Active Surveillance is acceptable for for high-risk

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Congestive heart failure, diabetes with end organ dysfunction. • Charlson co-morbidity index. This man was treated with combination XRT/brachy, and Androgen ...

SURE:  Active Surveillance is  acceptable for for high‐risk  prostate cancer  (be nuanced) Viraj Master MD PhD FACS Professor Department of Urology Emory University

What is high risk prostate cancer,  really? • We are still using a definition (essentially)  unchanged since 1999 • A. V. D’Amico • Used end point of PSA failure (really, is  this worthwhile?) • Clinical T stage ≥cT2c  • Gleason score ≥8,  • PSA >20 ng/ml  • Still the AUA definition

Common definitions of high‐risk  prostate cancer

Other definitions of high risk • RTOG – – – –

Gleason score ≥8  or Gleason score 7 plus either ≥cT3  or node‐positive disease;  PSA adds little to this model for the prediction of cause‐ specific survival or overall survival 

• NCCN – – – –

T3a  Gleason ≥8  PSA ≥20 ng/ml  ‘very high risk’ as T3b or T4 disease 

Not all patients with prostate cancer  produce the same level of PSA • ~350 patient study of Black and White men • Benign prostate tissue produces equal  amounts of PSA in Black and White men • BUT, Gleason score 3+3=6 (Grade Group 1)  prostate cancer produces less PSA in Black  men

Case • • • •

66 yo man no comorbid conditions PSA 22 GG 3+4 = 7 cT1c (no palpable disease)

Case…nuances • • • •

66 yo man no comorbid conditions PSA 22 GG 3+4 = 7 cT1c (no palpable disease)

• 150gm prostate • PSA in 2011 was 23

Case…nuances • 66 yo man no comorbid  • 7 previous negative  conditions biopsies (2000‐2015) • PSA 22 • GG 7 disease found   • GG 3+4 = 7 • cT1c (no palpable  disease) • 150gm prostate • PSA in 2011 was 23

Sorting out the bad actors

Case 2 • 70 yo • PSA 9.4, cT1c, Gleason 8 • Congestive heart failure, diabetes with end organ  dysfunction • Charlson co‐morbidity index

This man was treated with combination XRT/brachy,  and Androgen deprivation therapy

Conclusion of the Case • Patient has intractable hematuria 2 years after  therapy.  • Multiple hospitalizations • Transfusions • Died of bleeding‐related complications 

Emory-Harvard-University of Washington Prostate Cancer Biomarker Center (an EDRN CVC) AIM 2b

Elevated PSA or Suspicious DRE


Primary/ Local Treatment


AIM 1: Combine  serum phi with  urine PCA3/T2Erg

Diagnostic/ Index Prostate Biopsy

Definitive Treatment

C Regional/Systemic Therapy

B Active Surveillance


AIM 2a PET Imaging Biopsy Tissue

HYPOTHESIS: early detection targeting aggressive prostate cancer, will enhance survival benefit of treating lethal disease yet reduce harms of over-treating indolent Pca AIMS: • • •

Validate combining phi, PCA3, T2Erg to predict biopsy (PCA3 Trial) and AS progression-PASS Validate multiplex RNA signatures (tissue, urine) to discern aggressive PCa (PASS, URS) FACBC-PET to detect occult metastatic in high risk primary prostate cancer

INVESTIGATORS: Emory: Sanda (PI), Huang (co-PI), Moreno, Schuster, Goodman, Alemozaffar, Petros, Pellegrini; Harvard SPH: Mucci; Univ Washington: Lin (PASS)

Conclusions The literature is limited: consequence of variations in definition  lack of prospective randomized trials limitations in statistical plan (underpowered  studies)  • the need for long‐term follow‐up,  • suboptimal end points  • Treating the entire patient • • • •

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