Dr. med. Dirk Manski

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Prostate Cancer: Active Surveillance


Guidelines and review literature: (EAU Guidelines Prostate Cancer) (S3-Leitlinie Prostatakarzinom der DGU) (Walsh-Campbell Urology).

Active Surveillance in Prostate Cancer

Active surveillance is an option for a small, well-differentiated prostate cancer and if the patient wishes a deferred treatment to avoid side effects of curative therapy. If, during active surveillance, a progression of the tumor occurs, curative treatment such as radical prostatectomy or radiotherapy is initiated. Several risk assessments and monitoring protocols exist to detect clinically significant prostate cancer and to trigger active treatment. The clinical controls include, depending on the protocol and age of the patient, digital-rectal examinations, PSA, mpMRI of the prostate, and prostate biopsies. The following monitoring protocol is recommended in the guideline for prostate cancer of the DGU:

Inclusion Criteria for Active Surveillance:

A prostate biopsy of good quality is a prerequisite for the assessment of tumor stage. Ideally, an mpMRI of the prostate is used for additional targeted biopsy of suspicious areas. There should be at least 8 biopsy cores, and 10 to 12 cores if the prostate volume is over 40 ml. The following criteria should be met:

Follow-up of Active Surveillance:

First, quarterly, after two years, then half-yearly checks with PSA testing. Perform digital-rectal examination every six months. A control prostate needle biopsy is recommended after 6 months, further controls are done every 12–18 months. After three years of stable disease, biopsies are repeated every three years.

Abort Criteria for Active Surveillance:

Active surveillance ends and curative therapy is recommended if the inclusion criteria are no longer met or if the PSA doubling time is below three years. If life expectancy is less than ten years at the time of abortion, watchful waiting is also an option, and hormone therapy is started if symptoms or rapid progression occurs.

Results of Active Surveillance:

In a series of nearly 1000 patients, 76% (5 years follow-up), 64% (10 years follow-up), and 55% (15 years follow-up) of patients met the criteria of active surveillance and were not treated. 1.5% of patients died of prostate cancer and 2.8% developed bone metastases (Klotz et al., 2015). These results are comparable to curative therapy in low-risk patients. The randomized Protect trial (active surveillance vs. immediate curative treatment) showed minor differences (6% vs. 2%) in the overall low rate of metastasis at ten years. 55% of patients with active surveillance experienced disease progression and had delayed curative therapy (Hamdy et al., 2016).

The adjuvant therapy with the 5α reductase inhibitor dutasteride could further improve these results. In a series of 302 men, 38% (with dutasteride) and 48% (with placebo) progressed under active surveillance within a three-year period (Fleschner et al., 2012).

Results of Conservative Therapy (Watchful Waiting):

Active surveillance has been developed from watchful waiting, which showed good results in good differentiated tumors. In contrast to active surveillance, conservative treatment (watchful waiting) abstains from active treatment if progress occurs in patients. Hormone therapy is started in case of significant PSA progression (PSA above 50 ng/ml or a PSA doubling time under twelve months) or symptomatic progression of prostate carcinoma (Studer et al., 2008).

Conservative treatment leads within 10–15 years to relevant cancer-specific mortality, especially in poorly differentiated tumors. For well-differentiated tumors, the results are favorable. For retrospective results of conservative therapy, see table conservative treatment results of prostate cancer.

Results of conservative treatment of prostate cancer (watchful waiting): survival of patients with prostate cancer, age of the patients with diagnosis 55–69 years, follow-up 15 years, retrospective, n=767: for the Gleason score 2–4, 5, 6, 7, and 8–10 there is a risk of 4–6%, 6–10%, 18–27%, 70–53%, 87–72% to die from prostate cancer. The number ranges indicate the age-dependent variability; the first number applies to the group of patients 55–59 years old (age at diagnosis), the second number for the patient group 65–69 years (age at diagnosis), the patients 60–64 years old at diagnosis are in between (Albertsen et al., 1998).
Gleason- Summe Overall Survival (%) Non-cancer Mortality (%) Cancer-specific Mortality (%)
2–4 69–38 27–56 4–6
5 67–36 27–55 6–10
6 57–25 25–48 18–27
7 15–11 15–36 70–53
8–10 3 10–25 87–72







Index: 1–9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

References

Albertsen u.a. 1998 ALBERTSEN, P. C. ; HANLEY, J. A. ; GLEASON, D. F. ; BARRY, M. J.: Competing risk analysis of men aged 55 to 74 years at diagnosis managed conservatively for clinically localized prostate cancer.
In: Jama
280 (1998), Nr. 11, S. 975–80

M. A. Dall'Era, M. R. Cooperberg, J. M. Chan, B. J. Davies, P. C. Albertsen, L. H. Klotz, C. A. Warlick, L. Holmberg, D. E. Bailey, M. E. Wallace, P. W. Kantoff, and P. R. Carroll. Active surveillance for early-stage prostate cancer: review of the current literature.
Cancer, 112 (8): 1650–1659, Apr 2008.
doi: rm10.1002/cncr.23373.
URL https://dx.doi.org/10.1002/cncr.23373.

EAU Guidelines EAU - EANM - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer, https://uroweb.org/guidelines/prostate-cancer/.


Fleshner, N. E.; Lucia, M. S.; Egerdie, B.; Aaron, L.; Eure, G.; Nandy, I.; Black, L. & Rittmaster, R. S. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial.
Lancet, 2012, 379, 1103-1111.

Hamdy, F. C.; Donovan, J. L.; Lane, J. A.; Mason, M.; Metcalfe, C.; Holding, P.; Davis, M.; Peters, T. J.; Turner, E. L.; Martin, R. M.; Oxley, J.; Robinson, M.; Staffurth, J.; Walsh, E.; Bollina, P.; Catto, J.; Doble, A.; Doherty, A.; Gillatt, D.; Kockelbergh, R.; Kynaston, H.; Paul, A.; Powell, P.; Prescott, S.; Rosario, D. J.; Rowe, E.; Neal, D. E. & Group, P. S. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer.
The New England journal of medicine, 2016, 375, 1415-1424



A. Heidenreich, G. Aus, M. Bolla, S. Joniau, V. B. Matveev, H. P. Schmid, F. Zattoni, and E. A. of Urology. Eau guidelines on prostate cancer.
Eur Urol, 53 (1): 68–80, Jan 2008.

Klotz, L.; Vesprini, D.; Sethukavalan, P.; Jethava, V.; Zhang, L.; Jain, S.; Yamamoto, T.; Mamedov, A. & Loblaw, A. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer.
J Clin Oncol, 2015, 33, 272-277.

Leyh-Bannurah, S.-R.; Gazdovich, S.; Budäus, L.; Zaffuto, E.; Briganti, A.; Abdollah, F.; Montorsi, F.; Schiffmann, J.; Menon, M.; Shariat, S. F.; Fisch, M.; Chun, F.; Steuber, T.; Huland, H.; Graefen, M. & Karakiewicz, P. I. Local Therapy Improves Survival in Metastatic Prostate Cancer.
European urology, 2017, 72, 118-124

Leitlinienprogramm Onkologie (DGU, Deutsche Krebsgesellschaft, Deutsche Krebshilfe): Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms https://www.leitlinienprogramm-onkologie.de/leitlinien/prostatakarzinom/ Albertsen u.a. 1998 ALBERTSEN, P. C. ; HANLEY, J. A. ; GLEASON, D. F. ; BARRY, M. J.: Competing risk analysis of men aged 55 to 74 years at diagnosis managed conservatively for clinically localized prostate cancer.
In: Jama
280 (1998), Nr. 11, S. 975–80

M. A. Dall'Era, M. R. Cooperberg, J. M. Chan, B. J. Davies, P. C. Albertsen, L. H. Klotz, C. A. Warlick, L. Holmberg, D. E. Bailey, M. E. Wallace, P. W. Kantoff, and P. R. Carroll. Active surveillance for early-stage prostate cancer: review of the current literature.
Cancer, 112 (8): 1650–1659, Apr 2008.
doi: rm10.1002/cncr.23373.
URL https://dx.doi.org/10.1002/cncr.23373.

Fleshner, N. E.; Lucia, M. S.; Egerdie, B.; Aaron, L.; Eure, G.; Nandy, I.; Black, L. & Rittmaster, R. S. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial.
Lancet, 2012, 379, 1103-1111.

Hamdy, F. C.; Donovan, J. L.; Lane, J. A.; Mason, M.; Metcalfe, C.; Holding, P.; Davis, M.; Peters, T. J.; Turner, E. L.; Martin, R. M.; Oxley, J.; Robinson, M.; Staffurth, J.; Walsh, E.; Bollina, P.; Catto, J.; Doble, A.; Doherty, A.; Gillatt, D.; Kockelbergh, R.; Kynaston, H.; Paul, A.; Powell, P.; Prescott, S.; Rosario, D. J.; Rowe, E.; Neal, D. E. & Group, P. S. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer.
The New England journal of medicine, 2016, 375, 1415-1424

N. Mottet (Chair), J. Bellmunt, E. Briers (Patient Representative), R.C.N. van den Bergh (Guidelines Associate), M. Bolla, N.J. van Casteren (Guidelines Associate), P. Cornford, S. Culine, S. Joniau, T. Lam, M.D. Mason, V. Matveev, H. van der Poel, T.H. van der Kwast, O. Rouvière, T. Wiegel Guidelines on Prostate Cancer of the European Association of Urology (EAU), https://uroweb.org/guidelines/prostate-cancer/.



Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF): Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms, Langversion 3.1, 2014 AWMF Registernummer: 034/022OL, https://www.awmf.org//leitlinien/detail/ll/043-022OL.html (Zugriff am: 07.02.2016)

Leyh-Bannurah, S.-R.; Gazdovich, S.; Budäus, L.; Zaffuto, E.; Briganti, A.; Abdollah, F.; Montorsi, F.; Schiffmann, J.; Menon, M.; Shariat, S. F.; Fisch, M.; Chun, F.; Steuber, T.; Huland, H.; Graefen, M. & Karakiewicz, P. I. Local Therapy Improves Survival in Metastatic Prostate Cancer.
European urology, 2017, 72, 118-124

Parker, C. C.; James, N. D.; Brawley, C. D.; Clarke, N. W.; Hoyle, A. P.; Ali, A.; Ritchie, A. W. S.; Attard, G.; Chowdhury, S.; Cross, W.; Dearnaley, D. P.; Gillessen, S.; Gilson, C.; Jones, R. J.; Langley, R. E.; Malik, Z. I.; Mason, M. D.; Matheson, D.; Millman, R.; Russell, J. M.; Thalmann, G. N.; Amos, C. L.; Alonzi, R.; Bahl, A.; Birtle, A.; Din, O.; Douis, H.; Eswar, C.; Gale, J.; Gannon, M. R.; Jonnada, S.; Khaksar, S.; Lester, J. F.; O'Sullivan, J. M.; Parikh, O. A.; Pedley, I. D.; Pudney, D. M.; Sheehan, D. J.; Srihari, N. N.; Tran, A. T. H.; Parmar, M. K. B.; Sydes, M. R. & for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators, S. T. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial.
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Wein, A. J.; Kavoussi, L. R.; Partin, A. P. & Peters, C. A. Campbell-Walsh Urology
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Studer, U. E.; Collette, L.; Whelan, P.; Albrecht, W.; Casselman, J.; de Reijke, T.; Knönagel, H.; Loidl, W.; Isorna, S.; Sundaram, S. K.; Debois, M. & , E. O. R. T. C. G. G. Using PSA to guide timing of androgen deprivation in patients with T0-4 N0-2 M0 prostate cancer not suitable for local curative treatment (EORTC 30891).
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Tosoian, J. J.; Trock, B. J.; Landis, P.; Feng, Z.; Epstein, J. I.; Partin, A. W.; Walsh, P. C. & Carter, H. B. Active surveillance program for prostate cancer: an update of the Johns Hopkins experience.
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Wilt, T. J.; Brawer, M. K.; Jones, K. M.; Barry, M. J.; Aronson, W. J.; Fox, S.; Gingrich, J. R.; Wei, J. T.; Gilhooly, P.; Grob, B. M.; Nsouli, I.; Iyer, P.; Cartagena, R.; Snider, G.; Roehrborn, C.; Sharifi, R.; Blank, W.; Pandya, P.; Andriole, G. L.; Culkin, D.; Wheeler, T. & PIVOT Study Group Radical prostatectomy versus observation for localized prostate cancer.
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Wilt, T. J.; Jones, K. M.; Barry, M. J.; Andriole, G. L.; Culkin, D.; Wheeler, T.; Aronson, W. J. & Brawer, M. K. Follow-up of Prostatectomy versus Observation for Early Prostate Cancer.
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