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

Johnson & Johnson International (Singapore) Pte. Ltd.221 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

221

Conditions

High Risk Localized Prostate Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis

Locations (9)

Akita University Hospital

Akita, Japan

Hirosaki University Hospital

Hirosaki, Japan

Nagoya City University Hospital

Nagoya, Japan

Yokohama City University Hospital

Yokohama, Japan

Outcomes

Primary Outcomes

Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability

PSA PFS probability is defined as probability of being PSA progression free given that participant has yet to experience PSA progression or death from any cause. PSA progression is defined as per the prostate cancer working group 2 (PCWG2) consensus.

Time frame: Up to 5 years

Secondary Outcomes

Localized Prostate Cancer (LPC) Stage at Diagnosis

LPC stage at diagnosis will be based on the latest tumor nodes and metastases (TNM) staging system approved by the American Joint Committee on Cancer (AJCC).

Time frame: Up to 2.5 years

Time from Diagnosis of LPC to Radical Prostatectomy (RP)

Time from diagnosis of LPC to RP will be reported.

Time frame: Up to 2.5 years

Number of Participants who Received Treatments Provided with RP and Following RP

Number of participants who received treatments provided with RP and following RP (including RP and neo-adjuvant hormonal therapy only, RP and adjuvant hormonal therapy only, or RP and both neoadjuvant and adjuvant hormonal therapies) will be reported.

Time frame: Up to 7.5 years

Hormonal Therapy Duration

Hormonal therapy duration is defined as the length of time between the start date of receiving hormonal therapy treatment and the date of receiving last dose.

Time frame: Up to 7.5 years

Yearly Conditional Local or Distant Radiographic PFS Probability

Conditional radiographic PFS probability is defined as the probability of being radiographic progression-free given that participant has yet to experience local or distant radiographic progression.

Data from ClinicalTrials.gov

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