Landmark studies

Oncology

Prostate Cancer

Prevention

• PCPT 2003 (Finasteride)
• SELECT 2009 (Selenium and Vitamin E)
• REDUCE 2010 (Dutasteride)

Screening

• PLCO 2008
• ERSPC 2009
• Goteburg 2010
• CAP 2018

Diagnosis and Evaluation

• MRI PROMIS 2017
• PRECISION 2018
• MRI-FIRST 2019
• ASIST 2019 (MRI in AS)
• STHLM3 NEJM 2021 (MRI-targetted vs. standard biopsy in prostate cancer screening)
• PET proPSMA 2020
• Goteborg-2 NEJM 2022 & 2024 (Systematic +/- targeted vs. targeted only prostate biopsy diagnosis and screening)

PSA and Other Markers

• Stamey et al. NEJM 1987
• Catalona et al. NEJM 1991
• Catalona et al. J Urol 1994 (PSA vs. DRE detection in screening)
• Catalona et al. 1998 (%fPSA)

Prostate Biopsy

• Antibiotic Prophylaxis in TRUS Biopsy of the Prostate Cochrane Review 2011
• Rates of hospital admission and mortality after TRUS-biopsy J Urol 2013

Management of Localized Disease

Observation vs. Treatment of Prostate Cancer

• PIVOT NEJM 2012
• SPCG-4 NEJM 2014
• PROTECT NEJM 2016

Active surveillance

• REDEEM Lancet 2012 (dutasteride in AS progression)

Radical prostatectomy

• Antibiotic prophylaxis at the time of catheter removal after radical prostatectomy

Radiation and ADT

• EORTC 22863 NEJM 1997 (EBRT +/- 3 years ADT)
• RTOG 86-10 (EBRT +/- 4 months ADT)
• RTOG 92-02
• EORTC 22961
• PR3/PR07
• SPCG-7/SFUO-3

Post-prostatectomy radiation

• Adjuvant vs. Observation
  • SWOG 8794
  • EORTC 22911
  • ARO 96-02
• ARTISTIC Lancet 2020 (meta-analysis of adjuvant vs. salvage)
• RADICALS Lancet 2020 (adjuvant vs. salvage)

Metastatic Hormone-Sensitive Prostate Cancer

• CHAARTED NEJM 2015 (docetaxel)
• STAMPEDE Lancet 2016 (docetaxel)
• STAMPEDE NEJM 2017 (abiraterone)
• LATITUDE NEJM 2017 (abiraterone)
• STAMPEDE Lancet 2018 (radiation)
• ENZAMET NEJM 2019 (enzalutamide)
• ARCHES JCO 2019 (enzalutamide)
• TITAN NEJM 2019 (enzalutamide)
• HERO NEJM 2020 (LHRH antagonist)

Castrate-Resistant Prostate Cancer

Non-metastatic

• ARAMIS NEJM 2018 (darolutamide)
• SPARTAN NEJM 2018 (apalutamide)
• PROSPER NEJM 2018 (enzalutamide)

Metastatic

Pre-docetaxel

• AFFIRM NEJM 2012 (enzalutamide)
• PREVAIL NEJM 2014 (enzalutamide)
• COU-AA-302
• TAX-327
• IMPACT

Post-docetaxel

• COU-AA-301
• VISION (177Lu-PSMA-617)
• PROfound NEJM 2020 (Olaparib)
• Denosumab vs. zoledronate
• TheraP (177Lu-PSMA-617 vs. cabazitaxel)
• ALSYMPCA (Radium-223)

Incidence of germline mutations in genes mediating DNA-repair processes in prostate cancer NEJM 2016

Kidney Cancer

• EORTC 30904 Partial vs. Radical Nephrectomy
• EORTC 30811 Eur Urol 2009 LND for cN0 suspected RCC

Cytoreductive nephrectomy

• SWOG 8949 IFN-α vs. CN + IFN-α vs.
• EORTC 30947 IFN-α vs. CN + IFN-α
• SURTIME JAMA Onc 2019 CN + sunitnib vs. sunitnib + CN
• CARMENA NEJM 2018 sunitnib vs. CN + sunitnib

Systemic treatment for metastatic disease

• CheckMate 214 NEJM 2018 (nivolumab + ipilimumab vs. sunitnib for untreated, advanced clear-cell RCC)
• CheckMate 9ER NEJM 2020 (nivolumab + cabozantinib vs. sunitnib for untreated, advanced clear-cell RCC)
• CLEAR NEJM 2021 (lenvatinib + pembrolizumab vs. lenvatinib + everolimus vs. sunitinib)

Adjuvant therapy after nephrectomy

• ASSURE Lancet 2016 (sunitnib vs. sorafenib)
• S-TRAC (sunitnib)
• KEYNOTE-564 (pembrolizumab)

Bladder Cancer

NMIBC

• Blue-light vs. white-light flexible cystoscopy in NMIBC surveillance 2018

Intravesical Therapy

Chemotherapy

• Meta-analysis of trials evaluating chemotherapy on risk of NMIBC recurrence 2013

BCG

• SWOG 8216/38 NEJM 1991 (BCG vs. doxorubicin BCG maintenance)
• SWOG 8507 J Urol 2000 (induction vs. induction + maintenance BCG)
• BCG and NMIBC Recurrence Cochrane Review 2000
• BCG and NMIBC Progression Meta-analaysis 2002
• BCG vs. MMC in NMIBC Cochrane Review 2003

BCG unresponsive NMIBC

• KEYNOTE-057 (pembrolizumab for BCG-unresponsive CIS)

MIBC

Neoadjuvant Chemotherapy

• SWOG 8710 NEJM 2003 (neoadjuvant MVAC)
• BA06 30894 JCO 2011 (neoadjuvant CMV)

Immunotherapy

• CheckMate 274 NEJM 2021 (adjuvant nivolumab)

Cystectomy

• RAZOR Lancet 2018 (robotic vs. open radical cystectomy)

Lymphadenectomy

• SWOG S1011 (standard vs. extended LND)
• LEA AUO AB 25/02 (limited vs. extended LND)

Systemic treatment for locally advanced, unresectable, or metastatic disease

• KEYNOTE-361 Lancet Onc 2021 (pembrolizumab + chemotherapy vs. chemotherapy alone vs. pembrolizumab alone)

Upper tract urothelial carcinoma

• Olympus Lancet Onc 2020 (UGN-101 for papillary UTUC)

Non-Oncology

Andrology

• Testosterone Deficiency
  • TEAAM (Testosterone's Effects on Atherosclerosis Progression in Aging Men) JAMA 2015
• Peyronie's Disease
  • IMPRESS I & 2 (Clostridial collagenase (Xiaflex) trials)

Functional

• MTOPS (combination alpha-blocker + 5ARI)
• CombAT (combination alpha-blocker + 5ARI)

Pediatrics

• RIVUR NEJM 2014 (antibiotic prophylaxis in VUR)

Other

• Mechanical Bowel Preparation for Elective Colorectal Surgery Cochrane Review 2011

Urogynecology and Reconstructive Pelvic Surgery

• Fecal Incontinence
  • CAPABLE (biofeedback vs loperamide for FI)
• Mixed Urinary Incontinence
  • ESTEEM (PT + Sling vs Sling alone)
• Pelvic Organ Prolapse
  • OPTIMAL/eOPTIMAL (SSLF vs USLS for apical prolapse; PMFT vs no intervention for associated urinary symptoms)
  • PESSRI (ring vs gelhorn pessary)
  • SUPeR/eSUPeR (vaginal mesh hysteropexy vs TVH/USLS for POP)
• Prolapse Associated Incontinence
  • CARE/eCARE (Burch + colpopexy vs colpopexy alone in women with preop SUI)
  • OPUS (Vaginal POP surgery + TVT vs vaginal POP surgery alone)
• Non-neurogenic Overactive Bladder
  • ABC (Anticholinergics vs Onabotulinum toxin A)
  • ORBIT (PTNS vs Tolterodine ER)
  • ROSETTA (Onabotulinum Toxin A 200u vs Interstim)
  • SUMiT/STEP (PTNS vs Sham; PTNS longitudinal single arm)
• Stress Urinary Incontinence
  • ATLAS (Continence pessary vs behavioral therapy vs Combined therapy)
  • SISTeR (Burch vs fascial sling)
  • TOMUS (retropubic vs. transobturator MUS)
  • VALUE (office eval vs preop UDS for preop eval of uncomplicated SUI and MUS outcomes)
• Other
  • Surgical Outcomes in Urogynecology-Assessment of Perioperative and Postoperative Complications Relative to Preoperative Hemoglobin A1c