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Randomised, Double-blind, Placebo Controlled, Parallel-group, Multicentre Phase II Study to Assess Dose Response Relationship of Nolvadex (Oral Tablet) in Prophylactic Treatment of Gynaecomastia and Breast Pain Associated With CASODEX 150 mg (Oral Tablet), and to Assess the Tumour Control…..


Phase 2
N/A
N/A
Not Enrolling
Male
Gynaecomastia, Prostate Cancer

Thank you

Trial Information

Randomised, Double-blind, Placebo Controlled, Parallel-group, Multicentre Phase II Study to Assess Dose Response Relationship of Nolvadex (Oral Tablet) in Prophylactic Treatment of Gynaecomastia and Breast Pain Associated With CASODEX 150 mg (Oral Tablet), and to Assess the Tumour Control…..


Inclusion Criteria:



- Subjects with adenocarcinoma of the prostate gland but with no evidence of distant
metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically
or cytologically

- Subjects in need of immediate hormonal therapy.

- PSA equal or above 4 ng/ml

Exclusion Criteria:

- Presence of gynaecomastia and/or breast pain at screening visit

- Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH
therapy prior to primary therapy of curative intent.

- Current use, or within the previous 6 months, of any medication known to have a high
risk of causing gynaecomastia .

- Previous mastectomy or radiation to chest wall

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Yves Fradet, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Quebec City

Authority:

United States: Food and Drug Administration

Study ID:

7054IL/0044

NCT ID:

NCT00637871

Start Date:

November 2002

Completion Date:

August 2005

Related Keywords:

  • Gynaecomastia
  • Prostate Cancer
  • Casodex
  • bicalutamide
  • Tamoxifen
  • Gynaecomastia
  • Prostate Cancer
  • Gynecomastia
  • Prostatic Neoplasms

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