Clinical trial · Interventional
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyproterone acetate 15 | Drug | Cyproterone Acetate | ALIAS |
| Cyproterone acetate 25 | Drug | Cyproterone Acetate | ALIAS |
| Cyproterone acetate 5 | Drug | Cyproterone Acetate | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cyproterone acetate 5 mg ( DR-2031)
- description
- 1 tablet daily
- interventionNames
- Drug: Cyproterone acetate 5
- type
- EXPERIMENTAL
- label
- Cyproterone acetate 15 mg ( DR-2031)
- description
- 1 tablet daily
- interventionNames
- Drug: Cyproterone acetate 15
- type
- EXPERIMENTAL
- label
- Cyproterone acetate 25 mg ( DR-2031)
- description
- 1 tablet daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available