Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
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
2 other identifiers
interventional
195
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2022
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedStudy Start
First participant enrolled
November 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2024
CompletedResults Posted
Study results publicly available
September 9, 2025
CompletedSeptember 9, 2025
August 1, 2025
1.8 years
October 14, 2022
August 18, 2025
August 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on 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.
Day 29
Percentage of Participants Who Maintained the Castrate Levels 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.
From Week 8 to Week 24
Secondary Outcomes (11)
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
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24
Baseline (Day 1), Weeks 12 and 24
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
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
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
- +6 more secondary outcomes
Study Arms (1)
Triptorelin pamoate 22.5 mg 6-month formulation
EXPERIMENTALAll enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.
Interventions
Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical, Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2022
First Posted
October 21, 2022
Study Start
November 17, 2022
Primary Completion
August 20, 2024
Study Completion
August 20, 2024
Last Updated
September 9, 2025
Results First Posted
September 9, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.