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Prostate CancerPhase 3TriptoSwitchNCT05458856

Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate

A Phase 3 study testing Triptorelin embonate 22.5 mg in people with Prostate Cancer, run by Ipsen at 39 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Triptorelin embonate 22.5 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
39 sitesin 7 countries
Study dates
30 Aug 2022to 8 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is male and must be 18 years of age inclusive, at the time of signing the informed consent
  • Participant has histologically or cytologically proven prostate cancer with rising PSA after failed local therapy or metastatic disease, or requiring radiotherapy, and be a candidate for long-term (i.e. >1 year) androgen deprivation therapy
  • Participant requires a GnRH analogue treatment for a minimum of 18 months, of which a minimum of 3 months of GnRH analogue treatment has already been provided prior to screening. (Note: participants must receive study intervention on Day 1 in accordance with the treatment schedule of their previously received GnRH analogue therapy).
  • Has serum testosterone levels <1.735 nmol/L (50 ng/dL) at screening
  • Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
  • Has a life expectancy of >18 months
  • Male participants must agree that, if their partner is at risk of becoming pregnant (although highly unlikely in this study population), they will use an effective method of contraception. The participant must agree to use the contraception during the whole of the study and for 9 months after the last dose of study intervention
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Who cannot join

  • Presence of another neoplastic lesion or brain metastases
  • Metastatic hormone-sensitive prostate cancer with high tumour burden
  • Metastatic castration-resistant prostate cancer
  • Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance or with the study in the opinion of the investigator
  • Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the past 6 months
  • Planned intermittent scheme of GnRH analogue
Show all 15Show fewer
  • At the time of screening, planned use of any chemotherapy for prostate cancer during the study
  • Prior hypophysectomy or adrenalectomy
  • Participation in another study with an experimental drug within 3 months before signing informed consent or within five half-lives of the investigational drug (whichever was the longer), or any other type of medical research
  • Severe kidney or liver failure (creatinine >2 times the normal range, aspartate aminotransferase and alanine aminotransferase >3 times the normal range)
  • Any concomitant disorder or resulting therapy that is likely to interfere with participant's compliance, the subcutaneous administration of the drug or with the study in the opinion of the investigator
  • Previous history of QT prolongation or concomitant use of medicinal products known to prolong the QT interval or with a known risk of torsades de pointes
  • Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues
  • Known active use of recreational drug or alcohol dependence in the opinion of the investigator
  • Inability to give informed consent or to comply fully with the protocol

Trial locations and contacts

39 sites in 7 countries.

39 sites in 7 countries

France11 sites

  • Centre Hospitalier Universitaire D'Angers - Urologie

    Angers, 49933

  • CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat

    Brest, 29200

  • Clinique Pasteur-Lanroze - Oncology

    Brest, 29229

  • Polyclinique de Blois - Service oncologie

    La Chaussée-Saint-Victor, 41260

  • Hopital Privé Métropole Lille - Polyclinique Du Bois

    Lille, 59000

  • CHU Hopital Edouard Herriot

    Lyon, 69437

  • L'Institut Mutualiste Montsouris

    Paris, 75014

  • Hopital Bichat

    Paris, 75018

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Foch - Urologie et Transplantation Ré

    Suresnes, 92151

  • Saint Jean Languedoc and La Croix du Sud Hospital

    Toulouse, 31400

Other trials in France

Spain8 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital de La Santa Creu i Sant Pau - Oncología Médica

    Barcelona, 08041

  • H. de Basurto - Urología

    Bilbao, 48013

  • POLUSA - Policlínico Lucense - Oncología

    Lugo, 27004

  • Hospital Universitario 12 de Octubre- Urology

    Madrid, 28041

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, 33011

  • Hospital Universitario Virgen del Rocio- Urología Pediátrica

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Germany5 sites

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • University Hospital Jena KöR

    Jena

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Studienpraxis Urologie

    Nürtingen, 72622

  • Universität Tuebingen - Urology

    Tübingen

Other trials in Germany

Belgium4 sites

  • Cliniques Universitaires Saint-Luc

    Brussels

  • UZ Antwerpen

    Edegem

  • AZGroeninge

    Kortrijk, 8500

  • CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie

    Liège

Other trials in Belgium

Lithuania4 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas

    Kaunas

  • Klaipeda University Hospital

    Klaipėda, LT92288

  • National Cancer Institute

    Vilnius, LT-08660

  • Vilniaus Universiteto ligonines Santariskiu Klinikos

    Vilnius

Other trials in Lithuania

Netherlands4 sites

  • The Netherlands Cancer Institute - Oncology

    Amsterdam

  • Catharina Ziekenhuis - Urology

    Eindhoven, 5623 EJ

  • CWZ

    Nijmegen, 6532 SZ

  • Haga Ziekenhuis

    The Hague

Other trials in Netherlands

Czechia3 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno

  • Fakultni nemocnice Olomouc

    Olomouc

  • Vseobecna Fakultni Nemocnice V Praze

    Prague

Other trials in Czechia

About this study

Official title: An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 6-month Formulation Administered Subcutaneously in Participants With Locally Advanced and/or Metastatic Prostate Cancer Previously Treated and Castrated With a GnRH Analogue

The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.

Conditions
Prostate Cancer
Being tested
Triptorelin embonate 22.5 mg
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triptorelin embonate 22.5 mgDrug

    Also called Decapeptyl

    A prolonged release formulation of triptorelin pamoate 22.5 mg 6-month formulation in D, L-lactide-co-glycolide polymers for single subcutaneous injection on Day 1 and Day 169

Study groups in NCT05458856
Study groupRoleWhat they receive
Triptorelin embonateExperimentalAll participants will receive triptorelin embonate 22.5 mg
Receives: Drug: Triptorelin embonate 22.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Maintenance of castration during the study was defined as testosterone <1.735 nanomoles per liter (nmol/L) (<50 nanograms/deciliter [ng/dL]) at Days 29, 85, 141, 169, 253, 309 and 337.

    Measured: Up to Day 337

Secondary outcomes (6)

  1. Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone <1.735 nmol/L (<50 ng/dL).

    Measured: Days 29, 85, 141, 169, 253, 309 and 337

  2. Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.

    Measured: Up to Day 337

  3. Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.

    Measured: Days 29, 85, 141, 169, 253, 309 and 337

  4. Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone <1.735 nmol/L (<50 ng/dL).

    Measured: On Days 3, 7, 171, and 175

  5. Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337

    Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of the difference between the PSA values at Days 169 and 337 and the baseline value divided by the baseline value. The baseline value was the last sample prior to the first injection.

    Measured: Baseline (prior to injection on Day 1), Days 169 and 337

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance

    An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs were AEs that started or worsened on or after the first study treatment administration and within 168 days after the last dose of study treatment, or up to Day 337, whichever was later. Local tolerance was assessed 2 hours after each injection by examination of injection site for signs such as but not limited to tenderness, redness, bruising, erythema, swelling, rash, pain, itching, induration, hematoma, ulceration or necrosis.

    Measured: From first dose of study treatment (Day 1) up to end of study visit (Day 337)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2022
  2. Study start30 Aug 2022
  3. Primary completion8 Jul 2024
  4. Study completion8 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05458856
Sponsor's protocol ID
D-FR-52014-245
Other IDs
2021-005719-29
Acronym
TriptoSwitch
Status last verified
Jul 2025
First submitted
17 Jun 2022
Last updated
25 Jul 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptorelin embonate 22.5 mg in people with Prostate Cancer, run by Ipsen at 39 sites in 7 countries.

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 15 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in France, Spain, Germany, Belgium, Lithuania and 2 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Who Maintained Castrate Levels of Serum Testosterone During the Study (time frame: Up to Day 337). 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 NCT05458856.

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 25 Jul 2025.

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