A Study to Learn About the Awareness and Knowledge That Doctors Have About the Safety and Safe Use Information for Androcur and Other Cyproterone Acetate Treatments in Europe

Prostate Cancer Clinical Trial

— Safe-CAM  

Official title:

Study to Evaluate Physician Awareness and Knowledge of Safety and Safe Use Information for Androcur and Other Cyproterone Acetate Monotherapies in Europe: an Observational Post-Authorisation Joint Safety Study (Safe-CAM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925180
• Other study ID #: 21490
• Status: Completed
• Start date: October 18, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Androcur is a type of treatment called cyproterone acetate (CPA). Androcur and other CPA treatments work by blocking a group of male sex hormones called androgens in the body. It can be given to men and women to treat conditions that are caused by higher levels of androgens. CPAs, including androcur, are currently available as treatments for doctors to give to patients who have these types of conditions. But, in a study, researchers found that participants had a certain medical problem when they took CPAs for a long time. This medical problem was a tumor of the brain or spinal cord that is mostly not malignant and is called meningioma. This eventually led health authorities to change the instructions for how doctors should use CPAs to treat patients. This included what health conditions should be treated with CPAs, how long patients should receive them, and what dose of CPA should be given. In this study, the researchers want to learn more about how doctors are using CPAs to treat patients after the update to the instructions. To answer this research question, they will give to the doctors a web-based questionnaire asking about the advisability or necessity of the treatment (also called "indications of approved use"), the measures to be followed to reduce the risk and how much the doctors knew about the risk of meningioma. The researches will then analyze the answers to the questionnaire. The results will be the percentage of physicians with correct answers for each individual knowledge question from the questionnaire. The study will include information collected from a diverse sample of doctors during approximately 3 months. The doctors must have given CPAs as a treatment to at least 1 patient in the last 12 months. There are no required visits or tests in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Licensed and practising dermatologist, endocrinologist, gynaecologist, general practitioners, urologist, oncologist (who treats prostate cancer), or psychiatrist involved in the treatment of hypersexuality/reduction of drive in sexual deviations
• Prescribed CPA monotherapy to at least one patient in the past 12 months
• Work in an office or hospital-based setting
• Electronic acknowledgement of informed consent

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Alopecia
• Hirsutism
• Prostate Cancer

Intervention

Drug:
• Cyproterone Acetate (Androcur, BAY94-8367)
As prescribed by the treating physician

Locations

Country	Name	City	State
France	Many Locations	Multiple Locations
Germany	Many Locations	Multiple Locations
Netherlands	Many Locations	Multiple Locations
Poland	Many Locations	Multiple Locations
Spain	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of physicians responding correctly to the knowledge question: The occurrence of meningiomas (single and multiple) in association with CPA monotherapy doses = 25 mg/day		Baseline
Primary	Percentage of physicians responding correctly to the knowledge question: Restriction of use of CPA monotherapy 10 mg/50 mg in women when no results have been achieved at lower dose CPA-containing products or with other treatment options		Baseline
Primary	Percentage of physicians responding correctly to the knowledge question: Restriction of use of high-dose CPA in men with sexual deviations when other interventions are not appropriate		Baseline
Primary	Percentage of physicians responding correctly to the knowledge question: After clinical improvement with CPA monotherapy is achieved, treatment should be maintained with the lowest possible dose		Baseline
Primary	Percentage of physicians responding correctly to the knowledge question: The risk of meningioma increases with increasing cumulative doses of CPA		Baseline
Primary	Percentage of physicians responding correctly to the knowledge question: CPA is contraindicated in patients with a meningioma or a history of meningioma		Baseline
Primary	Percentage of physicians responding correctly to the knowledge question: If a patient treated with CPA monotherapy is diagnosed with meningioma, treatment with all cyproterone-containing products must be permanently stopped		Baseline
Primary	Percentage of physicians responding correctly to the knowledge question: Awareness of signs and symptoms of meningiomas		Baseline