prostate cancer MedDRA version: 24.1 Level: LLT Classification code 10085679 Term: Locally advanced prostate cancer System Organ Class: 100000004864
Conditions
Sponsors
Ipsen Pharma SAS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Participant is male and must be 18 years of age inclusive, at the time of signing the informed consent. 2. Participant has histologically or cytologically proven prostate cancer with rising PSA after failed local therapy or metastatic disease, or requiring radiotherapy, and be a candidate for long-term (i.e. >1 year) androgen deprivation therapy. 3. Participant requires a GnRH analogue treatment for a minimum of 18 months, of which a minimum of 3 months of GnRH analogue treatment has already been provided prior to screening. (Note: participants must receive study intervention on Day 1 in accordance with the treatment schedule of their previously received GnRH analogue therapy). 4. Has serum testosterone levels 18 months. 7. Male participants must agree that, if their partner is at risk of becoming pregnant (although highly unlikely in this study population), they will use an effective method of contraception. The participant must agree to use the contraception during the whole of the study and for 9 months after the last dose of study intervention. 8. Capable of giving signed informed consent as described in Appendix 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 31 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 122
Exclusion criteria
Exclusion criteria: Medical conditions 1.Presence of another neoplastic lesion or brain metastases. 2.Metastatic hormone-sensitive prostate cancer with high tumour burden 3.Metastatic castration-resistant prostate cancer 4.Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance or with the study in the opinion of the investigator. Prior/concomitant therapy 5.Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the past 6 months 6.Planned intermittent scheme of GnRH analogue 7.Use of any other therapy for prostate cancer during the study (e.g. chemotherapy) 8.Prior hypophysectomy or adrenalectomy Prior/concurrent clinical study experience 9.Participation in another study with an experimental drug within 3 months before signing informed consent or within five half-lives of the investigational drug (whichever was the longer), or any other type of medical research. Diagnostic assessments 10.Severe kidney or liver failure (creatinine >2 times the normal range, aspartate aminotransferase and alanine aminotransferase >3 times the normal range) Other exclusions 11.Any concomitant disorder or resulting therapy that is likely to interfere with participant’s compliance, the subcutaneous administration of the drug or with the study in the opinion of the investigator. 12.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 13.Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues. 14.Known active use of recreational drug or alcohol dependence in the opinion of the investigator 15.Inability to give informed consent or to comply fully with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously in maintaining serum testosterone castrate levels in participants with advanced prostate cancer previously treated and castrated with a GnRH analogue. ;Secondary Objective: - To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously on castration; - To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously on testosterone levels <0.694 nmol/L (20 ng/dL); - To demonstrate the effect of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously to suppress the ‘acute-on-chronic’ effect following the administration of the second dose; - To demonstrate the effect of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously in the maintenance of PSA; - To demonstrate the safety profile of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously; ;Primary end point(s): Percentage of participants maintaining castrate levels of serum testosterone during the study (maintenance of castration defined as testosterone <1.735 nmol/L (50 ng/dL) at Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337);Timepoint(s) of evaluation of this end point: Please refer to E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of participants castrated at each timepoint on Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337 (castration defined as testosterone <1.735 nmol/L (50 ng/dL)). - Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL) during the study. - Percentage of participants with a serum testosterone level <0.69 nmol/L (20 ng/dL) at each timepoint on Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337. - Percentage of participants castrated on Day 3 and Day 7 after each injection administered on Day 1 and Day 169 (castration defined as testosterone <1.735 nmol/L (50 ng/dL)). - Percent change in PSA from baseline (prior to injection) at Day 169 and Day 337 (Percent change in PSA defined as the absolute value of difference between the PSA values at Day 169 and Day 337 and the baseline value divided by the baseline value). - Incidence of TEAEs (including local tolerability) throughout the study i.e. up to Day 337. - Change from baseline in clinical safety laboratory parameters (blood chemistry and haematology) at Day 337 - Change from baseline in physical examination at Day 169 and Day 337 - Change from baseline in ECG at Day 337 - Change from baseline in vital signs (blood pressure and heart rate) at each visit up to Day 337;Timepoint(s) of evaluation of this end point: Please refer to E.5.2 | — |
Countries
Czech Republic, France, Lithuania, Netherlands, Spain
Contacts
Public ContactMedical Monitor
Ipsen Bioinnovation
Outcome results
None listed