A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients

Study Overview
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Brief Summary
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This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as add-on therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.

Detailed Description
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This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as add-on therapy for prostate cancer in patients with mild to moderate vasomotor symptoms (hot flashes) following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must have at least 21 moderate to severe hot flashes weekly. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period. In addition, a brief physical evaluation will be done, diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation.

Official Title
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A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Cyproterone acetate 5
* Drug: Placebo
* Drug: Cyproterone acetate 15
* Drug: Cyproterone acetate 25


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate cancer patients who have undergone chemical or surgical castration History of hot flashes for at least 30 days Stable prostate cancer therapy for at least 45 days Exclusion Criteria: Uncontrolled diabetes or severe COPD History of thromboembolic disease Liver or kidney dysfunction History or presence of cancer other than prostate cancer within the last 5 years Surgery within the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyproterone acetate 5 mg ( DR-2031)<br>1 tablet daily | Drug: Cyproterone acetate 5<br>* Cyproterone acetate 5 mg<br>* Other names: DR-2031;|
| Experimental: Cyproterone acetate 15 mg ( DR-2031)<br>1 tablet daily | Drug: Cyproterone acetate 15<br>* Cyproterone acetate 15 mg<br>* Other names: DR-2031;|
| Experimental: Cyproterone acetate 25 mg ( DR-2031)<br>1 tablet daily | Drug: Cyproterone acetate 25<br>* Cyproterone acetate 25 mg<br>* Other names: DR-2031;|
| Placebo Comparator: Placebo<br>1 tablet daily | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes |  | Throughout study | 
| To evaluate the safety compared to placebo |  | Throughout study | 
| Identify the lowest effective dose. |  | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy in reducing the severity of all hot flashes |  | Throughout study | 
| To compare the efficacy in elimination of all hot flashes |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, hot flashes, hot flushes, vasomotor symptoms