A Study of High Risk Localized Prostate Cancer Participants Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
- Conditions
- High Risk Localized Prostate Cancer
- Registration Number
- NCT05303558
- Lead Sponsor
- Johnson & Johnson International (Singapore) Pte. Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
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Participants who have histologically confirmed adenocarcinoma of the prostate
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Participants newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive)
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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)
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Participants must have received radical prostatectomy (RP) between 1 January 2015 and 30 June 2017
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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
- Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability 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 Outcome Measures
Name Time Method Time from Diagnosis of LPC to Radical Prostatectomy (RP) Up to 2.5 years Time from diagnosis of LPC to RP will be reported.
Hormonal Therapy Duration 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.
Number of Participants who Received Treatments Provided with RP and Following RP 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.
Yearly Conditional Local or Distant Radiographic PFS Probability 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.
Localized Prostate Cancer (LPC) Stage at Diagnosis 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).
Trial Locations
- Locations (9)
Akita University Hospital
🇯🇵Akita, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Japan
Yokosuka Kyosai Hospital
🇯🇵Yokosuka, Japan
Hirosaki University Hospital
🇯🇵Hirosaki, Japan
Nagoya City University Hospital
🇯🇵Nagoya-shi, Japan
Catholic Medical Center
🇰🇷Seoul, Korea, Republic of
Chang Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of