Status:
COMPLETED
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-and...
Eligibility Criteria
Inclusion
- Patient has given written informed consent
- Patient is 18 years or older
- Patient has histologically confirmed prostate cancer
- Patient has a serum prostate-specific antigen (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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00884273
Start Date
August 1 2009
End Date
March 1 2011
Last Update
November 13 2013
Active Locations (46)
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1
Hospital St Jan Brugge
Bruges, Belgium
2
Institut Jules Bordet
Brussels, Belgium
3
University Hospitals Leuven
Leuven, Belgium
4
St. Elisabethziekenhuis
Turnhout, Belgium