NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05303558

CompletedN/A

Sponsor: Johnson & Johnson International (Singapore) Pte. Ltd.

Conditions: High Risk Localized Prostate Cancer

Countries: Japan, South Korea, Taiwan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (9)

Akita, Japan
Hirosaki, Japan
Nagoya, Japan
Yokohama, Japan
Yokosuka, Japan
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Taoyuan City, Taiwan