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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:

Clinical stage cT1 or cT2a
PSA < 10 ng/ml
Prostate biopsy with a maximum of two tumor-bearing cores, maximum of 50% tumor infiltration of a single core, and Gleason score <7
Some protocols also accept patients with Gleason score 7a (3 + 4) if the tumor infiltration is less than 33% in the respective core and the longest tumor length is below 5 mm.

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

Prostate cancer treatment options

Index

Prostate cancer prostatectomy

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

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