Status:
COMPLETED
A Study of High Risk Localized Prostate Cancer Participants Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
Lead Sponsor:
Johnson & Johnson International (Singapore) Pte. Ltd.
Conditions:
High Risk Localized Prostate Cancer
Eligibility:
All Genders
18+ years
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) participan...
Eligibility Criteria
Inclusion
- 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
- Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis
Key Trial Info
Start Date :
August 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 7 2023
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT05303558
Start Date
August 24 2022
End Date
June 7 2023
Last Update
August 5 2024
Active Locations (9)
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1
Akita University Hospital
Akita, Japan, 010-8543
2
Hirosaki University Hospital
Hirosaki, Japan, 036-8563
3
Nagoya City University Hospital
Nagoya, Japan, 467-8602
4
Yokohama City University Hospital
Yokohama, Japan, 236-0004