Prospective Prostate Cancer Infrastructure (ProPCI)
2026년 4월 28일 업데이트: Radboud University Medical Center
The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer.
This will help to better understand how these patients are treated in daily practice, how treatments affect quality of life, and facilitate biomarker discovery.
The infrastructure is also designed to enable future cohort multiple randomized controlled trials.
연구 개요
상태
아직 모집하지 않음
연구 유형
관찰
등록 (추정된)
700
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
해당 없음
샘플링 방법
비확률 샘플
연구 인구
All patients with treatment-naive high-risk localized and treatment-naive metastatic prostate carcinoma will be eligible to participate.
These patients are identified by their treating physicians in all participating hospitals.
설명
Inclusion Criteria:
- Diagnosis of either: high-risk localized prostate cancer (any of the following: PSA > 20 ng/mL, ISUP Grade Group 4 or 5, or clinical stage ≥ T2c); or metastatic prostate cancer confirmed by imaging (CT, bone scintigraphy, PSMA PET/CT, or (whole-body) MRI in combination with tumor markers (PSA)), or by biopsy of a metastatic lesion histopathologically deemed to be of prostatic origin.
- Prostate adenocarcinoma (our main focus). We will allow the inclusion of adenocarcinoma with mixed small- or large-cell neuroendocrine prostate
- Age ≥ 18 years at the time of inclusion.
- Written informed consent
- Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.
Exclusion Criteria:
- Not currently living in the Netherlands.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment patterns
기간: From diagnosis through study completion, up to 4 years
|
Documentation of initial and sequential treatment strategies, including type, timing, and combination of androgen deprivation therapy, androgen receptor pathway inhibitors, chemotherapy, and radiotherapy, within 4 months and beyond 4 months after diagnosis.
|
From diagnosis through study completion, up to 4 years
|
|
PSA response
기간: From treatment initiation up to 12 months.
|
Proportion of patients achieving >50% and >90% PSA decline from baseline within the first year after treatment initiation.
|
From treatment initiation up to 12 months.
|
|
PSA nadir
기간: From treatment initiation up to 12 months
|
Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir.
|
From treatment initiation up to 12 months
|
|
Utilization of imaging modalities for primary staging
기간: At baseline
|
Type and frequency of imaging modalities used at primary staging, including PSMA PET/CT, conventional CT, bone scintigraphy, and MRI.
|
At baseline
|
|
Time to clinical progression
기간: From treatment initiation through study completion, up to 4 years
|
Time from treatment initiation to clinical progression, defined as local progression, and/or symptomatic skeletal events (pain, fracture, spinal cord compression), or initiation of surgery or radiotherapy for progression.
|
From treatment initiation through study completion, up to 4 years
|
|
Time to biochemical progression
기간: From treatment initiation through study completion, up to 4 years
|
Time from treatment initiation to biochemical progression per PCWG3 criteria, defined as a minimum PSA rise of 25% AND an absolute increase of 2ng/mL from the nadir, confirmed on two measurements ≥3 weeks apart.
|
From treatment initiation through study completion, up to 4 years
|
|
Time to radiographic progression
기간: From treatment initiation through study completion, up to 4 years
|
Time from treatment initiation to radiographic progression based on imaging (conventional imaging, PSMA PET/CT), or RECIST 1.1 criteria.
|
From treatment initiation through study completion, up to 4 years
|
|
Time to castration-resistant prostate cancer (CRPC)
기간: From treatment initiation through study completion, up to 4 years
|
Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria.
|
From treatment initiation through study completion, up to 4 years
|
|
Overall survival
기간: From diagnosis through study completion, up to 4 years
|
Time from diagnosis to death from any cause.
|
From diagnosis through study completion, up to 4 years
|
|
Adverse events
기간: From treatment initiation through study completion, up to 4 years
|
Type, grade, and treatment-relatedness of adverse events occurring during treatment, graded according to the Common Terminology Criteria for Adverse Events version 5.0.
|
From treatment initiation through study completion, up to 4 years
|
|
Number of hospital admissions
기간: From treatment initiation through study completion, up to 4 years
|
Total number of planned and unplanned hospital admissions.
|
From treatment initiation through study completion, up to 4 years
|
|
Number of outpatient visits
기간: From treatment initiation through study completion, up to 4 years
|
Total number of outpatient visits
|
From treatment initiation through study completion, up to 4 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Dynamic change in ctDNA fraction
기간: Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.
|
Change in ctDNA fraction at 4-6 weeks and 9 months after start of initial treatment.
|
Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.
|
|
Prevalence and clinical phenotypes of genomic alterations
기간: At diagnosis or at disease progression, up to 4 years
|
Prevalence and clinical phenotype associations of somatic alterations in prostate cancer related genes and (likely) pathogenic germline variants, detected by cfDNA or tumor tissue.
|
At diagnosis or at disease progression, up to 4 years
|
|
Health-Related Quality of Life (Global Health Status)
기간: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
|
Clinically meaningful change in Global Health Status using the EORTC QLQ-C30 as a measure for Health Related Quality of Life, from baseline to sequential follow-up.
|
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
|
|
Health-Related Quality of Life (Health Utility)
기간: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months
|
Change in health utility index and EQ Visual Analogue Scale score measured using the EQ-5D-5L, across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
|
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months
|
|
Pain intensity and interference
기간: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
|
Change in average pain score and pain interference score measured using the Brief Pain Inventory - Short Form (BPI-SF).
|
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
|
|
Fatigue severity and interference
기간: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
|
Change in average fatigue score and fatigue interference score measured using the Brief Fatigue Inventory (BFI).
|
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
|
|
Prostate cancer-specific symptoms
기간: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
|
Change in prostate cancer-specific symptoms measured using the EORTC QLQ-PR25, domain scores for urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning.
|
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2030년 5월 1일
연구 완료 (추정된)
2030년 5월 1일
연구 등록 날짜
최초 제출
2026년 4월 16일
QC 기준을 충족하는 최초 제출
2026년 4월 28일
처음 게시됨 (실제)
2026년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 28일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025-18407
- NL-OMON58526 (레지스트리 식별자: OMON)
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