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Completed

NCT Number: NCT05303558

A Study of High Risk Localized Prostate Cancer Participants 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.

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Key information

Conditions

High Risk Localized Prostate Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akita University Hospital, Akita, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • >= 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Localized Prostate Cancer (LPC) Stage at Diagnosis

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson International (Singapore) Pte. Ltd.

Industry

Registry information

Official study title

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

Acronym: ACE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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