advanced prostate cancer (locally advanced or metastatic) MedDRA version: 15.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Pamorelin LA 11.25 mg
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: TRIPTORELINPAMOATE
CAS Number: 57773-63-4
Concentration unit: mg milligram(
Sponsors
IPSEN Pharma GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Provision of written informed consent prior to any study related procedures. (2) Male patients aged 18 years and older (3) Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA after failed local therapy, and the patient scheduled to receive androgen deprivation therapy - Definition of locally advanced: T3 or T4 or N1 with any T, M09 - Definition of metastatic: any T, any N, M1 (4) Serum testosterone levels = 125 ng/dl (1.25 ng/ml, 1.25 ng/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start (5) Karnofsky performance index > 70 (6) Expected survival = 9 months (7) Absence of other malignancy, other than dermatological, for the previous 5 years Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: (1) Prior hormonal treatment for prostate cancer including finasteride, oestrogens or a steroidal anti–androgen within the last 6 months preceding the study or concomitant treatment with one or more of these substance(s) (2) Prior hormonal treatment for prostate cancer including GnRH agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s) (3) Presence of another malignant neoplasm (4) Prior hypophysectomy or adrenalectomy (5) Patient who is scheduled to receive an orchiectomy during the course of this study (6) Any current use or 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 progesterone (7) Use of corticosteroids, except topical applications (8) Patient at risk of spinal cord compression or ureter obstruction (9) Patient with abnormal baseline findings or any other medical condition(s) that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study (10) Patient has a history of hypersensitivity to the IMP or drugs with a similar chemical structure (11) Inability to give informed consent or to comply fully with the protocol (12) Participation in another clinical trial within the last 30 days or simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85d] for serum testosterone in patients with advanced prostate cancer.;Secondary Objective: Secondary objectives are: • Time to castration [tcast] in patients with advanced prostate cancer • Area under the curve [AUC1-169d] for testosterone • Area under the curve [AUC85-169d] for testosterone • Maximum concentration of serum testosterone [Cmax] • Time to maximum concentration of serum testosterone [tmax] • Number and percentage of patients attaining castrate level by day 29 and maintaining castration until the end of the second dosing interval without showing relevant escapes from castration • Percentage of patients with castration levels of testosterone • Course of PSA and testosterone levels and changes from baseline • Evaluate the Visual Analogue Scale (VAS) for tumour-related pain, e.g. bone pain • Safety profiles of IM and SC injections of triptorelin pamoate 11.25 mg ;Primary end point(s): Area under the curve of testosterone serum concentration between D1 and D85 [AUC1-85d].;Timepoint(s) of evaluation of this end point: Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day, Day 57, Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Area under the curve [AUC85-169d] for testosterone;Timepoint(s) of evaluation of this end point: Day 85, Day 87, Day 113, Day 141, Day 169 | — |
Countries
Germany
Contacts
Public ContactDr. Andrea Röthler
GKM Gesellschaft für Therapieforschung mbH
Outcome results
None listed