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

Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy

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 Overview

• Status: Completed
• Conditions: High Risk Localized Prostate Cancer

• Study Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Hirosaki, Japan, 036-8563
    • Hirosaki University Hospital
  • Nagoya-shi, Japan, 467-8602
    • Nagoya City University Hospital
  • Yokohama, Japan, 236-0004
    • Yokohama City University Hospital
  • Yokosuka, Japan, 238-8558
    • Yokosuka Kyosai Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • Catholic Medical Center
• Taiwan
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population includes newly diagnosed adult high-risk localized prostate cancer (HR LPC) participants who received radical prostatectomy (RP) and perioperative hormonal therapy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 2.5 years
Time from Diagnosis of LPC to Radical Prostatectomy (RP)	Time from diagnosis of LPC to RP will be reported.	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.	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.	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.	Up to 5 years

Collaborators and Investigators

• Sponsor: Johnson & Johnson International (Singapore) Pte. Ltd.
• Investigators: Study Director: Johnson & Johnson International (Singapore) Pte Ltd Clinical Trial, Johnson & Johnson International (Singapore) Pte. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CR109188; NOPRODPCR4002 (Other Identifier: Johnson & Johnson International (Singapore) Pte Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No