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

Metastatic Prostate Cancer Clinical Trial

Official title:

A Multicentre, Open-label, Single-arm Study to Investigate the Efficacy and Safety of Triptorelin Pamoate 22.5 mg 6-month Formulation in Chinese Patients With Locally Advanced or Metastatic Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05590793
• Other study ID #: D-CN-52014-237
• Secondary ID: CTR20221796
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 17, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 195
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• Participant is capable of giving signed informed consent

• Participant must be over 18 years of age, at the time of signing the informed consent.

• Has a histologically or cytologically confirmed adenocarcinoma, locally advanced or metastatic prostate cancer. Or participant has PSA recurrence after curative treatment and be a candidate for androgen deprivation therapy (ADT).

• Has serum testosterone level >150 ng/dL (> 5.2 nmol/L).

• Has expected survival time =12 months according to the investigator's assessment.

• Has Eastern Cooperative Oncology Group (ECOG) performance status score =1

Exclusion Criteria :

• Risk of a serious complication in the case of tumour flare

• Presence of another neoplastic lesion or brain metastases.

• 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 as per Pharmacovigilance Risk Assessment Committee (PRAC) recommendations.

• Metastatic hormone-sensitive prostate cancer with high tumour burden.

• Metastatic castration-resistant prostate cancer.

• Previous surgical castration.

• Previous hormone therapy (including abiraterone) for prostate cancer within 6 months prior to study start.

• Previous cytotoxic chemotherapy treatment within 6 months prior to study start.

• Use of finasteride or dutasteride within 2 months prior to study start

• Previous hypophysectomy or adrenalectomy

• Any current use or use within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and antiandrogens.

• Systemic or inhaled corticosteroids (topical application permitted).

• Any previous use of traditional Chinese medicine or herbal products within 1 month prior to study screening or planned use during the study of products, which are known to have cytotoxic effect or affect the metabolism and/or secretion of androgenic hormones

• Participation in another study with an investigational drug or treatment within 3 months prior to study entry or within 5 drug half-lives of the investigational drug (whichever is the longer).

• Severe kidney or liver impairment (creatinine >2 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >3 x ULN).

• Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance, the i.m. administration of the drug or with the study in the opinion of the investigator.

• 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.

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Locally Advanced Prostate Cancer
• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Triptorelin pamoate (embonate) salt
Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.

Locations

Country	Name	City	State
China	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	Guizhou Provincial People's Hospital	Guiyang
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	Nanjing Drum Tower Hospital	Nanjing
China	Zhongda Hospital Southeast University	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	Liaoning Cancer Hospital & Institute	Shenyang
China	The First Hospital of China Medical University	Shenyang
China	Peking University Shenzhen Hospital	Shenzhen
China	Suining Central Hospital	Suining
China	The Second Affiliated Hospital of Soochow University	Suzhou
China	Tianjin Cancer Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	The First Affiliated Hospital of Wannan Medical College	Wuhu
China	The Second Affiliated Hospital of Wannan Medical College	Wuhu
China	Wuxi People's Hospital	Wuxi
China	Northern Jiangsu People's Hospital	Yangzhou
China	Subei People's Hospital	Yangzhou
China	Yantai Yuhuangding Hospital	Yantai
China	Henan Cancer Hospital	Zhengzhou
China	Zigong First People's Hospital	Zigong

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving castrate levels of serum testosterone (<50 ng/dL or 1.735 nmol/L)		Day 29
Primary	Percentage of participants maintaining the castrate levels		From Week 8 to Week 24
Secondary	Incidence of treatment emergent adverse event (TEAEs) (including local tolerability)		From baseline up to Week 24
Secondary	Actual values and changes from baseline in clinical laboratory tests	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.	At Week 24
Secondary	Actual values and changes from baseline in physical examination	Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.	At Day 1, Week 12 and Week 24
Secondary	Percentages of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings	Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.	At Week 4 and Week 24
Secondary	Change from baseline in vital signs measurements	Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.	At each visit up to Week 24
Secondary	Percent change in prostate specific antigen (PSA) from baseline (prior to injection)	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	At Week 12 and Week 24
Secondary	Pharmacokinetics (PK) of Triptorelin: Time to Maximum Observed Drug Concentration (Tmax)	Tmax will be recorded from the PK blood samples collected.	Up to 24 weeks
Secondary	PK of Triptorelin: Maximum Observed Plasma (peak) Drug Concentration (Cmax)	Cmax will be recorded from the PK blood samples collected.	Up to 24 weeks
Secondary	PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Visit on Day 169 (AUC0-169)	AUC0-169 will be recorded from the PK blood samples collected.	up to Day 169
Secondary	PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Last Quantifiable Concentration (AUClast)	AUClast will be recorded from the PK blood samples collected.	Up to 24 weeks
Secondary	Pharmacodynamics (PD) of Testosterone: Maximum Observed Plasma (peak) Drug Concentration (Cmax)	Cmax will be recorded from the PD blood samples collected.	Up to 24 weeks
Secondary	PD of Testosterone: Time to Maximum Observed Drug Concentration (Tmax)	Tmax will be recorded from the PD blood samples collected.	Up to 24 weeks
Secondary	PD of Testosterone: Time to Castration(Tcast)	Tcast will be recorded from the PD blood samples collected.	Up to 24 weeks
Secondary	Sparse plasma concentrations of triptorelin		At pre-dose and at Week 4, 8, 12, 16, 20 and 24
Secondary	Sparse serum concentrations of testosterone		At pre-dose and at Week 4, 8, 12, 16, 20 and 24