Last updated: 11/07/2018 15:40:49
A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety And Preliminary Efficacy of Neoadjuvant Therapy With GI198745 in Subjects With Localized Prostate Cancer Undergoing Radical Prostatectomy.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety And Preliminary Efficacy of Neoadjuvant Therapy With GI198745 in Subjects With Localized Prostate Cancer Undergoing Radical Prostatectomy.
Trial description: A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety And Preliminary Efficacy of Neoadjuvant Therapy With GI198745 in Subjects With Localized Prostate Cancer Undergoing Radical Prostatectomy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Andriole G, Humphrey P, Ray P, et al. Effect of the dual 5alpha-reductase Inhibitor dutasteride on markers of regression in prostate cancer. AUA 2004
Andriole G, Ray P, Humphrey P, et al. The impact of dutasteride, a novel dual 5alpha-reductase inhibitor on both serum and intraprostatic androgens. EAU 2003
Andriole GL, Humphrey P, Ray P et al. Effect of the dual 5 alpha-reductase inhibitor dutasteride on markers of tumor regression in prostate cancer. J Urol 2004; 172:915919
Medical condition
Neoplasms, Prostate
Product
dutasteride
Collaborators
Not applicable
Study date(s)
June 1997 to February 2001
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2001-23-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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