A Study of High Risk Localized Prostate Cancer Participants Treated With Radical Prostatectomy and Perioperative Hormonal Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-24

Study Completion Date

2023-06-07

Brief Summary

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The purpose of this study is to evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival (PFS) probabilities in high-risk localized prostate cancer (HR LPC) participants following radical prostatectomy (RP) and perioperative hormonal therapies (that is, hormonal treatment before RP and / or after RP) over 5 years.

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Detailed Description

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Conditions

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High Risk Localized Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants With High-risk Localized Prostate Cancer

Adult participants from Japan, South Korea, and Taiwan with high-risk localized prostate cancer (HR LPC) who received radical prostatectomy (RP) and perioperative (neoadjuvant and/ or adjuvant) hormonal therapy will be observed from the date of confirmed HR LPC diagnosis until death, lost to follow-up (last known visit), or end of study period, whichever comes first. This study will utilize data from electronic medical records (EMR) in South Korea and Taiwan, and data from chart reviews in Japan. Data will be analyzed retrospectively from 1 January 2015 to 30 June 2017, with a follow-up till 30 June 2022.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants who have histologically confirmed adenocarcinoma of the prostate
* Participants newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive)
* Participants fulfil high-risk localized prostate cancer defined by national comprehensive cancer network (NCCN) prostate cancer guideline (2020 version 1) a. T3a or; b. Grade group 4 or Grade group 5 or; c. Prostate specific antigen (PSA) greater than (\>) 20 nanograms per milliliter (ng/mL)
* Participants must have received radical prostatectomy (RP) between 1 January 2015 and 30 June 2017
* Participants must have received at least one perioperative hormonal therapy pattern as listed below:

1. greater than or equal to (\>=) 3 months neoadjuvant hormonal therapy, duration between date of last dose and date of RP should be less than or equal to (\<=) 2 months; and/or
2. \>= 6 months adjuvant hormonal therapy, first dose started within 6 months of RP surgery