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

NCT05759273 | Completed

• 1 other identifier: CLIN-52014-454
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 13

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (12)

• 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

  From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product

Study Arms (1)

Triptorelin 6 Month Formulation

Participants treated with the 6-month triptorelin formulation

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ipsen: lead

Study Sites (13)

Humanitas Gavazzeni

Bergamo, 24125, Italy

Location

AOU Policlinico "Gaspare Rodolico"

Catania, 95123, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Ospedale ICOT

Latina, 04100, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

IRCCS Ospedale Sacro Cuore-Don Calabria, Cancer Care Center Negrar

Negrar, 37024, Italy

Location

Ospedale Buccheri La Ferla Fatebenefratelli di Palermo

Palermo, 90123, Italy

Location

Ospedale Santa Maria della Misericordia

Perugia, 06132, Italy

Location

Ospedale Santa Maria delle Grazia

Pozzuoli, 80078, Italy

Location

Azienda Ospedaliera Universitaria Sant'Andrea

Roma, 00189, Italy

Location

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Ospedale Sant'Anna

San Fermo della Battaglia, 22042, Italy

Location

Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 8, 2023
• Study Start: April 24, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Locations

IT (13)