Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
NCT ID: NCT05590793
Last Updated: 2025-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
195 participants
INTERVENTIONAL
2022-11-17
2024-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Triptorelin pamoate 22.5 mg 6-month formulation
All enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.
Triptorelin pamoate (embonate) salt
Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.
Interventions
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Triptorelin pamoate (embonate) salt
Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical, Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTR20221796
Identifier Type: REGISTRY
Identifier Source: secondary_id
D-CN-52014-237
Identifier Type: -
Identifier Source: org_study_id
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