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Authors: Warde PR et al, ASCO 2010 Abstract: CRA4504 Reviewed by: Dr. Lori Wood

Intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP), (NCIC-CTG PR.3). Authors: Warde PR et al, ASCO 2010 Abstract: CRA4504 Reviewed by: Dr. Lori Wood Date posted: Jun 18 2010.

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Authors: Warde PR et al, ASCO 2010 Abstract: CRA4504 Reviewed by: Dr. Lori Wood

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  1. Intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP), (NCIC-CTG PR.3) Authors: Warde PR et al, ASCO 2010 Abstract: CRA4504 Reviewed by: Dr. Lori Wood Date posted: Jun 18 2010

  2. Thank you for downloading this update. Please feel free to use it for educational purposes. Please acknowledge OncologyEducation.ca and Dr. Wood when using these slides.

  3. STUDY DESIGN Treatment A: Androgen Deprivation Therapy (ADT) (Orchiectomy or LHRHa Continuous) N=602 R Treatment B: ADT plus: Radiation (45 Gy/25 # to Pelvis and 20-24 Gy/10-12 # to Prostate) N=603 • High-risk, localized PCa • - predominately T3/T4 • - Primary outcome: • - overall survival • Statistics: • - N=1200 • - Goal: 10% improvement • with target HR 0.76

  4. Designed in 1993 Emerging data: RT alone in high-risk prostate cancer was disappointing Addition of ADT improvedresults It was unclear if the benefit was from ADT and what the added benefit of local RT was MRC PR02 (1992) RT vs. orchiectomy vs. combination Closed due to poor accrual No evidence of survival benefit with RT Therefore the question was: Does local RT in addition to ADT improve OS in high-risk localized prostate cancer? STUDY RATIONALE

  5. RESULTS • Results from second planned interim analysis with median follow-up of 6 years

  6. STUDY COMMENTARY • The addition of radiation therapy to ADT in high-risk prostate cancer •  overall survival (74% vs. 66% at 7 years) •  disease specific survival (90% vs. 79% at 7 years) • No significant increase in late toxicity • Relevance to 2010 • Capcure Database showed a significant amount of ADT was used alone as primary therapy • 1990-1994: 36.7% • 2004-2007: 45.5% • Significant variation in current therapy • In these high risk patients, ADT and RT should be considered standard of care and not ADT alone

  7. BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Canadian led study • If non-surgical option chosen which is the case in most high-risk patients, the standard of care should be the combination of ADT and RT • However: • The survival benefit may not be seen until after ~ 4 years which needs to be taken into account in patients who have other significant co-morbidities • There are toxicities of ADT and RT that need to be taken into account • Optimal duration of ADT still unknown • Unknown if there would be an even greater benefit of RT if given with current RT doses (vs. those in 1995)

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