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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Triptorelin embonate 22.5 mg

• Registration Number: NCT05458856
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-14
• Study Start: 2022-08-30
• Primary Completion: 2024-07-08
• Study Completion: 2024-07-08
• Status Verified: 2025-07
• Results First Submitted: 2025-07-04
• Results First Submitted QC: 2025-07-04
• Results First Posted: 2025-07-23
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 147

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triptorelin embonate	Triptorelin embonate 22.5 mg	All participants will receive triptorelin embonate 22.5 mg

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study	Up to Day 337	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337	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).
Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study	Up to Day 337	Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.
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	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.
Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169	On Days 3, 7, 171, and 175	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).
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337	Baseline (prior to injection on Day 1), 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance	From first dose of study treatment (Day 1) up to end of study visit (Day 337)	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.

Trial Locations

Locations (39)

CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie; 🇧🇪 Liège, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

AZGroeninge; 🇧🇪 Kortrijk, Belgium

Fakultni nemocnice u sv. Anny v Brne; 🇨🇿 Brno, Czechia

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

Vseobecna Fakultni Nemocnice V Praze; 🇨🇿 Praha, Czechia

Centre Hospitalier Universitaire D'Angers - Urologie; 🇫🇷 Angers, France

CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat; 🇫🇷 Brest, France

Clinique Pasteur-Lanroze - Oncology; 🇫🇷 Brest, France

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