Participants serum testosterone levels will be assessed.	Before first Injection (before day 1)
Primary	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.	Before first Injection (before day 1)
Primary	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.	Before first Injection (before day 1)
Primary	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.	Before first Injection (before day 1)
Primary	Prostate Cancer-specific Antigen(PSA) Levels		Before first Injection (before day 1)
Primary	Describe Data of Participants with Prostate Cancer History	Describe Data including primary treatment or active surveillance, and other therapies.	Before first Injection (before day 1)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
Secondary	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
Secondary	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.	At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
Secondary	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.	At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
Secondary	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.	At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
Secondary	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	Day 45 up to 6 months after the last injection with this product
Secondary	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.	During treatment with the 6-month formulation (approximatively three years of existing participants data).
Secondary	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.