Casodex - Nolvadex Combination
Status and phase
Completed
Phase 2
Conditions
Gynaecomastia
Prostate Cancer
Treatments
Drug: Tamoxifen
Drug: Casodex
Details and patient eligibility
About
This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.
Sex
Male
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
0 participants in 2 patient groups
1
Experimental group
Treatment:
Drug: Casodex
2
Active Comparator group
Treatment:
Drug: Tamoxifen
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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