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

Ipsen195 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

195

Conditions

Advanced Prostate Cancer Metastatic Prostate Cancer Locally Advanced Prostate Cancer

Interventions

Triptorelin pamoate (embonate) saltDRUG

Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (36)

Outcomes

Primary Outcomes

Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29

Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Achievement of testosterone castration was defined as serum testosterone level \<50 nanograms per deciliter (ng/dL) or 1.735 nanomoles/liter (nmol/L). Percentages are rounded off to the tenth decimal place.

Time frame: Day 29

Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24

Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive LC-MS/MS method. Maintenance of castration was defined as serum testosterone level \<50 ng/dL or 1.735 nmol/L.

Time frame: From Week 8 to Week 24

Secondary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, or any other medically important event. TEAEs were AEs with start date on or after the date of study intervention administration and up to 24 weeks after date of first dose of treatment. Local tolerance was assessed 2 hours (+/-15 minutes) after the single injection of 6-month formulation triptorelin by examination of injection site for signs including but not limited to tenderness, erythema, swelling, hematoma, rash, pain, itching and induration.

Time frame: From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days

Data from ClinicalTrials.gov

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Affiliated Hospital of Hebei University

Baoding, China

Beijing Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Hunan Cancer Hospital

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Deyang People's Hospital

Deyang, China

Sun Yat-Sen University Cancer Center

Guangzhou, China

...and 26 more locations