Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


Inclusion Criteria:



1. Patient has given written informed consent

2. Patient is 18 years or older

3. Patient has histologically confirmed prostate cancer

4. Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL

5. The prostate size is >30 cubic centimetres (cc), measured by TRUS

6. Patient has had a bone-scan within 12 weeks before inclusion

7. Patient must be able to undergo transrectal examinations

8. Patient has an estimated life expectancy of at least 12 months

Exclusion Criteria:

1. Any previous treatments for prostate cancer

2. Previous trans-urethral resection of the prostate (TURP)

3. Is not considered a candidate for medical castration

4. Use of urethral catheter

5. Is currently treated with a 5-alpha reductase inhibitor

6. Is currently treated with an alpha-adrenoceptor antagonist

7. Treatment with botulinum toxin A (Botox)

8. Require radiotherapy during the trial

9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria
and/or angioedema

10. Hypersensitivity towards any component of the investigational products or excipients

11. Previous history or presence of another malignancy

12. A clinically significant disorder

13. A corrected QT interval over 450 msec

14. Mental incapacity or language barrier precluding adequate understanding or
co-operation

15. Receipt of an investigational drug within the last 28 days proceeding screening

16. Previous participation in any degarelix trial

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)

Outcome Description:

TRUS is a method of measuring the size of the prostate.

Outcome Time Frame:

After treatment of 12 weeks compared to Baseline

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

Denmark: Danish Medicines Agency

Study ID:

FE200486 CS31

NCT ID:

NCT00884273

Start Date:

August 2009

Completion Date:

March 2011

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location