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NCCN Flash Updates™: NCCN Guidelines® & NCCN Compendium® Updated

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Prostate Cancer. These NCCN Guidelines® are currently available as Version 1.2016.

  • Initial Prostate Cancer Diagnosis (PROS-1)
    • Footnote “b” modified to: “Men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups. These include, but are not limited to, likelihood of death with conservative management, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. See Discussion section.”


  • Intermediate Risk Group (PROS-4)
    • Added a new footnote for patients with favorable intermediate-risk prostate cancer, “Patients with favorable intermediate-risk prostate cancer (predominant Gleason grade 3 [i.e., Gleason score 3 + 4 = 7], and percentage of positive biopsy cores < 50 percent, and no more than one NCCN intermediate risk factor) can be considered for active surveillance. See Discussion section.”
    • Modified an existing footnote “Active surveillance of unfavorable intermediate and high-risk clinically localized cancers is not recommended in patients with a life expectancy >10 years (category 1).”
  • High- and Very High-Risk Groups  (PROS-5)
    • “EBRT +  ADT (2-3 y) + docetaxel” was added as an initial therapy option for high- and very high-risk groups with the following footnote: “Addition of 6 cycles of docetaxel every 3 weeks without prednisone administered following the completion of radiation.”
  • Radical Prostatectomy Biochemical Failure (PROS-7), Radiation Therapy Recurrence (PROS-8), and Systemic Therapy For Progressive Castration-Naive Disease (PROS-9)
    • Footnote “t” modified to: “Observation involves monitoring the course of disease with the expectation to begin ADT when symptoms develop or PSA changes to suggest symptoms are imminent. See Principles of Active Surveillance and Observation (PROS-C).”


  • Radiation Therapy Recurrence (PROS-8)
    • Following candidate for local therapy:
      • Changed the recommendation for TRUS biopsy to “Consider TRUS biopsy.”
      • If TRUS biopsy positive, studies negative for distant metastases: added pelvic lymph node dissection (PLND) to radical prostatectomy (RP) recommendation.
  • Systemic Therapy For Progressive Castration-Naive Disease (PROS-9)
    • Separated treatment options for M0 and M1 disease.
    • Added a new footnote stating, “Intermittent ADT can be considered for men with M0 or M1 disease to reduce toxicity. See Principles of Androgen Deprivation Therapy (PROS-F).”
    • M1 disease, modified the treatment option to read: “Continuous ADT and docetaxel 75 mg/m2 with or without prednisone for 6 cycles.”
    • Modified footnote “u” by adding “Patients with low volume disease have less certain benefit from early treatment with docetaxel combined with ADT.”
    • Following small cell, changed treatment option “docetaxel-based regimen” to “docetaxel/carboplatin.”


  • Systemic Therapy for M0 CRPC (PROS-10), Systemic Therapy for M1 CRPC (PROS-11), and Subsequent Systemic Therapy for M1 CRPC (PROS-12 and PROS-13)
    • Ketoconazole, added “± hydrocortisone.” This change was made throughout the guideline where ketoconazole is recommended.
    • DES or other estrogen, added the following footnote: “DES has cardiovascular and thromboembolic side effects at any dose but frequency is dose and agent dependent. DES should be initiated at 1 mg/day and increased, if necessary, to achieve castrate levels of serum testosterone (<50 ng/dL). Other estrogens delivered topically or parenterally may have less frequent side effects but data are limited.” This change was made throughout the guideline where DES or other estrogen is recommended.
  • Principles of Imaging (PROS-B)
    • Modified the following bullet  “Newer technology using 18F-NaF as the tracer for a PET scan or hybrid imaging bones scans can be used as a diagnostic staging study. These tests appear to have greater sensitivity than bone scan. However, there is controversy about how the results of 18F-NaF PET bone scan should be acted upon since all phase 3 clinical trials to date have used progression criteria on bone scans.
    • Modified the following bullet: “MRI may be considered in patients after RP when PSA fails to fall to undetectable levels or when an undetectable PSA becomes detectable and increases on 2 or more subsequent determinations, or after RT for rising PSA or positive DRE if the patient is a candidate for additional local therapy. MRI-US fusion biopsy may improve the detection of higher grade (Gleason score >7) cancers.”
  • Principles of Active Surveillance and Observation (PROS-C, 2 of 2)
    • Added the following bullet under Advantages of active surveillance:
      • About 2/3 of men eligible for active surveillance will avoid treatment.
    • Added the following bullets under Disadvantages of active surveillance
      • About 1/3 of men will require treatment, although treatment delays do not seem to impact cure rate.
      • Periodic follow-up prostate biopsies may be necessary.
    • Removed the following bullets under Disadvantages of active surveillance:
      • Risk of progression and/or metastases
      • Subsequent treatment may be more complex with increased side effects
      • Nerve sparing may be more difficult, which may reduce chance of potency preservation after surgery
      • Increased anxiety
      • Requires frequent medical exams and periodic biopsies, which are not without complications
      • Uncertain long-term natural history of prostate cancer
  • Principles of Radiation Therapy (PROS-D)
    • Primary external beam radiation therapy: modified the statement “Patients with high-risk and very high-risk cancers should receive neoadjuvant/concomitant/adjuvant ADT for a total of 2 to 3 y if comorbidities allow (category 1). Pelvic lymph node irradiation can be considered.
    • Primary brachytherapy: modified the statement “Patients with a very large prostate or very small prostate, symptoms of bladder outlet obstruction (high IPSS), or a previous transurethral resection of the prostate are more difficult to implant and may suffer increased risk of side effects. Neoadjuvant ADT may be used to shrink the prostate to an acceptable size; however, increased toxicity would be expected from ADT and prostate size may not decline in some men despite neoadjuvant ADT. Potential toxicity of ADT must be balanced against the potential benefit of target reduction.


  • Principles of Immunotherapy and Chemotherapy (PROS-G)
    • Added 2 new bullets:
      • “Men who have not demonstrated definitive evidence of progression on prior docetaxel therapy, may be retreated with docetaxel.” 
      • “No chemotherapy regimen to date has demonstrated improved survival or quality of life after cabazitaxel, and participation in clinical trials should be encouraged.”

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