Clinical trial NCT01715129: Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer
Official title: A Phase III Single Arm Study to Evaluate the Efficacy, Safety and Local Tolerability of a Subcutaneous 3-month Formulation of Triptorelin Pamoate (11.25 mg) in Patients With Locally Advanced or Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 126
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.


Eligibility criteria: Inclusion Criteria:

* Histologically proven locally advanced or metastatic prostate cancer who are suitable for androgen deprivation therapy
* Male aged ≥18 years old
* Screening testosterone level of \>125 ng/dL
* Life expectancy of greater than 12 months in the judgement of the Investigator
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Willing to give signed informed consent freely
* Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* Prior hormonal therapy for prostate cancer
* Prior surgery or radiotherapy of prostate cancer with curative intent unless disease is verified by a rising prostate specific antigen (PSA) concentration on follow up (elevated PSA values on last two tests conducted at least a month apart) and the patient is eligible for androgen deprivation therapy
* Presence or history of any other malignancy except for non melanoma skin cancer adequately treated at least 2 years before study entry
* Painful local bone lesions or spinal lesions which may lead to compression
* History of myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, Class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within six months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and untreated atrial or uncontrolled ventricular arrhythmias
* Any condition in opinion of the Investigator, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study, compromises the objective of the study or places the patient at unacceptable risk if he participates in the study
* Abnormal haematological, hepatic or renal functions:

  * Haemoglobin \<9 g/dL, absolute neutrophil count ≤1.5 x 10\^9/L or platelets ≤100 x 10\^9/L
  * Serum creatinine ≥1.5 times the upper limit of normal (ULN)
  * Aspartate aminotransferase or alanine aminotransferase \>2.5 times the ULN
* Known hypersensitivity to the study treatment, to any of its excipients
* Known active use of recreational drug or alcohol dependence in the opinion of the Investigator
* Any current use or use within six months prior to start of treatment, of medications which are known to affect the metabolism and/or secretion of androgenic hormones: e.g. ketoconazole, aminoglutethimide, oestrogens, and progesterone
* Use of systemic corticosteroids (inhaled corticosteroids and topical application of corticosteroids are permitted)
* Aged ≥90 years for the main study and ≥80 years for those included in the pharmacokinetic (PK) patient population
* Participation in any other study or receipt of any investigational compound in the 30 days (or five times the elimination half life if this is longer) prior to study entry
* Any skin or other condition that may preclude s.c. injection administration
* Known brain or epidural metastases.

Primary outcomes:
measure: Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183
timeFrame: At Day 29 and 183
Secondary outcomes:
measure: Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose
timeFrame: At Day 92
measure: Probability of Testosterone <50 ng/dL
timeFrame: Day 29 through Day 183
measure: Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95
timeFrame: Day 95
measure: Time to Achieve Castration (Tcast)
timeFrame: Up to Day 36
measure: Plasma Triptorelin Levels (Cmin)
timeFrame: At Day 92 and 183
measure: Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects
timeFrame: From Day 1 (Baseline) to Day 183 (End of study)
measure: Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)
timeFrame: At Day 183
measure: Clinically Apparent Tumor Progression
timeFrame: Day 92 and 183
measure: Percentage of Subjects With Adverse Events
timeFrame: Up to Day 183
measure: Time to Cmax (Tmax) of Triptorelin
timeFrame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1
measure: Peak Plasma Concentration Value (Cmax) of Triptorelin
timeFrame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1
measure: Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin
timeFrame: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1
measure: Cmin of Triptorelin in Subset of 18 Subjects
timeFrame: At Day 92 and 183
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Shumen
country: Bulgaria
city: Varna
country: Bulgaria
city: Suresnes
country: France
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Kutno
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Craiova
country: Romania
Study officials:
affiliation: Ipsen
name: Medical Director, Uro-Oncology
role: STUDY_DIRECTOR
References: