PMID- 31411970
OWN - NLM
STAT- MEDLINE
DCOM- 20200619
LR  - 20200619
IS  - 2588-9311 (Electronic)
IS  - 2588-9311 (Linking)
VI  - 2
IP  - 5
DP  - 2019 Sep
TI  - Follow-up in Active Surveillance for Prostate Cancer: Strict Protocol Adherence 
      Remains Important for PRIAS-ineligible Patients.
PG  - 483-489
LID - S2588-9311(19)30011-2 [pii]
LID - 10.1016/j.euo.2019.01.010 [doi]
AB  - BACKGROUND: Active surveillance (AS) is a safe treatment strategy for men with 
      low-risk prostate cancer (PC) when performed in a research setting using strict 
      follow-up. However, less is known about the protocol adherence and outcomes for 
      AS in real-world practice. OBJECTIVE: To evaluate Prostate Cancer Research 
      International Active Surveillance (PRIAS) protocol adherence in a real-world 
      cohort and to relate follow-up intensity to oncological safety. DESIGN, SETTING, 
      AND PARTICIPANTS: Patients with biopsy-detected PC diagnosed from 2008 to 2014 
      treated with AS at six teaching hospitals in The Netherlands. INTERVENTION: AS 
      included regular prostate-specific antigen (PSA) testing (every 3-6mo) combined 
      with a confirmatory biopsy 1yr after diagnosis and every 3yr thereafter. OUTCOME 
      MEASUREMENTS AND STATISTICAL ANALYSIS: The proportions of patients complying with 
      the PRIAS biopsy and PSA monitoring protocol were determined. We assessed if 
      PRIAS-discordant follow-up was associated with a higher risk of metastasis 
      compared with PRIAS-concordant follow-up using Cox regression analysis. Analysis 
      was performed for separate risk groups (PRIAS-eligible and PRIAS-ineligible) on 
      the basis of the PRIAS inclusion criteria. RESULTS AND LIMITATIONS: Of all 
      patients on AS for >6mo, 706/958 (74%) had PRIAS-concordant PSA monitoring. 
      Overall concordant follow-up (PSA and repeat biopsy) was observed in 415/958 
      patients (43%). The percentage of patients with overall concordant follow-up 
      varied between hospitals (range 34-60%; p<0.001). Among PRIAS-ineligible 
      patients, PRIAS-discordant PSA monitoring was associated with a higher risk of 
      developing PC metastases during AS compared with patients with concordant 
      follow-up (hazard ratio 5.25, 95% confidence interval 1.02-27.1). In the 
      PRIAS-eligible population, we found no significant differences regarding rates of 
      metastases between patients with discordant and concordant follow-up. 
      CONCLUSIONS: We observed substantial variation in AS follow-up intensity between 
      large urological practices in the Netherlands. Overall, 43% of patients on AS in 
      daily clinical practice receive PRIAS-concordant follow-up. Noncompliance with 
      the PRIAS follow-up protocol was associated with a higher rate of metastasis 
      among PRIAS-ineligible patients, indicating that strict protocol adherence is 
      important when these patients opt for AS. PATIENT SUMMARY: Fewer than half of 
      patients with prostate cancer on active surveillance are monitored according to 
      the follow-up protocol of the largest ongoing active surveillance study. 
      Lower-intensity monitoring may be less safe for patients who are not in the 
      lowest risk group.
CI  - Copyright (c) 2019 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Soeterik, Timo F W
AU  - Soeterik TFW
AD  - Santeon Hospital Group, Utrecht, The Netherlands. Electronic address: 
      t.soeterik@antoniusziekenhuis.nl.
FAU - van Melick, Harm H E
AU  - van Melick HHE
AD  - Department of Urology, St. Antonius Hospital, Nieuwegein/Utrecht, The 
      Netherlands.
FAU - Dijksman, Lea M
AU  - Dijksman LM
AD  - Department of Value-Based Healthcare, St. Antonius Hospital, 
      Nieuwegein/Utrecht,The Netherlands.
FAU - Biesma, Douwe H
AU  - Biesma DH
AD  - Department of Value-Based Healthcare, St. Antonius Hospital, 
      Nieuwegein/Utrecht,The Netherlands.
FAU - Witjes, J Alfred
AU  - Witjes JA
AD  - Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The 
      Netherlands.
FAU - van Basten, Jean-Paul A
AU  - van Basten JA
AD  - Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190210
PL  - Netherlands
TA  - Eur Urol Oncol
JT  - European urology oncology
JID - 101724904
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
MH  - Aftercare/*standards
MH  - Aged
MH  - Biopsy, Large-Core Needle/standards/statistics & numerical data
MH  - Disease Progression
MH  - Eligibility Determination
MH  - Follow-Up Studies
MH  - Guideline Adherence/*standards/statistics & numerical data
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Netherlands
MH  - Practice Guidelines as Topic
MH  - Prostate/pathology
MH  - Prostate-Specific Antigen/blood
MH  - Prostatic Neoplasms/blood/diagnosis/pathology/*therapy
MH  - Risk Factors
MH  - Watchful Waiting/*standards/statistics & numerical data
OTO - NOTNLM
OT  - Active surveillance
OT  - Prostate cancer
OT  - Protocol adherence
EDAT- 2019/08/15 06:00
MHDA- 2020/06/20 06:00
CRDT- 2019/08/15 06:00
PHST- 2018/10/19 00:00 [received]
PHST- 2018/12/27 00:00 [revised]
PHST- 2019/01/08 00:00 [accepted]
PHST- 2019/08/15 06:00 [pubmed]
PHST- 2020/06/20 06:00 [medline]
PHST- 2019/08/15 06:00 [entrez]
AID - S2588-9311(19)30011-2 [pii]
AID - 10.1016/j.euo.2019.01.010 [doi]
PST - ppublish
SO  - Eur Urol Oncol. 2019 Sep;2(5):483-489. doi: 10.1016/j.euo.2019.01.010. Epub 2019 
      Feb 10.