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

Sponsor
Johnson & Johnson Pte Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05303558
Collaborator
(none)
600
1
8
75.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Mar 31, 2023
    Anticipated Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability [Up to 5 years]

      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.

    Secondary Outcome Measures

    1. Localized Prostate Cancer (LPC) Stage at Diagnosis [Up to 2.5 years]

      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).

    2. Time from Diagnosis of LPC to Radical Prostatectomy (RP) [Up to 2.5 years]

      Time from diagnosis of LPC to RP will be reported.

    3. Number of Participants who Received Treatments Provided with RP and Following RP [Up to 7.5 years]

      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.

    4. Hormonal Therapy Duration [Up to 7.5 years]

      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.

    5. Yearly Conditional Local or Distant Radiographic PFS Probability [Up to 5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akita University Hospital Akita Japan 010-8543

    Sponsors and Collaborators

    • Johnson & Johnson Pte Ltd

    Investigators

    • Study Director: Johnson & Johnson Pte Ltd Clinical Trial, Johnson & Johnson Pte Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Pte Ltd
    ClinicalTrials.gov Identifier:
    NCT05303558
    Other Study ID Numbers:
    • CR109188
    • NOPRODPCR4002
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022