Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00884273

Purpose

This is a Phase 3b clinical trial in prostate cancer patients which aims to compare the current standard therapy of a gonadotrophin releasing hormone(GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume.

The hypothesis is that degarelix can decrease prostate size as effectively as the combination of a GnRH agonist with an anti-androgen flare protection.

Condition	Intervention	Phase
Prostate Cancer	Drug: degarelix Drug: Goserelin + bicalutamide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin Bicalutamide Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Mean percentage reduction in prostate volume measured with TRUS [ Time Frame: End of trial (12 weeks) compared to baseline. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean percentage reduction in prostate volume [ Time Frame: At 4 and at 8 weeks compared to baseline. ] [ Designated as safety issue: No ]
Lower urinary tract symptom (LUTS) relief based on international prostate symptom score (IPSS) form [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] [ Designated as safety issue: No ]
Change in testosterone based on serum level measurements [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] [ Designated as safety issue: No ]
Mean percentage change in PSA based on serum level measurements [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] [ Designated as safety issue: No ]
Change in Quality of Life evaluation due to urinary symptoms based on the supplementary question on quality of life on the IPSS form [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] [ Designated as safety issue: No ]
Change in burden of urinary symptoms based on the benign prostatic hyperplasia impact index (BPHII) [ Time Frame: At 4, 8, 12 weeks compared to baseline. ] [ Designated as safety issue: No ]
Frequency and severity of adverse events (AEs) and clinically significant change in laboratory value [ Time Frame: During the entire study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	August 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Experimental	Drug: degarelix
2.: Active Comparator	Drug: Goserelin + bicalutamide

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has given written informed consent
Patient is 18 years or older
Patient has histologically confirmed prostate cancer
Patient has a serum PSA level at screening >2 ng/mL
The prostate size is >30 cubic centimetres (cc), measured by TRUS
Patient has had a bone-scan within 12 weeks before inclusion
Patient must be able to undergo transrectal examinations
Patient has an estimated life expectancy of at least 12 months

Exclusion Criteria:

Any previous treatments for prostate cancer
Previous trans-urethral resection of the prostate (TURP)
Is not considered a candidate for medical castration
Use of urethral catheter
Is currently treated with a 5-alpha reductase inhibitor
Is currently treated with an alpha-adrenoceptor antagonist
Treatment with botulinum toxin A (Botox)
Require radiotherapy during the trial
History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
Hypersensitivity towards any component of the investigational products or excipients
Previous history or presence of another malignancy
A clinically significant disorder
A corrected QT interval over 450 msec
Mental incapacity or language barrier precluding adequate understanding or co-operation
Receipt of an investigational drug within the last 28 days proceeding screening
Previous participation in any degarelix trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884273

Contacts

Contact: Clinical Development Support

DK0-Disclosure@ferring.com

Show 42 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE200486 CS31, EudraCT number: 2008-008604-40
Study First Received:	April 17, 2009
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00884273 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Finland: National Agency for Medicines; Norway: Norwegian Medicines Agency; Portugal: National Pharmacy and Medicines Institute; Italy: The Italian Medicines Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Turkey: Ministry of Health

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Goserelin
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms

Genital Diseases, Male
Hormones
Androgen Antagonists
Bicalutamide
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Urogenital Neoplasms

Genital Diseases, Male
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on August 24, 2009