CClinicalTrials.gg
Active, not recruitingNCT06733337Updated Nov 17, 2025

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

An observational study in Prostate Cancer, sponsored by Pfizer. Active, not recruiting at 1 site in Japan. Open to male participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
0 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • BRCA mutation-positive
  • metastatic castration-resistant prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 1 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who satisfy the inclusion criteria

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: Up to 52 weeks

07

Study locations

1 site
  • Pfizer Japan
    Tokyo, Japan
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06733337
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 13, 2024
Start date
Jul 11, 2025
Primary completion
Jun 22, 2029 (estimated)
Completion
Jun 22, 2029 (estimated)
Last update
Nov 17, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion