II. Background
- Originally described here as Canadian protocol for Prostate Cancer active surveillance
- Has been studied for >15 years in the UK (ProtecT Trial) and US (PIVOT Trial)
- Has become a preferred option for management of low risk Prostate Cancer
III. Indications
- See Prostate Cancer Composite Risk for criteria
- Life Expectancy >15 years and
-
Prostate Cancer Very Low Risk of progression
- PSA <10 ng/ml
- Gleason <=6 (or Grading Group 1)
- Stage T2a or less
- Prostate biopsy with <3 cores positive for cancer, less than 50% of cores involved, and PSA density <0.15
IV. Efficacy
- Low risk Prostate Cancer mortality is 2.4% over 10 years
- Active surveillance mortality in low risk Prostate Cancer is as low as 0.8% over 10 years
- Avoids the risk of urinary, sexual and bowel dysfunction without significant increased mortality
V. Protocol: Surveillance
- PSA and Digital Rectal Exam
- Initial: Every 3 months for 2 years
- Later: Every 6 months
- Transrectal Ultrasound-guided biopsy with 10-12 core biopsies at one year and then every 3 years until age 80 years
- Consider transrectal Ultrasound on alternate exam dates
- Other measures include Multiparametric MRI and biomarkers (see Prostate Cancer)
VI. Protocol: Intervention indications
- PSA doubling time <3 years based on =8 values
- Gleason Score progresses to =7