The study investigates the new subcutaneous application of Triptorelin pamoate (Pamorelin® LA 11.25 mg) versus the intramuscular application in patients with advanced prostate cancer .

• Register: EUCTR
• Last refreshed on: 1 April 2013
• Main ID: EUCTR2010-019632-12-DE
• Date of registration: 23/08/2010
• Prospective Registration: Yes
• Primary sponsor: IPSEN Pharma GmbH
• Public title: The study investigates the new subcutaneous application of Triptorelin pamoate (Pamorelin® LA 11.25 mg) versus the intramuscular application in patients with advanced prostate cancer .
• Scientific title: A phase II, multicentre, open, prospective, randomised, parallel-group, pharmacodynamic equivalence study on intramuscular versus subcutaneous applications of Triptorelin pamoate (Pamorelin® LA 11.25 mg) in patients with advanced prostate cancer - PAMIS
• Date of first enrolment: 19/10/2010
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019632-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany

Contacts

• Name: Dr. Andrea Röthler
• Affiliation: GKM Gesellschaft für Therapieforschung mbH

• Name: Dr. Andrea Röthler
• Affiliation: GKM Gesellschaft für Therapieforschung mbH

Key inclusion & exclusion 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:
(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


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

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)

Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Intervention(s)

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(s)
Concentration type: equal
Concentration number: 11.25 -

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(s)
Concentration type: equal
Concentration number: 11.25-

Primary Outcome(s)

Primary end point(s): Area under the curve of testosterone serum concentration between D1 and D85 [AUC1-85d].

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

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.

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 Outcome(s)

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

Secondary ID(s)

A-94-5214-178

Source(s) of Monetary Support

IPSEN Pharma GmbH