Prostate CancerTALISMANNCT04593420
Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.
An observational study of Prostate Cancer, run by Ipsen at 1 site in France.
Trial summary
The purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. This study will take place at 187 locations (approximately) in France. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 817 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2020to 8 Dec 2022
- 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 18 years and older
- Men only
- Adult, Older adult
Study population: 786 subjects presenting a prostate cancer histologically confirmed and eligible to start triptorelin treatment for at least 12 months will be included in the study. They should also be able to complete a self-questionnaire.
Who may be able to join
- At least 18 years old
- Histologically confirmed prostate cancer
- Triptorelin to be initiated in its labelled indication for a planned total duration of at least 12 months; decision to start triptorelin was made voluntarily by the physician as part of routine medical practice, prior to the inclusion in the study
- Ability to understand and complete questionnaire,
Who cannot join
- Previously received a hormonal therapy during the last 6 months before inclusion,
- Simultaneously participates in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. This study will take place at 187 locations (approximately) in France.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects treated continuously with triptorelin for the 12 months
The proportion of subjects treated continuously with triptorelin for the 12 months following treatment initiation, with any formulation and any route of administration. The treatment status (i.e. patient continuously treated / patient not continuously treated) will be assessed according to the investigator's judgment.
Measured: 12 months
Secondary outcomes (8)
Planned total duration of triptorelin treatment
Measured: Baseline, 6 months, 12 months
Primary reasons of choice of planned total triptorelin treatment duration
Description of the primary reason of choice of planned total triptorelin treatment duration declared by the investigator, at V1; and at V2 and V3 if the planned total duration is modified.
Measured: baseline, 6 month, 12 months
Parameters that influence the planned total duration of triptorelin treatment
Identification of parameters that influence the planned total duration of triptorelin treatment including but not limited to the following parameters: Circumstance of prescription, Prostate Cancer (PCa) aggressiveness criteria, Prior PCa treatments, Concomitant PCa treatments, Subject's characteristics: age, weight, Karnofsky score, specific comorbidities and concomitant treatments, genetic predisposition.
Measured: Baseline
Parameters that influence the modification of the planned total duration of triptorelin treatment
Identification of parameters that influence the modification (if any) of the planned total duration of triptorelin treatment including but not limited to the following parameters: PCa aggressiveness criteria at 12 months (PSA, concomitant treatments for prostate cancer, symptoms, metastases assessment), Subject's characteristics: age, weight, Karnofsky score, specific comorbidities and concomitant treatments, genetic predisposition at baseline, follow up assessments, care pathway.
Measured: 12 months
Formulation and administration route of triptorelin prescribed
Formulation and administration route of triptorelin prescribed (monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular).
Measured: baseline, 6 and 12 months
Description of the reasons of choice of formulation and administration route of triptorelin prescribed
monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular) at V1, according to the investigator.
Measured: baseline
Parameters that influence the choice of formulation and administration route of triptorelin prescribed
Identification of parameters that influence the choice of formulation and administration route of triptorelin prescribed (monthly intramuscular, 3-monthly subcutaneous, 3-monthly intramuscular, 6-monthly intramuscular) at V1 including but not limited to the following parameters: Disease with symptoms, total planned duration of treatment, highly evolutive disease, heavy PCa concomitant treatment, physical frailty of subjects, psychological context of subjects, potential impact on compliance, subject afraid of injection, anticoagulant treatment, BMI, Preferred investigator formulation/route
Measured: baseline
Description and change at each follow-up visit from baseline
Description and change at each follow-up visit (V2, V3) from baseline (V1) in each of the 6 sub-scales of the QLQ-PR25 questionnaire (urinary symptoms, incontinence aid, bowel symptoms; treatment related symptoms, sexual activity, sexual functioning). QLQ-PR25 score is distributed from 1 (not at all) to 4 (very much).
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start30 Nov 2020
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 817 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
- NCT04593420
- Sponsor's protocol ID
- A-FR-52014-241
- Acronym
- TALISMAN
- Status last verified
- Dec 2022
- First submitted
- 13 Oct 2020
- Last updated
- 21 Dec 2022
- 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.
Publications
Lebret T, Crehange G, Pello-Leprince-Ringuet N, Perrot V, Rigaud J. Treatment of aggressive prostate cancer with triptorelin in real life in France: the TALISMAN study. Ther Adv Urol. 2025 Oct 15;17:17562872251382970. doi: 10.1177/17562872251382970. eCollection 2025 Jan-Dec.
PubMed 41122488
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.
- ClinicalTrials.gov ID
- NCT04593420
- Acronym / sponsor ID
- TALISMAN / A-FR-52014-241
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 20 Oct 2020 (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 purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. This study will take place at 187 locations (approximately) in France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- 786 subjects presenting a prostate cancer histologically confirmed and eligible to start triptorelin treatment for at least 12 months will be included in the study. They should also be able to complete a self-questionnaire.
Key inclusion criteria (4 listed)
- At least 18 years old
- Histologically confirmed prostate cancer
- Triptorelin to be initiated in its labelled indication for a planned total duration of at least 12 months; decision to start triptorelin was made voluntarily by the physician as part of routine medical practice, prior to the inclusion in the study
- Ability to understand and complete questionnaire,
Key exclusion criteria (2 listed)
- Previously received a hormonal therapy during the last 6 months before inclusion,
- Simultaneously participates in a clinical trial.
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
Proportion of subjects treated continuously with triptorelin for the 12 months
Time frame: 12 months
The proportion of subjects treated continuously with triptorelin for the 12 months following treatment initiation, with any formulation and any route of administration. The treatment status (i.e. patient continuously treated / patient not continuously treated) will be assessed according to the investigator's judgment.
8 secondary outcomes
Planned total duration of triptorelin treatment
Time frame: Baseline, 6 months, 12 months
Primary reasons of choice of planned total triptorelin treatment duration
Time frame: baseline, 6 month, 12 months
Parameters that influence the planned total duration of triptorelin treatment
Time frame: Baseline
Parameters that influence the modification of the planned total duration of triptorelin treatment
Time frame: 12 months
Formulation and administration route of triptorelin prescribed
Time frame: baseline, 6 and 12 months
Description of the reasons of choice of formulation and administration route of triptorelin prescribed
Time frame: baseline
Parameters that influence the choice of formulation and administration route of triptorelin prescribed
Time frame: baseline
Description and change at each follow-up visit from baseline
Time frame: baseline, 6 months, 12 months
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 21 Dec 2022.
- Derived from this study: PubMed 41122488Lebret T, Crehange G, Pello-Leprince-Ringuet N, Perrot V, Rigaud J. Treatment of aggressive prostate cancer with triptorelin in real life in France: the TALISMAN study. Ther Adv Urol. 2025 Oct 15;17:17562872251382970. doi: 10.1177/17562872251382970. eCollection 2025 Jan-Dec.
- 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
1 site 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 1 site in France.
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 4 inclusion and 2 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 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Proportion of subjects treated continuously with triptorelin for the 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593420, which also lists 1 linked publication.
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 21 Dec 2022.