Eleven-year management of prostate cancer patients on active surveillance: What have we learned?

Cristina Marenghi, Maria Francesca Alvisi, Federica Palorini, Barbara Avuzzi, Fabio Badenchini, Nice Bedini, Lara Bellardita, Davide Biasoni, Davide Bosetti, Alessandra Casale, Mario Catanzaro, Maurizio Colecchia, Letizia De Luca, Simona Donegani, Paola Dordoni, Rodolfo Lanocita, Massimo Maffezzini, Tiziana Magnani, Julia Menichetti, Antonella MessinaSara Morlino, Biagio Paolini, Tiziana Rancati, Silvia Stagni, Antonio Tesone, Tullio Torelli, Edoardo Tulli Baldoin, Marta Vaiani, Sergio Villa, Silvia Villa, Nadia Zaffaroni, Nicola Nicolai, Roberto Salvioni, Riccardo Valdagni

Research output: Contribution to journalArticlepeer-review


Purpose: To evaluate the outcomes of active surveillance (AS) on patients with low-risk prostate cancer (PCa) and to identify predictors of disease reclassification. Methods: In 2005, we defined an institutional AS protocol (Sorveglianza Attiva Istituto Nazionale Tumori [SAINT]), and we joined the Prostate Cancer Research International: Active Surveillance (PRIAS) study in 2007. Eligibility criteria included clinical stage ≤T2a, initial prostate-specific antigen (PSA) <10 ng/mL, and Gleason Pattern Score (GPS) ≤3 + 3 (both protocols); ≤25% positive cores with a maximum core length containing cancer ≤50% (SAINT); and ≤2 positive cores and PSA density <0.2 ng/mL/cm3 (PRIAS). Switching to active treatment was advised for a worsening of GPS, increased positive cores, or PSA doubling time <3 years. Active treatment-free survival (ATFS) was assessed using the Kaplan-Meier method. Factors associated with ATFS were evaluated with a multivariate Cox proportional hazards model. Results: A total of 818 patients were included: 200 in SAINT, 530 in PRIAS, and 88 in personalized AS monitoring. Active treatment-free survival was 50% after a median follow-up of 60 months. A total of 404/818 patients (49.4%) discontinued AS: 274 for biopsy-related reclassification, 121/404 (30%) for off-protocol reasons, 9/404 (2.2%) because of anxiety. Biopsy reclassification was associated with PSA density (hazard ratio [HR] 1.8), maximum percentage of core involvement (HR 1.5), positive cores at diagnostic biopsy (HR 1.6), older age (HR 1.5), and prostate volume (HR 0.6) (all p<0.01). Patients from SAINT were significantly more likely to discontinue AS than were the patients from PRIAS (HR 1.65, p<0.0001). Conclusions: Five years after diagnosis, 50% of patients with early PCa were spared from active treatment. Wide inclusion criteria are associated with lower ATFS. However, at preliminary analysis, this does not seem to affect the probability of unfavorable pathology.

Original languageEnglish
Pages (from-to)464-474
Number of pages11
Issue number5
Publication statusPublished - Sep 1 2017


  • Active surveillance
  • Active treatment-free survival
  • Low-risk prostate cancer
  • Outcomes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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