NCT05303558

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 24, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2023

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

March 22, 2022

Last Update Submit

August 1, 2024

Conditions

High Risk Localized Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Localized Prostate Cancer (LPC) Stage at Diagnosis

    Up to 2.5 years

  • Time from Diagnosis of LPC to Radical Prostatectomy (RP)

    Up to 2.5 years

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

    Up to 7.5 years

  • Hormonal Therapy Duration

    Up to 7.5 years

  • Yearly Conditional Local or Distant Radiographic PFS Probability

    Up to 5 years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Akita University Hospital

Akita, 010-8543, Japan

Location

Hirosaki University Hospital

Hirosaki, 036-8563, Japan

Location

Nagoya City University Hospital

Nagoya, 467-8602, Japan

Location

Yokohama City University Hospital

Yokohama, 236-0004, Japan

Location

Yokosuka Kyosai Hospital

Yokosuka, 238-8558, Japan

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Catholic Medical Center

Seoul, 06591, South Korea

Location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Study Officials

  • Johnson & Johnson International (Singapore) Pte Ltd Clinical Trial

    Johnson & Johnson International (Singapore) Pte. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

August 24, 2022

Primary Completion

June 7, 2023

Study Completion

June 7, 2023

Last Updated

August 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(5)KR(3)TW(1)