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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Cyproterone acetate 25; Drug: Cyproterone acetate 15; Drug: Cyproterone acetate 5; Drug: Placebo

• Registration Number: NCT00196339
• Lead Sponsor: Duramed Research

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Disposition First Submitted: 2013-08-27
• Disposition First Submitted QC: 2013-08-27
• Disposition First Posted: 2013-09-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyproterone acetate 25 mg ( DR-2031)	Cyproterone acetate 25	1 tablet daily
Cyproterone acetate 15 mg ( DR-2031)	Cyproterone acetate 15	1 tablet daily
Cyproterone acetate 5 mg ( DR-2031)	Cyproterone acetate 5	1 tablet daily
Placebo	Placebo	1 tablet daily

Primary Outcome Measures

Name	Time	Method
Identify the lowest effective dose.	End of study
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

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy in elimination of all hot flashes	Throughout study
To compare the efficacy in reducing the severity of all hot flashes	Throughout study

Trial Locations

Locations (3)

Duramed Investigational Site; 🇨🇦 Pointe-Claire, Quebec, Canada

Duramed Investiational Site; 🇺🇸 Ocala, Florida, United States

Duramed Investigational site; 🇺🇸 Garden City, New York, United States