effects of triptorelin pamoate 6-month when given to adult chinese participants with advanced cancer in the prostate

Conditions: Advanced Prostate Cancer; Metastatic Prostate Cancer; Locally Advanced Prostate Cancer

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.


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.