A Study to Observe Demography and the Outcome of Prostate Cancer Patients Treated With 6-month Triptorelin Formulation in Italy (REAL6T)

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

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 Overview

• Status: Completed
• Conditions: Prostate Cancer

• Study Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24125
    • Humanitas Gavazzeni
  • Catania, Italy, 95123
    • AOU Policlinico "Gaspare Rodolico"
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Latina, Italy, 04100
    • Ospedale ICOT
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Negrar, Italy, 37024
    • IRCCS Ospedale Sacro Cuore-Don Calabria, Cancer Care Center Negrar
  • Palermo, Italy, 90123
    • Ospedale Buccheri La Ferla Fatebenefratelli di Palermo
  • Perugia, Italy, 06132
    • Ospedale Santa Maria Della Misericordia
  • Pozzuoli, Italy, 80078
    • Ospedale Santa Maria delle Grazia
  • Roma, Italy, 00189
    • Azienda Ospedaliera Universitaria Sant'Andrea
  • Rozzano, Italy, 20089
    • IRCCS Istituto Clinico Humanitas
  • San Fermo della Battaglia, Italy, 22042
    • Ospedale Sant'Anna
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Friuli Centrale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Triptorelin 6 Month Formulation; Participants treated with the 6-month triptorelin formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The age of study participants will be reported.	Before first Injection (before day 1)
Demographic Characteristic: Body Mass Index (BMI)	BMI of study participants will be reported.	Before first Injection (before day 1)
Testosterone Levels	Participants serum testosterone levels will be assessed.	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.	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.	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.	Before first Injection (before day 1)
Prostate Cancer-specific Antigen(PSA) Levels		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.	Before first Injection (before day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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	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
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
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
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
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).
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.

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CLIN-52014-454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).