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

• Status: Not yet recruiting
• Trial end date: 2024-05-20
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Triptorelin Pamoate

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 as per Pharmacovigilance Risk Assessment Committee (PRAC) recommendations.

• 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 start.

• Use of finasteride or dutasteride within 2 months prior to study start

• 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.

• 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 entry 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.