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

Special Investigation of TALZENNA Capsules - Study on BRCA Mutation-Positive Metastatic Castration-Resistant Prostate Cancer -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06733337

Enrollment

Registered

2024-12-13

Start date

2025-07-11

Completion date

2029-06-22

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

BRCA mutation-positive, metastatic castration-resistant prostate cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

0 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Japan

Outcome results