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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Prostate Cancer; Advanced Prostate Cancer; Locally Advanced Prostate Cancer
• Intervention / Treatment: Drug: Triptorelin pamoate (embonate) salt

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Baoding, China
    • Affiliated Hospital of Hebei University
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Beijing Hospital
  • Beijing, China
    • Peking University People's Hospital
  • Changsha, China
    • Hunan Cancer Hospital
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University
  • Chongqing, China
    • Chongqing University Cancer Hospital
  • Deyang, China
    • Deyang People's Hospital
  • Guangzhou, China
    • Sun Yat-sen University Cancer Center
  • Guiyang, China
    • The Affiliated Hospital of Guizhou Medical University
  • Guiyang, China
    • Guizhou Provincial People's Hospital
  • Hangzhou, China
    • The first Affiliated Hospital, Zhejiang University School of Medicine
  • Jinan, China
    • Shandong Provincial Hospital
  • Jinan, China
    • Qilu Hospital of Shandong University
  • Nanjing, China
    • Nanjing Drum Tower Hospital
  • Nanjing, China
    • Zhongda Hospital Southeast University
  • Ningbo, China
    • Ningbo First Hospital
  • Shanghai, China
    • Shanghai Fifth People's Hospital
  • Shanghai, China
    • Shanghai Tongji Hospital
  • Shanghai, China
    • Fudan University Shang Hai Cancer Center
  • Shenyang, China
    • The First Hospital of China Medical University
  • Shenyang, China
    • Liaoning Cancer Hospital & Institute
  • Shenzhen, China
    • Peking University Shenzhen Hospital
  • Suining, China
    • Suining Central Hospital
  • Suzhou, China
    • The Second Affiliated Hospital of Soochow University
  • Tianjin, China
    • Tianjin Cancer Hospital
  • Wenzhou, China
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhu, China
    • The First Affiliated Hospital of Wannan Medical College
  • Wuhu, China
    • The Second Affiliated Hospital of Wannan Medical College
  • Wuxi, China
    • Wuxi People's Hospital
  • Yangzhou, China
    • Northern Jiangsu People's Hospital
  • Yangzhou, China
    • Subei People's Hospital
  • Yantai, China
    • Yantai Yuhuangding Hospital
  • Zhengzhou, China
    • Henan Cancer Hospital
  • Zigong, China
    • Zigong First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Triptorelin pamoate (embonate) salt; Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.; Other Names: Dipherelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, or any other medically important event. TEAEs were AEs with start date on or after the date of study intervention administration and up to 24 weeks after date of first dose of treatment. Local tolerance was assessed 2 hours (+/-15 minutes) after the single injection of 6-month formulation triptorelin by examination of injection site for signs including but not limited to tenderness, erythema, swelling, hematoma, rash, pain, itching and induration.	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	Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of difference between the PSA values at Week 12 and Week 24 and the baseline value divided by the baseline value. Baseline was defined as the last non-missing measurement taken prior to first study intervention administration.	Baseline (Day 1), Weeks 12 and 24
Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate	Blood samples were collected at specified timepoints for the assessment of tmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.	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	Blood samples were collected at specified timepoints for the assessment of Cmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.	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	Blood samples were collected at specified timepoints for the assessment of AUC0-169 of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.	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 Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate	Blood samples were collected at specified timepoints for the assessment of AUClast of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.	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
Time to Maximum Observed Plasma Concentration of Testosterone	Blood samples were collected at specified timepoints for the assessment of tmax of testosterone. The PD parameters were performed using non-compartmental analysis.	Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169
Maximum Observed Plasma Concentration of Testosterone	Blood samples were collected at specified timepoints for the assessment of Cmax of testosterone. The PD parameters were performed using non-compartmental analysis.	Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169
Time to Castration of Testosterone	Blood samples were collected at specified timepoints for the assessment of tcast of testosterone. tcast was defined as time to reach serum testosterone level <50 ng/dL or 1.735 nmol/L. The PD parameters were performed using non-compartmental analysis.	Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169
Plasma Concentrations of Triptorelin Pamoate	Blood samples were collected at specified timepoints for the assessment of plasma concentration of triptorelin pamoate.	Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24
Serum Concentrations of Testosterone	Blood samples were collected at specified timepoints for the assessment of serum concentration of testosterone.	Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical, Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Inorganic Chemicals; Gonadotropin-Releasing Hormone; Triptorelin Pamoate; Salts
• Other Study ID Numbers: D-CN-52014-237; CTR20221796 (Registry Identifier: ChinaDrugTrial.org)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No