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OpenTrials
Completed

NCT Number: NCT00672282

Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

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.

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Key information

Conditions

Non-Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bicalutamide

Drug

150mg p.o. daily

Other names: Casodex

Placebo

Drug

Primary outcomes

  1. Survival

    Time frame: Throughout study period

  2. Time to clinical progression

    Time frame: Throughout study period

Secondary outcomes

  1. Tolerability in terms of adverse events and laboratory parameters

    Time frame: Throughout study period

  2. Time to treatment failure

    Time frame: Throughout study period

  3. Prostate-specific antigen

    Time frame: Initial study period up to 2005 amended protocol

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Scandinavian Prostate Cancer Group

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.

Acronym: SPCG6

Important dates

Study start
1995
Study completion
2008
First posted
May 6, 2008
Registry last updated
May 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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