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 .

• Conditions: advanced prostate cancer (locally advanced or metastatic); MedDRA version: 15.1Level: PTClassification code 10060862Term: Prostate cancerSystem 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]

• Registration Number: EUCTR2010-019632-12-DE
• Lead Sponsor: IPSEN Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-23
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified