Low Risk

Updated 29 July 2009

Low Risk (all of the following):

  • PSA <=10 ng/mL
  • Gleason <=6
  • Stage T1/T2b (2002 TNM)

Management

Patients with low risk cancer have 10-year prostate cancer survival rates in excess of 99% [1, 2], and it is uncertain if intervention improves longer term survival. For this reason the option of active surveillance should always be considered (see below) as a means of avoiding over-treatment which may otherwise occur in over 50% of men with PSA screen-detected cancer [3] [4]. However, as a substantial number of men who are thought to have low risk cancer on sextant biopsy will be found to have more significant cancer if they undertake prostatectomy, it is essential to carefully consider all available diagnostic and clinical information before embarking on a surveillance strategy. For these reasons a protocol for Active Surveillance has been developed to permit the careful management of men with low and minimal risk prostate cancer.

Active Surveillance Protocol for the Management of Patients with Low Risk Prostate Cancer:

Patients with low risk prostate cancer (PSA<=10, T stage <=2, Gleason score <=3+3=6/10) are eligible. Additionally, men with low risk cancers whose PSA is up to 15 will also be considered, as long as the PSA density is <0.2 ng/ml/cc. Patients will be counselled as to the option of Active Surveillance, as well as immediate intervention.

Active Surveillance Protocol Schedule

Re-biopsy upon entry (within 3 months) 8-12 biopsy cores, the greater number being in those with larger prostate glands,[5] unless the initial biopsy was considered adequate. The specimen will be reviewed by a reference pathologist. The specimen will be centrally stored for possible future analysis.

  • PSA (& serum may be frozen and stored for selected patients), every 3 months for 2 years then 6 monthly
  • DRE every 6 months for 2 years then annually
  • Re-biopsy every 3 years, unless indicated earlier. Re-biopsy if PSA doubling time >3 and <10 years), but no more than 1 biopsy per year
  • Annual re-evaluation point for continuation of Active Surveillance.

Indications to exit the program and consider intervention

  • PSADT (based on minimum 3 values) faster than 3 years
  • Appearance of primary or secondary Gleason 4 or any Gleason 5 pattern on re-biopsy
  • Clinical stage progression to T3
  • Patient choice

Treatment Options

  1. Radical prostatectomy with or without pelvic lymph node dissection
    1. Node dissection may not be necessary in low risk disease
    2. Positive pelvic nodes at exploration are an indicator of disseminated disease. Radical prostatectomy is not indicated in the presence of grossly positive pelvic lymph nodes and early androgen suppression therapy is indicated. In some patients with microscopic disease in lymph nodes, radical prostatectomy may be completed. This situation should be clarified with the patient prior to surgery
    3. A nerve sparing procedure should be avoided on the side of the lesion (T2a) or with significant apical disease. Neoadjuvant androgen withdrawal therapy reduces the risk of positive margins by 50%, but since the effects on recurrence rates are not yet known, it should not be routinely employed off study
  2. Radical Radiotherapy
    1. External beam radiation. Patients with a bulky primary tumour may additionally benefit from neoadjuvant androgen ablation (see high risk section)
    2. Brachytherapy
      Prostate Brachytherapy is a standard treatment for early stage, localized prostate cancer. The Provincial Prostate Brachytherapy Program was established 11 years ago. Within the BCCA umbrella, over 2,500 patients have been implanted using common selection criteria, treatment algorithms, and quality control. The procedure is done using a real-time ultrasound guidance and fluoroscopy, as originally developed by the Seattle group, 20 years ago. Most implants are done with general or spinal anaesthesia, all as a day-care procedure, over a period of 1 hour. Most men return to their usual daily activity within days after the procedure

References:

  1. Pickles, T. and Prostate Cohort Outcomes Initiative. Low risk prostate cancer carries a minimal risk of prostate mortality and intensification of treatment should be questioned. ASCO-ASTRO Prostate Symposium. 2006.

  2. Murthy, V., et al., Recovery of serum testosterone after neoadjuvant androgen deprivation therapy and radical radiotherapy in localized prostate cancer. BJU Int, 2006. 97(3): p. 476-9.

  3. Draisma, G., et al., Lead times and overdetection due to prostate-specific antigen screening: estimates from the European Randomized Study of Screening for Prostate Cancer. J Natl Cancer Inst, 2003. 95(12): p. 868-78.

  4. Klotz, L., Active surveillance with selective delayed intervention for favorable risk prostate cancer. Urol Oncol, 2006. 24(1): p. 46-50.

  5. Vashi, A.R., et al., A model for the number of cores per prostate biopsy based on patient age and prostate gland volume. J Urol, 1998. 159(3): p. 920-4.