(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer
NCT00673205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3588
Last updated 2010-12-10
Summary
The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
Conditions
- Non-Metastatic Prostate Cancer
Interventions
- DRUG
-
Bicalutamide
150mg p.o. daily
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Manfred P Wirth, Professor · Technical University of Dresden, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1995-09-30
- Primary Completion
- 2008-08-31
- Completion
- 2008-08-31
Countries
- Australia
- Austria
- Belgium
- Czechia
- Germany
- Hungary
- Ireland
- Israel
- Italy
- Mexico
- Netherlands
- Poland
- Portugal
- South Africa
- Spain
- United Kingdom
Study Locations
More Related Trials
-
Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer
NCT00846976 ·Status: COMPLETED ·Phase: PHASE3
-
Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer
NCT01050842 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
NCT00659438 ·Status: COMPLETED ·Phase: PHASE2
-
Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients.
NCT00554086 ·Status: COMPLETED ·Phase: PHASE2
-
Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
NCT00551044 ·Status: COMPLETED ·Phase: NA
-
Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer
NCT00014586 ·Status: TERMINATED ·Phase: PHASE3
-
Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
NCT00002874 ·Status: COMPLETED ·Phase: PHASE3
-
Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer
NCT00658697 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After Castration
NCT00878436 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
NCT01288911 ·Status: COMPLETED ·Phase: PHASE2
-
Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
NCT01251861 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Clinical Trial to Study Quality of Life in Prostate Cancer Patients by Randomizing Anti-androgen Versus Total Androgen Blockage Prior to Curative Intended Radiation Therapy
NCT02382094 ·Status: COMPLETED ·Phase: PHASE3
-
Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)
NCT00777959 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer
NCT00430235 ·Status: COMPLETED ·Phase: PHASE2
-
BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
NCT02204072 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
NCT01946204 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
NCT00630344 ·Status: COMPLETED ·Phase: PHASE2
-
Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer
NCT01200810 ·Status: TERMINATED ·Phase: PHASE2
-
Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
NCT01120236 ·Status: COMPLETED ·Phase: PHASE2
-
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
NCT00776594 ·Status: COMPLETED ·Phase: PHASE2
-
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
NCT00056407 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
NCT01664923 ·Status: COMPLETED ·Phase: PHASE2
-
Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
NCT00021450 ·Status: COMPLETED ·Phase: PHASE3
-
Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer
NCT00814788 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
NCT00521781 ·Status: TERMINATED ·Phase: PHASE2