Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
- Conditions
- Locally Advanced Prostate CancerAdvanced Prostate CancerMetastatic Prostate Cancer
- Interventions
- 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
Not provided
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 maintaining the castrate levels From Week 8 to Week 24 Percentage of participants achieving castrate levels of serum testosterone (<50 ng/dL or 1.735 nmol/L) Day 29
- Secondary Outcome Measures
Name Time Method PD of Testosterone: Time to Maximum Observed Drug Concentration (Tmax) Up to 24 weeks Tmax will be recorded from the PD blood samples collected.
Actual values and changes from baseline in clinical laboratory tests At Week 24 Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator.
Actual values and changes from baseline in physical examination At Day 1, Week 12 and Week 24 Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.
Percentages of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings At Week 4 and Week 24 Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.
Change from baseline in vital signs measurements At each visit up to Week 24 Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.
Pharmacokinetics (PK) of Triptorelin: Time to Maximum Observed Drug Concentration (Tmax) Up to 24 weeks Tmax will be recorded from the PK blood samples collected.
PK of Triptorelin: Maximum Observed Plasma (peak) Drug Concentration (Cmax) Up to 24 weeks Cmax will be recorded from the PK blood samples collected.
PD of Testosterone: Time to Castration(Tcast) Up to 24 weeks Tcast will be recorded from the PD blood samples collected.
Incidence of treatment emergent adverse event (TEAEs) (including local tolerability) From baseline up to Week 24 Pharmacodynamics (PD) of Testosterone: Maximum Observed Plasma (peak) Drug Concentration (Cmax) Up to 24 weeks Cmax will be recorded from the PD blood samples collected.
Percent change in prostate specific antigen (PSA) from baseline (prior to injection) At Week 12 and Week 24 Percent change in PSA is defined as the absolute value of difference between the PSA values and the baseline value divided by the baseline value
PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Visit on Day 169 (AUC0-169) up to Day 169 AUC0-169 will be recorded from the PK blood samples collected.
PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Last Quantifiable Concentration (AUClast) Up to 24 weeks AUClast will be recorded from the PK blood samples collected.
Sparse plasma concentrations of triptorelin At pre-dose and at Week 4, 8, 12, 16, 20 and 24 Sparse serum concentrations of testosterone At pre-dose and at Week 4, 8, 12, 16, 20 and 24
Trial Locations
- Locations (36)
Beijing Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, China
West China Hospital of Sichuan University
🇨🇳Chengdu, China
Deyang People's Hospital
🇨🇳Deyang, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China
Shandong Provincial Hospital
🇨🇳Jinan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, China
Subei People's Hospital
🇨🇳Yangzhou, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, China
Hunan Cancer Hospital
🇨🇳Changsha, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, China
Wuxi People's Hospital
🇨🇳Wuxi, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
Ningbo First Hospital
🇨🇳Ningbo, China
Fudan University Shang Hai Cancer Center
🇨🇳Shanghai, China
Shanghai Fifth People's Hospital
🇨🇳Shanghai, China
Shanghai Tongji Hospital
🇨🇳Shanghai, China
The First Hospital of China Medical University
🇨🇳Shenyang, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Suining Central Hospital
🇨🇳Suining, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
The Second Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, China
Zigong First People's Hospital
🇨🇳Zigong, China
Peking University First Hospital
🇨🇳Beijing, China