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.

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.