Clinical trial NCT00672282: Casodex vs Placebo in Non-Metastatic Early Prostate Cancer
Official title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Metastatic Prostate Cancer
Keywords: androgen antagonists
prostate neoplasms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Scandinavian Prostate Cancer Group
First posted: 2008-05-06
Enrollment: 1218
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of non-metastatic cancer of the prostate gland
* Patient to be 18 years and above

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.

Primary outcomes:
measure: Survival
timeFrame: Throughout study period
measure: Time to clinical progression
timeFrame: Throughout study period
Secondary outcomes:
measure: Tolerability in terms of adverse events and laboratory parameters
timeFrame: Throughout study period
measure: Time to treatment failure
timeFrame: Throughout study period
measure: Prostate-specific antigen
timeFrame: Initial study period up to 2005 amended protocol
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Site
city: Charlottenlund
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Frederiksberg
country: Denmark
facility: Research Site
city: Frederikssund
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Holbuk
country: Denmark
facility: Research Site
city: Kobenhavn
country: Denmark
facility: Research Site
city: Nyk Bing Falster
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Orhus
country: Denmark
facility: Research Site
city: Randers
country: Denmark
facility: Research Site
city: S Nderborg
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Joensuu
country: Finland
facility: Research Site
city: Kokkola
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Lahti
country: Finland
facility: Research Site
city: Lappeenranta
country: Finland
facility: Research Site
city: Oys (oulu)
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Bodu
country: Norway
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Harstad
country: Norway
facility: Research Site
city: Kristiansand
country: Norway
facility: Research Site
city: Lesund
country: Norway
facility: Research Site
city: Levanger
country: Norway
facility: Research Site
city: Lillehammer
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Porsgrunn
country: Norway
facility: Research Site
city: RUD
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Strummen
country: Norway
facility: Research Site
city: Tromsu
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Tunsberg
country: Norway
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Govle
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Hudiksvall
country: Sweden
facility: Research Site
city: Junkoping
country: Sweden
facility: Research Site
city: Kristinehamn
country: Sweden
facility: Research Site
city: Luleo
country: Sweden
facility: Research Site
city: Malmu
country: Sweden
facility: Research Site
city: Norrkoping
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Urebro
country: Sweden
facility: Research Site
city: Ustersund
country: Sweden
facility: Research Site
city: VoSTEROS
country: Sweden
facility: Research Site
city: Vostervik
country: Sweden
facility: Research Site
Study officials:
affiliation: Department of Urology Rigshospitalet Copenhagen Denmark
name: Peter Iversen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomsen FB, Brasso K, Berg KD, Gerds TA, Johansson JE, Angelsen A, Tammela TL, Iversen P; Scandinavian Prostate Cancer Group. Association between PSA kinetics and cancer-specific mortality in patients with localised prostate cancer: analysis of the placebo arm of the SPCG-6 study. Ann Oncol. 2016 Mar;27(3):460-6. doi: 10.1093/annonc/mdv607. Epub 2015 Dec 17.
citation: Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81. doi: 10.1111/j.1464-410X.2010.09319.x.