Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate

Phase 3

Completed

Conditions: Locally Advanced Prostate Cancer
Advanced Prostate Cancer
Metastatic Prostate Cancer

Interventions: Drug: Triptorelin pamoate (embonate) salt

Registration Number: NCT05590793

Lead Sponsor: Ipsen

Brief Summary: The main aim of this study is to assess the effectiveness and safety of the 6-month formulation of triptorelin pamoate in Chinese participants with locally advanced or metastatic cancer of the prostate. Participants will receive 1 injection of triptorelin pamoate 6-month formulation.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triptorelin pamoate 22.5 mg 6-month formulation	Triptorelin pamoate (embonate) salt	All enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29	Day 29	Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Achievement of testosterone castration was defined as serum testosterone level \<50 nanograms per deciliter (ng/dL) or 1.735 nanomoles/liter (nmol/L). Percentages are rounded off to the tenth decimal place.
Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24	From Week 8 to Week 24	Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive LC-MS/MS method. Maintenance of castration was defined as serum testosterone level \<50 ng/dL or 1.735 nmol/L.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance	From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, or any other medically important event. TEAEs were AEs with start date on or after the date of study intervention administration and up to 24 weeks after date of first dose of treatment. Local tolerance was assessed 2 hours (+/-15 minutes) after the single injection of 6-month formulation triptorelin by examination of injection site for signs including but not limited to tenderness, erythema, swelling, hematoma, rash, pain, itching and induration.
Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate	Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169	Blood samples were collected at specified timepoints for the assessment of tmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.
Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate	Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169	Blood samples were collected at specified timepoints for the assessment of AUC0-169 of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24	Baseline (Day 1), Weeks 12 and 24	Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of difference between the PSA values at Week 12 and Week 24 and the baseline value divided by the baseline value. Baseline was defined as the last non-missing measurement taken prior to first study intervention administration.
Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate	Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169	Blood samples were collected at specified timepoints for the assessment of Cmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate	Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169	Blood samples were collected at specified timepoints for the assessment of AUClast of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.
Time to Maximum Observed Plasma Concentration of Testosterone	Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169	Blood samples were collected at specified timepoints for the assessment of tmax of testosterone. The PD parameters were performed using non-compartmental analysis.
Maximum Observed Plasma Concentration of Testosterone	Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169	Blood samples were collected at specified timepoints for the assessment of Cmax of testosterone. The PD parameters were performed using non-compartmental analysis.
Time to Castration of Testosterone	Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169	Blood samples were collected at specified timepoints for the assessment of tcast of testosterone. tcast was defined as time to reach serum testosterone level \<50 ng/dL or 1.735 nmol/L. The PD parameters were performed using non-compartmental analysis.
Plasma Concentrations of Triptorelin Pamoate	Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24	Blood samples were collected at specified timepoints for the assessment of plasma concentration of triptorelin pamoate.
Serum Concentrations of Testosterone	Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24	Blood samples were collected at specified timepoints for the assessment of serum concentration of testosterone.

Trial Locations

Locations (36): Affiliated Hospital of Hebei University
🇨🇳
Baoding, China
Beijing Hospital
🇨🇳
Beijing, China
Peking University First Hospital
🇨🇳
Beijing, China
Peking University People's Hospital
🇨🇳
Beijing, China
Hunan Cancer Hospital
🇨🇳
Changsha, China
West China Hospital of Sichuan University
🇨🇳
Chengdu, China
Chongqing University Cancer Hospital
🇨🇳
Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳
Chongqing, China
Deyang People's Hospital
🇨🇳
Deyang, China
Sun Yat-Sen University Cancer Center
🇨🇳
Guangzhou, China
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Affiliated Hospital of Hebei University
🇨🇳Baoding, China