A Study to Learn About the Safety of TALZENNA in People With Prostate Cancer.

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06733337
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn about the safety of TALZENNA in patients with BRCA mutation-positive metastatic castration-resistant prostate cancer. BRCA mutation positive means any changes to the BRCA gene. Metastasis means the cancer that has spread to other parts of the body. Castration-resistant prostate cancer means the prostate cancer that keeps growing even when the amount of male sex hormone in the body is reduced to very low levels. Prostate is a male sex organ.

The study is seeking for participants:

* with BRCA mutation-positive metastatic castration-resistant prostate cancer

* who have not used this study medicine before. All patients in this study will receive TALZENNA according to the prescriptions.

Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Study Start: 2025-07-31
• Primary Completion: 2029-06-22
• Study Completion: 2029-06-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 104

Inclusion Criteria

• Patients with BRCA mutation-positive metastatic castration-resistant prostate cancer
• No history of previous use of this drug

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions	Up to 52 weeks	For adverse drug reactions corresponding to myelosuppression, interstitial lung disease, thromboembolism, and secondary malignant tumour, the incidence, time of onset, grade, outcome etc. will be tabulated.