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Organ confined prostate cancer

Management of organ confined prostate cancer requires an individualised assessment of the risk of prostate cancer mortality relative to other competing risks for death over time (Campbell’s).

What are the treatment options in an otherwise healthy man with localised prostate cancer?

  1. Active surveillance
  2. Radical prostatectomy
  3. External beam radiation therapy
  4. Brachytherapy
  5. Focal therapy
  6. Watchful waiting

 

 

Trials in active management of organ confined prostate cancer:

SPCG-4 (Scandinavian Prostate Cancer Group):

  • RCT – watchful waiting vs radical prostatectomy
  • Pre-PSA era: nearly 90 % of patients had palpable disease
  • Overall survival and prostate cancer specific survival better in men treated with RP
    • NNT 8 to prevent 1 death
    • Prostate cancer specific survival benefit more pronounced in men < 65 and Gleason 7+
  • Not applicable to current patients – pre-PSA screening era, palpable disease

 

PIVOT (Prostate Cancer Intervention Versus Observation Trial):

  • RCT – observation vs radical prostatectomy
  • 731 men recruited (were aiming for 2000) between 1994 – 2002 in USA
    • Nearly 20 % of these were then non-adherent to treatment arm
    • Only 10 % were aged under 60
    • After 10 years, nearly 40 % of patients had died (only about 5 % from prostate cancer)
  • At 10 years, no difference in overall survival or prostate cancer specific survival
    • But survival benefit for men with PSA > 10, Gleason 7+, and reduction in bone metastases
  • At 19 years, overall mortality 66 vs 61 % in favour of RP, prostate cancer specific mortality 11 vs 7 % in favour of treatment
    • 14 % absolute overall mortality reduction for RP if Gleason 7+

 

ProtecT (Prostate Testing for Cancer and Treatment):

  • RCT – active PSA monitoring vs radical prostatectomy vs XRT (with 3-6 months ADT)
  • 1643 men randomised – 62 % accepted randomisation
    • 77 % of patients Gleason 6 with low PSA
  • 88, 71 and 74% of men assigned to monitoring, RP and XRT underwent that plan
  • Of those monitored – a quarter were treated within 3 years, half treated within 10 years
  • At 10 years
    • No difference in prostate cancer specific survival
    • Higher rate of metastases in monitoring group
    • Overall prostate cancer mortality 1 %
  • 15 year update (2023)
    • Still no difference in prostate cancer specific or overall survival
    • Prostate cancer specific mortality 3-4 %
    • Higher metastases in monitoring group
    • 61 % of those assigned to monitoring now have had radical treatment

 

? Are these trials useful with contemporary cohorts – active surveillance, MRI, targeted biopsies