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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT05590793 (opens ClinicalTrials.gov in a new tab)Other idD-CN-52014-237Other idCTR20221796
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
195 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
17 Nov 2022
Primary completion
20 Aug 2024
Completion
20 Aug 2024
First posted
21 Oct 2022
Last update posted
9 Sept 2025
Conditions
Advanced Prostate Cancer · Metastatic Prostate Cancer · Locally Advanced Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 3

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

    NCT05590793

    17 Nov 2022 to 20 Aug 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin pamoate (embonate) saltDrug

Arms1

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29

    Time frame · Day 29

    Registry description

    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.

  2. Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24

    Time frame · From Week 8 to Week 24

    Registry description

    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.

Secondary outcomes(11)

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance

    Time frame · From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days

    Registry description

    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.

  2. Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24

    Time frame · Baseline (Day 1), Weeks 12 and 24

    Registry description

    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.

  3. Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate

    Time frame · 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

    Registry description

    Blood samples were collected at specified timepoints for the assessment of tmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

  4. Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate

    Time frame · 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

    Registry description

    Blood samples were collected at specified timepoints for the assessment of Cmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

  5. Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate

    Time frame · 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

    Registry description

    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.

  6. Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate

    Time frame · 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

    Registry description

    Blood samples were collected at specified timepoints for the assessment of AUClast of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

  7. Time to Maximum Observed Plasma Concentration of Testosterone

    Time frame · Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

    Registry description

    Blood samples were collected at specified timepoints for the assessment of tmax of testosterone. The PD parameters were performed using non-compartmental analysis.

  8. Maximum Observed Plasma Concentration of Testosterone

    Time frame · Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

    Registry description

    Blood samples were collected at specified timepoints for the assessment of Cmax of testosterone. The PD parameters were performed using non-compartmental analysis.

  9. Time to Castration of Testosterone

    Time frame · Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

    Registry description

    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.

  10. Plasma Concentrations of Triptorelin Pamoate

    Time frame · Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24

    Registry description

    Blood samples were collected at specified timepoints for the assessment of plasma concentration of triptorelin pamoate.

  11. Serum Concentrations of Testosterone

    Time frame · Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24

    Registry description

    Blood samples were collected at specified timepoints for the assessment of serum concentration of testosterone.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 29

Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29

GroupValue (percentage of participants)
Triptorelin Pamoate99.5
Primary outcomeNumber· From Week 8 to Week 24

Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24

GroupValue (percentage of participants)
Triptorelin Pamoate100
Secondary and other outcome results(6)
Secondary outcomeCount of participants· From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance

GroupValue (Participants)
Triptorelin Pamoate160
Secondary outcomeMean· Baseline (Day 1), Weeks 12 and 24

Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24

GroupValue (percent change)Spread
Triptorelin Pamoate-90.681510.8057
Secondary outcomeMedian· 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 (Tmax) of Triptorelin Pamoate

GroupValue (hour)
Triptorelin Pamoate2.95
Secondary outcomeMean· 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

GroupValue (ng/milliliter (mL))Spread
Triptorelin Pamoate44.517.5
Secondary outcomeMean· 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

GroupValue (ng*day/mL)Spread
Triptorelin Pamoate51.722.9
Secondary outcomeMean· 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

GroupValue (ng*day/mL)Spread
Triptorelin Pamoate46.322.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Triptorelin PamoateParticipants received a single dose of triptorelin pamoate 22.5 mg IM injection on Day 1.0 / 1958 / 19590 / 195

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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