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

Ipsen

Status and phase

Completed

Phase 3

Conditions

Metastatic Prostate Cancer

Advanced Prostate Cancer

Locally Advanced Prostate Cancer

Treatments

Drug: Triptorelin pamoate (embonate) salt

Study type

Interventional

Funder types

Industry

Identifiers

NCT05590793

CTR20221796 (Registry Identifier)

D-CN-52014-237

Details and patient eligibility

About

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.

Enrollment

195 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.