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Casodex vs Placebo in Non-Metastatic Early Prostate Cancer (SPCG6)

Primary Purpose

Non-Metastatic Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bicalutamide
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Metastatic Prostate Cancer focused on measuring androgen antagonists, prostate neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Survival
Time to clinical progression

Secondary Outcome Measures

Tolerability in terms of adverse events and laboratory parameters
Time to treatment failure
Prostate-specific antigen

Full Information

First Posted
May 2, 2008
Last Updated
May 26, 2009
Sponsor
AstraZeneca
Collaborators
Scandinavian Prostate Cancer Group
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1. Study Identification

Unique Protocol Identification Number
NCT00672282
Brief Title
Casodex vs Placebo in Non-Metastatic Early Prostate Cancer
Acronym
SPCG6
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

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca
Collaborators
Scandinavian Prostate Cancer Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Metastatic Prostate Cancer
Keywords
androgen antagonists, prostate neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex
Intervention Description
150mg p.o. daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Survival
Time Frame
Throughout study period
Title
Time to clinical progression
Time Frame
Throughout study period
Secondary Outcome Measure Information:
Title
Tolerability in terms of adverse events and laboratory parameters
Time Frame
Throughout study period
Title
Time to treatment failure
Time Frame
Throughout study period
Title
Prostate-specific antigen
Time Frame
Initial study period up to 2005 amended protocol

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Iversen, MD
Organizational Affiliation
Department of Urology Rigshospitalet Copenhagen Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
Research Site
City
Charlottenlund
Country
Denmark
Facility Name
Research Site
City
Esbjerg
Country
Denmark
Facility Name
Research Site
City
Frederiksberg
Country
Denmark
Facility Name
Research Site
City
Frederikssund
Country
Denmark
Facility Name
Research Site
City
Glostrup
Country
Denmark
Facility Name
Research Site
City
Herlev
Country
Denmark
Facility Name
Research Site
City
Holbuk
Country
Denmark
Facility Name
Research Site
City
Kobenhavn
Country
Denmark
Facility Name
Research Site
City
Nyk Bing Falster
Country
Denmark
Facility Name
Research Site
City
Odense
Country
Denmark
Facility Name
Research Site
City
Orhus
Country
Denmark
Facility Name
Research Site
City
Randers
Country
Denmark
Facility Name
Research Site
City
S Nderborg
Country
Denmark
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Joensuu
Country
Finland
Facility Name
Research Site
City
Kokkola
Country
Finland
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
Research Site
City
Lahti
Country
Finland
Facility Name
Research Site
City
Lappeenranta
Country
Finland
Facility Name
Research Site
City
Oys (oulu)
Country
Finland
Facility Name
Research Site
City
Tampere
Country
Finland
Facility Name
Research Site
City
Turku
Country
Finland
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Bodu
Country
Norway
Facility Name
Research Site
City
Drammen
Country
Norway
Facility Name
Research Site
City
Fredrikstad
Country
Norway
Facility Name
Research Site
City
Harstad
Country
Norway
Facility Name
Research Site
City
Kristiansand
Country
Norway
Facility Name
Research Site
City
Lesund
Country
Norway
Facility Name
Research Site
City
Levanger
Country
Norway
Facility Name
Research Site
City
Lillehammer
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Porsgrunn
Country
Norway
Facility Name
Research Site
City
RUD
Country
Norway
Facility Name
Research Site
City
Stavanger
Country
Norway
Facility Name
Research Site
City
Strummen
Country
Norway
Facility Name
Research Site
City
Tromsu
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Tunsberg
Country
Norway
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Govle
Country
Sweden
Facility Name
Research Site
City
Helsingborg
Country
Sweden
Facility Name
Research Site
City
Hudiksvall
Country
Sweden
Facility Name
Research Site
City
Junkoping
Country
Sweden
Facility Name
Research Site
City
Kristinehamn
Country
Sweden
Facility Name
Research Site
City
Luleo
Country
Sweden
Facility Name
Research Site
City
Malmu
Country
Sweden
Facility Name
Research Site
City
Norrkoping
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Urebro
Country
Sweden
Facility Name
Research Site
City
Ustersund
Country
Sweden
Facility Name
Research Site
City
VoSTEROS
Country
Sweden
Facility Name
Research Site
City
Vostervik
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26681677
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.
Results Reference
derived
PubMed Identifier
22129214
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.
Results Reference
derived

Learn more about this trial

Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

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