Clinical trial NCT05303558: A Study of High Risk Localized Prostate Cancer Participants Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
Official title: Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Risk Localized Prostate Cancer
Lead sponsor: Johnson & Johnson International (Singapore) Pte. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability
timeFrame: Up to 5 years
Secondary outcomes:
measure: Localized Prostate Cancer (LPC) Stage at Diagnosis
timeFrame: Up to 2.5 years
measure: Time from Diagnosis of LPC to Radical Prostatectomy (RP)
timeFrame: Up to 2.5 years
measure: Number of Participants who Received Treatments Provided with RP and Following RP
timeFrame: Up to 7.5 years
measure: Hormonal Therapy Duration
timeFrame: Up to 7.5 years
measure: Yearly Conditional Local or Distant Radiographic PFS Probability
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Akita
country: Japan
facility: Akita University Hospital
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic Medical Center
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Johnson & Johnson International (Singapore) Pte. Ltd.
name: Johnson & Johnson International (Singapore) Pte Ltd Clinical Trial
role: STUDY_DIRECTOR
References: