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

Johnson & Johnson (J&J)

Status: Completed

Conditions: High Risk Localized Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT05303558

CR109188

NOPRODPCR4002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

221 participants in 1 patient group

Participants With High-risk Localized Prostate Cancer

Description:

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.