Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Locally Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triptorelin pamoate (embonate) salt | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Triptorelin pamoate 22.5 mg 6-month formulation
- description
- All enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.
- interventionNames
- Drug: Triptorelin pamoate (embonate) salt
Primary outcomes (2)
- measure
- Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29
- timeFrame
- Day 29
- 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.
- measure
- Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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