Clinical trial NCT05590793: Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Prostate Cancer
Metastatic Prostate Cancer
Locally Advanced Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2022-10-21
Enrollment: 195
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.
* 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 screening.
* Use of finasteride or dutasteride within 2 months prior to study screening.
* 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.
* Current use of 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 screening 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.

Primary outcomes:
measure: Percentage of participants achieving castrate levels of serum testosterone (<50 ng/dL or 1.735 nmol/L)
timeFrame: Day 29
measure: Percentage of participants maintaining the castrate levels
timeFrame: From Week 8 to Week 24
Secondary outcomes:
measure: Incidence of treatment emergent adverse event (TEAEs) (including local tolerability)
timeFrame: From baseline up to Week 24
measure: Actual values and changes from baseline in clinical laboratory tests
timeFrame: At Week 24
measure: Actual values and changes from baseline in physical examination
timeFrame: At Day 1, Week 12 and Week 24
measure: Percentages of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings
timeFrame: At Week 4 and Week 24
measure: Change from baseline in vital signs measurements
timeFrame: At each visit up to Week 24
measure: Percent change in prostate specific antigen (PSA) from baseline (prior to injection)
timeFrame: At Week 12 and Week 24
measure: Pharmacokinetics (PK) of Triptorelin: Time to Maximum Observed Drug Concentration (Tmax)
timeFrame: Up to 24 weeks
measure: PK of Triptorelin: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
timeFrame: Up to 24 weeks
measure: PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Visit on Day 169 (AUC0-169)
timeFrame: up to Day 169
measure: PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Last Quantifiable Concentration (AUClast)
timeFrame: Up to 24 weeks
measure: Pharmacodynamics (PD) of Testosterone: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
timeFrame: Up to 24 weeks
measure: PD of Testosterone: Time to Maximum Observed Drug Concentration (Tmax)
timeFrame: Up to 24 weeks
measure: PD of Testosterone: Time to Castration(Tcast)
timeFrame: Up to 24 weeks
measure: Sparse plasma concentrations of triptorelin
timeFrame: At pre-dose and at Week 4, 8, 12, 16, 20 and 24
measure: Sparse serum concentrations of testosterone
timeFrame: At pre-dose and at Week 4, 8, 12, 16, 20 and 24
Other outcomes:
Locations:
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Deyang
country: China
facility: Deyang People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Ningbo
country: China
facility: Ningbo First Hospital
city: Shanghai
country: China
facility: Fudan University Shang Hai Cancer Center
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Suining
country: China
facility: Suining Central Hospital
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
city: Wuhu
country: China
facility: The Second Affiliated Hospital of Wannan Medical College
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
city: Yangzhou
country: China
facility: Subei People's Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zigong
country: China
facility: Zigong First People's Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical, Director
role: STUDY_DIRECTOR
References: