Phase 3
Completed N=195
Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
Advanced Prostate Cancer · Metastatic Prostate Cancer · Locally Recurrent Prostate Cancer
Source: ClinicalTrials.gov NCT05590793 ↗
Enrolled (actual)
195
Serious AEs
4.1%
Results posted
Sep 2025
Primary outcomePrimary: Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29 — 99.5 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29 |
99.5 | — |
| PRIMARY Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24 |
100 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance |
160; 8; 7 | — |
| SECONDARY Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24 |
-90.6815; -92.1673 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate |
2.95 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate |
44.5 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate |
51.7 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate |
46.3 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration of Testosterone |
2.00 | — |
| SECONDARY Maximum Observed Plasma Concentration of Testosterone |
21.9 | — |
| SECONDARY Time to Castration of Testosterone |
19.3 | — |
| SECONDARY Plasma Concentrations of Triptorelin Pamoate |
NA; 0.0743; 0.1236; 0.0602; 0.1555; 0.0607 | — |
| SECONDARY Serum Concentrations of Testosterone |
17.0506; 0.5602; 0.3294; 0.3281; 0.3334; 0.3404 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05590793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.