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

NCT06733337 | Active Not Recruiting

• 1 other identifier: C3441050
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

BRCA mutation-positive; metastatic castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse drug reactions

  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.

  Up to 52 weeks

Eligibility Criteria

• Age: 0 Years+
• Gender Eligibility Details: The target disease, prostate cancer, is specific to male.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who satisfy the inclusion criteria

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Japan

Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: July 11, 2025
• Primary Completion (Estimated): June 22, 2029
• Study Completion (Estimated): June 22, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)