Prostate CancerREAL6TNCT05759273
A Study to Observe Demography and the Outcome of Prostate Cancer Patients Treated With 6-month Triptorelin Formulation in Italy
An observational study of Prostate Cancer, run by Ipsen at 13 sites in Italy.
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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 167 participants
- Where
- 13 sitesItaly
- Study dates
- 24 Apr 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Humanitas Gavazzeni
Bergamo, 24125
AOU Policlinico "Gaspare Rodolico"
Catania, 95123
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Ospedale ICOT
Latina, 04100
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
IRCCS Ospedale Sacro Cuore-Don Calabria, Cancer Care Center Negrar
Negrar, 37024
Ospedale Buccheri La Ferla Fatebenefratelli di Palermo
Palermo, 90123
Ospedale Santa Maria della Misericordia
Perugia, 06132
Ospedale Santa Maria delle Grazia
Pozzuoli, 80078
Azienda Ospedaliera Universitaria Sant'Andrea
Roma, 00189
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Ospedale Sant'Anna
San Fermo della Battaglia, 22042
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
About this study
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
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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin 6 Month Formulation | Participants treated with the 6-month triptorelin formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated
Measured: Before first Injection (before day 1)
Demographic Characteristic: Age of Participants
The age of study participants will be reported.
Measured: Before first Injection (before day 1)
Demographic Characteristic: Body Mass Index (BMI)
BMI of study participants will be reported.
Measured: Before first Injection (before day 1)
Testosterone Levels
Participants serum testosterone levels will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before first Injection (before day 1)
Prostate Cancer-specific Antigen(PSA) Levels
Measured: 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.
Measured: Before first Injection (before day 1)
Secondary outcomes (12)
Reasons for Choosing the 6-month Triptorelin Formulation
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: From first injection (at day 1) with the 6-month formulation up to 6 months after the last injection with this product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start24 Apr 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759273
- Sponsor's protocol ID
- CLIN-52014-454
- Acronym
- REAL6T
- Status last verified
- Oct 2024
- First submitted
- 17 Feb 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05759273
- Acronym / sponsor ID
- REAL6T / CLIN-52014-454
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triptorelin 6 Month Formulation | – | –Participants treated with the 6-month triptorelin formulation |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated
Time frame: Before first Injection (before day 1)
Demographic Characteristic: Age of Participants
Time frame: Before first Injection (before day 1)
The age of study participants will be reported.
Demographic Characteristic: Body Mass Index (BMI)
Time frame: Before first Injection (before day 1)
BMI of study participants will be reported.
Testosterone Levels
Time frame: Before first Injection (before day 1)
Participants serum testosterone levels will be assessed.
Tumor Characteristics as Evaluated by Eastern Cooperative Oncology Group (ECOG) Score
Time frame: Before first Injection (before day 1)
Tumor characteristics, collected by ECOG Score at the nearest visit just before the injection.
Tumor Characteristics as Evaluated by Tumor Node Metastasis (TNM) Staging System
Time frame: Before first Injection (before day 1)
Tumor characteristics, collected by TNM staging system at the nearest visit just before the injection.
Tumor Characteristics as Evaluated by Grade Group and/or Gleason Score
Time frame: Before first Injection (before day 1)
Tumor characteristics, collected by Grade Group and/or Gleason Score at the nearest visit just before the injection.
Prostate Cancer-specific Antigen(PSA) Levels
Time frame: Before first Injection (before day 1)
Describe Data of Participants with Prostate Cancer History
Time frame: Before first Injection (before day 1)
Describe Data including primary treatment or active surveillance, and other therapies.
12 secondary outcomes
Reasons for Choosing the 6-month Triptorelin Formulation
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 45 up to 6 months after the last injection with this product
Percentage of Participants Whose Serum Testosterone Levels Never Reached Castration Levels
Time frame: 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
Time frame: From first injection (at day 1) with the 6-month formulation up to 6 months after the last injection with this product.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Ipsen at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated (time frame: Before first Injection (before day 1)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.