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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05759273




Registration number
NCT05759273
Ethics application status
Date submitted
17/02/2023
Date registered
8/03/2023

Titles & IDs
Public title
A Study to Observe Demography and the Outcome of Prostate Cancer Patients Treated With 6-month Triptorelin Formulation in Italy
Scientific 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
Secondary ID [1] 0 0
CLIN-52014-454
Universal Trial Number (UTN)
Trial acronym
REAL6T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Triptorelin 6 Month Formulation - Participants treated with the 6-month triptorelin formulation
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated
Timepoint [1] 0 0
Before first Injection (before day 1)
Primary outcome [2] 0 0
Demographic Characteristic: Age of Participants
Timepoint [2] 0 0
Before first Injection (before day 1)
Primary outcome [3] 0 0
Demographic Characteristic: Body Mass Index (BMI)
Timepoint [3] 0 0
Before first Injection (before day 1)
Primary outcome [4] 0 0
Testosterone Levels
Timepoint [4] 0 0
Before first Injection (before day 1)
Primary outcome [5] 0 0
Tumor Characteristics as Evaluated by Eastern Cooperative Oncology Group (ECOG) Score
Timepoint [5] 0 0
Before first Injection (before day 1)
Primary outcome [6] 0 0
Tumor Characteristics as Evaluated by Tumor Node Metastasis (TNM) Staging System
Timepoint [6] 0 0
Before first Injection (before day 1)
Primary outcome [7] 0 0
Tumor Characteristics as Evaluated by Grade Group and/or Gleason Score
Timepoint [7] 0 0
Before first Injection (before day 1)
Primary outcome [8] 0 0
Prostate Cancer-specific Antigen(PSA) Levels
Timepoint [8] 0 0
Before first Injection (before day 1)
Primary outcome [9] 0 0
Describe Data of Participants with Prostate Cancer History
Timepoint [9] 0 0
Before first Injection (before day 1)
Secondary outcome [1] 0 0
Reasons for Choosing the 6-month Triptorelin Formulation
Timepoint [1] 0 0
From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
Secondary outcome [2] 0 0
Percentage of Participants who Either Permanently or Temporarily Discontinued 6-month Triptorelin Formulation
Timepoint [2] 0 0
From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
Secondary outcome [3] 0 0
Duration of Treatment with 6-month Triptorelin Formulation
Timepoint [3] 0 0
From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
Secondary outcome [4] 0 0
Percentage of Participants whose Serum Testosterone Levels Presented Castration Levels (testosterone levels <50 nanograms per deciliter)
Timepoint [4] 0 0
From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
Secondary outcome [5] 0 0
Percentage of Participants Using Prostate Cancer-related Concomitant Therapies
Timepoint [5] 0 0
From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product
Secondary outcome [6] 0 0
Prostate Cancer-specific Antigen (PSA) Levels
Timepoint [6] 0 0
At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
Secondary outcome [7] 0 0
Percentage of Participants who Switched to 6-month Triptorelin Formulation From the 3-Month Triptorelin Formulation or Another LHRH Analogue
Timepoint [7] 0 0
At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
Secondary outcome [8] 0 0
Percentage of Participants who Switched to the 3-month triptorelin Formulation or Another Luteinizing Hormone-releasing Hormone (LHRH) Analogue from 6-month formulation
Timepoint [8] 0 0
At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
Secondary outcome [9] 0 0
Potential Factors Predictive of any Treatment Switch
Timepoint [9] 0 0
At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product
Secondary outcome [10] 0 0
Percentage of Participants who Were Noncastrated or Castration-naïve and who Presented Serum Testosterone Levels Corresponding to Castration
Timepoint [10] 0 0
Day 45 up to 6 months after the last injection with this product
Secondary outcome [11] 0 0
Percentage of Participants Whose Serum Testosterone Levels Never Reached Castration Levels
Timepoint [11] 0 0
During treatment with the 6-month formulation (approximatively three years of existing participants data).
Secondary outcome [12] 0 0
Percentage of Participants With Triptorelin-related Adverse events (AEs), Serious Adverse Events (SAEs), Non-SAEs and as well as Special Situations AEs
Timepoint [12] 0 0
From first injection (at day 1) with the 6-month formulation up to 6 months after the last injection with this product.

Eligibility
Key inclusion 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;
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Bergamo
Country [2] 0 0
Italy
State/province [2] 0 0
Catania
Country [3] 0 0
Italy
State/province [3] 0 0
Firenze
Country [4] 0 0
Italy
State/province [4] 0 0
Latina
Country [5] 0 0
Italy
State/province [5] 0 0
Napoli
Country [6] 0 0
Italy
State/province [6] 0 0
Negrar
Country [7] 0 0
Italy
State/province [7] 0 0
Palermo
Country [8] 0 0
Italy
State/province [8] 0 0
Perugia
Country [9] 0 0
Italy
State/province [9] 0 0
Pozzuoli
Country [10] 0 0
Italy
State/province [10] 0 0
Roma
Country [11] 0 0
Italy
State/province [11] 0 0
Rozzano
Country [12] 0 0
Italy
State/province [12] 0 0
San Fermo della Battaglia
Country [13] 0 0
Italy
State/province [13] 0 0
Udine

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ipsen Recruitment Enquiries
Address 0 0
Country 0 0
Phone 0 0
see email
Fax 0 0
Email 0 0
clinical.trials@ipsen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05759273