Routine monitoring of prostate specific antigen detects prostate cancer at a very early stage. After 12 years of follow of patients in the Prostate Cancer Intervention versus Observation Trial (PIVOT), radical prostatectomy did not improve cancer related mortality in patients with localized PCa (Wilt et al., 2012). Extensive utilization of PSA screening leads to detection of low volume, non-palpable tumors (National institute of health [NIH], 2011). This stage migration necessitates alternate management strategies. Aggressive management of slow- growing PCa with radiation or surgery also carries the risk of short term and long term complications such as erectile dysfunction and incontinence. Active surveillance (AS) is a management option for patients with low risk prostate cancer to reduce treatment related cost and morbidity.
AS and watchful waiting (WW) are two observational strategies for management of PCa. WW may be the appropriate strategy for elderly patients with multiple comorbidities. In WW, curative management is omitted and they receive palliative androgen therapy when symptoms arise (Klotz, 2012; NIH, 2011). AS is the management strategy for patients with indolent PCa in which there is close follow up using certain indicators to detect disease progression and to initiate curative intervention when patients get reclassified as having clinically significant PCa (Klotz, 2012; NIH, 2011). Determinants of active surveillance are eligibility criteria, protocol for disease monitoring, and indicators for curative treatment (NIH, 2011).
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Eligibility Criteria Men with clinically insignificant PCa are at low risk for complications and are candidates for active surveillance. Identification of such patients is challenging. Though there are no universal criteria to identify such indolent PCa, there is documented evidence that cancer volume, stage, and grade can predict its progression (Albertson, 2010; Klotz, 2012). There are various monograms and predictive models for identifying indolent PCa. But none of these tools or any biological markers alone can differentiate indolent and aggressive disease with reliability. Thaxton, Loeb, Roehl, Kan, & Catalona (2010) examined treatment outcomes in patients who were potential candidates for active surveillance based on three different eligibility criteria and reported more aggressive disease in significant number of patients. Shapiro & Johnstone (2012) reported higher Gleason scores in repeat biopsy or radical prostatectomy for patients who were classified as D'Amico low-risk prostate cancer group based on initial biopsy. The contemporary Prostate cancer Research International: Active Surveillance (PRIAS) study uses the Epstein criteria to identify insignificant disease (Bangma, Bul, & Roobol, 2012). Current criteria have high risk for misclassification and under grading of PCa (Palisaar et al.,2012; Suradi et al.,2008) El Haji et al. (2012) reported similar findings with PRIAS criteria. Generally adopted criteria for AS include patients with PCa in clinical stages of T1c or T2a, Gleason score â‰¤ 6, and serum PSA â‰¤ 10ng/mL. For patients older than 70, a Gleason score of â‰¤ 7 and serum PSA â‰¤ 15ng/mL is acceptable (Filella, Alcover, & Molina, 2011; NIH, 2011; Klotz, 2012). National Comprehensive Cancer Network (NCCN) adds PSA density <0.15 and â‰¤3 positive cores with â‰¤50% in either core to this criteria to safely identify the appropriate candidates (Shapiro & Johnstone, 2012)
Protocol for Disease Monitoring
There is no uniformity in the follow up schedule in various studies which examine the outcome of active surveillance. PRIAS study measures PSA every three months for the first two years along with half yearly digital rectal examination (DRE) followed by half-yearly PSA measurements and annual DRE thereafter. Repeat biopsy is at one year and then every three years except when PSA doubling time (PSADT) is between three and ten years where it is annual (Bangma, Bul, & Roobol, 2012). Another ongoing study, Canary Prostate Active Surveillance Study (PASS), follows up the participants with evaluation of serum PSA every three months, half yearly DRE, and repeat biopsy at the entry level depending on the time of previous biopsy and then biennial repeat biopsies (Newcomb et al., 2010). Monitoring of PSA every three months to calculate PSADT is a well-accepted strategy and PSADT of â‰¤ 3 years indicates a clinically significant disease (Klotz, 2012). Prostate biopsy after one year of initial biopsy is another strategy to identify any high risk disease. After the one year follow up, repeat biopsy every 3-4 years may be required (Klotz, 2012). But NCCN recommends annual biopsies for appropriate monitoring of disease progression (Hilton, Blaschko, Whitson, Cowan, &Carroll, 2012).
Indicators for Curative Treatment.
Always on Time
Marked to Standard
There are no uniform indicators for initiating curative treatment such as surgery or radiation therapy. Various studies supported the use of PSA kinetics such as PSADT, PSA density, and PSA velocity to evaluate the progression of disease and to initiate active treatment (Eggener, 2009). Canary PASS contemplates presence of any one or more of the indicators such as increase in Gleason score, PSADT <3 years and clinical progression evidenced by increased tumor size identified in DRE or any evidence of local or regional metastasis as triggers for aggressive treatment ( Newcomb et al., 2010). PRIAS study considers PSADT of â‰¤ 3 years, Gleason score â‰¥ 6, clinical stage exceeding T2 or >2 positive biopsy cores as indication for initiating treatment (Bangma, Bul, & Roobol, 2012). Ali et al., (2007) proposed PSADT of < 4 years as an indicator for initiating treatment. Optimum indication for treatment is the disease progression evidenced by Gleason score â‰¥7, or extensive disease evidenced by biopsy. PSADT <3 three years indicates the need for biopsy to evaluate the disease progression (Dall'Era, & Carroll, 2009; NIH, 2011).
Outcomes of Active Surveillance
Outcome of any active surveillance program depends highly on patient's age, general health status and comorbidities, inclusion criteria, frequency and extend of monitoring, and indications for initiating intervention. There are side effects for both aggressive therapy and active surveillance. Besides the 0.5% risk of 30- day mortality, sexual dysfunction and urinary incontinence associated with radical prostatectomy and bowel, bladder and sexual dysfunction associated with radiation therapy are the main complications of aggressive management. Side effects of AS are mainly infection associated with prostate biopsy, pain and anxiety about the outcome. Various outcomes of AS are discussed below.
Migration to Active Management
With proper identification of patients for active surveillance and appropriate follow up to identify the progression of disease and timely intervention, there is no significant difference in mortality among patients who undergo aggressive treatment or AS (Klotz, 2007). Eggener et al. (2009) reported that with a median 29 month follow up, patients on AS had a low risk for systemic progression of the disease. Soloway, et al. (2008) reported that 85% of the patients remained in AS at five years. Generally, during the course of AS, a quarter of the patients receive active treatment with in 2 to 3 years. By five years, half of the population might receive the aggressive treatment due to various factors (NIH, 2011).
Twenty two percent of the initial cohort from PRIAS study which started enrolling patients in 2006 has already initiated aggressive treatment (Bangma, Bul, & Roobol, 2012). It is important to examine the outcome of active treatment after the initial period of active surveillance. Majority of the PRIAS cohort transitioned to active treatment based on study protocol and opted radical prostatectomy had localized disease with favorable Gleason grading (Bul et al., 2012). From the National Prostate Cancer Register of Sweden Follow-Up Study, Holmstrom et al. (2012) also reported the absence of any significant difference in pathology or cancer specific mortality in patients who opted to radical prostatectomy initially or after AS. Dall'Era et al. (2011) also supported that prostatectomy after active surveillance does not add any risk for cancer related mortality as majority of the tumors continue to be localized.
One of the reasons for pursuing active surveillance is to avoid complications of treatment such as urinary incontinence and erectile dysfunction. Radomski, Gani, Trottier, & Finelli (2012) examined whether rate of urinary incontinence is higher among patients who pursue active treatment after a period of AS. They reported similar rates of urinary incontinence in these patients which suggests that active surveillance in the initial stages of PCa does not increase the risk of urinary incontinence in the future after the active treatment. Hilton, Blaschko, Whitson, Cowan, & Carroll, (2012) reported that serial prostate biopsies had no effect on erectile function. Thong, Mols, Kil, Korfage, & van de Poll-Franse (2010) reported a comparable health- related quality of life and a lower symptom burden for patients on AS than those who underwent radiation treatment. In a hypothetical cohort of 65 year old men, Hayes et al. (2010) reported a greater Quality-adjusted life expectancy for patients with low risk prostate cancer who opted for AS than those who pursued active treatment. Vasarainen, Lokman, Ruutu, Taari, & Rannikko (2012) examined the quality of life among patients on active surveillance at initial period and at one year and reported better quality of life for the cohort as compared to general population of the same age. Additionally, at one year of active surveillance, none of the patients opted for aggressive management secondary to anxiety. Even though, there is evidence of better quality of life among patients on active surveillance, it is necessary to look at the psychological impact of AS on patients and their significant others.
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The thought of living with cancer without pursuing treatment especially when there is available treatment options can have serious psychological implications in patients and their significant others. The concern and uncertainty about the disease progression and outcome may lead to anxiety, depression and other psychological problems. Burnet, Parker, Dearnaley, Brewin, & Watson (2007) explored the prevalence of anxiety and depression among patients on active surveillance and compared with that of patients receiving aggressive treatment. They reported that the duration of diagnosis was predictive of psychological distress where as being on AS was not associated with high psychological distress in terms of anxiety and depression (Burnet et al., 2007). Couper et al. (2009) compared the psychological wellbeing of patients undergoing various treatment options such as prostatectomy, hormone therapy and other early treatment options including radiation for localized prostate cancer. In the initial period, compared to the AS group, active treatment groups had low health related quality of life ( HRQL) in terms of greater work dysfunction worse social and emotional role functioning and vitality. Reassessment after 12 months showed no significant difference between AS group and patients who opted for prostatectomy or other treatments including radiation whereas patients in the hormone therapy group reported poor HRQL (Couper et al., 2009). Van den Bergh et al. (2010) reported similar anxiety levels in patients who are opting for AS at the initial period and after nine months of surveillance. Seiler et al. (2012) examined the psychological wellbeing and anxiety levels of men who are on active surveillance and their spouses. They had high levels of psychological wellbeing and low levels of anxiety. Interestingly, the spouses had statistically significant higher anxiety and lower psychological wellbeing than men (Seiler et al., 2012). However, there may be significant levels of uncertainty among men who are on AS. Thoughts about the possibility of failure to recognize the progression, metastasis, missing the opportunity for cure, and dying from cancer adds to the uncertainty (Oliffe, Davison, Pickles, & Mróz, 2009).
Economic impact of active surveillance is also promising. Keegan, Dall'Era, Durbin-Johnson, & Evans (2012) reported substantial cost savings for active surveillance after five and ten years of follow up. Annual biopsy increases the cost of AS and reduces the cost savings in the long run. Manoharan (2010) explored the reimbursement for urologists for AS and upfront prostatectomy and revealed that it is equivalent after 3to 4 years of surveillance.
Factors Influencing the Decision for Active Surveillance
Active surveillance has many potential benefits and it is an appropriate management strategy for men with indolent prostate cancer. But only 10% of actual candidates pursue active surveillance (NIH, 2011).There are various factors which influence patients' enrollment in this management strategy. For majority of the patients it is a collective decision between them, family and the provider.
Patients' values and life expectations affect their decision to pursue AS. Uncertainty about the outcome of cancer and the possible risk of disease progression may affect patients' decision making. Some patients and family members may perceive this strategy as 'doing nothing' for the cancer. Concern over multiple biopsies and the possibility of missing the disease progression may also hinder the decision making ((Sandhu & Andriole, 2012). Family support, patient education and physician bias are certain other factors which influence their decision (Gorin, C.T.Soloway, Eldefrawy, & Soloway, 2011). Being married or being in a relationship did not affect the decision to pursue AS or aggressive treatment (Davison & Breckon, 2012). Patients' decision to accept AS depends on their perception of the low risk of their cancer and concern about the common side effects of aggressive treatment and its effect on their quality of life (Dahabreh, 2012; Gorin et al., 2011). Assurance of the availability of treatment options when they need them is another factor which motivates them to consider active surveillance. Age has an impact on their decision making. Davison & Breckon (2012) reported that patients below 60 took an active role in decision making where as those who are above 70 relied on their providers for decision making. There is documented evidence that patients' decision making is highly influenced by the treating specialist (Davison, Oliffe, Pickles, Mroz, 2009; Gorin et al., 2011).
Gorin et al. (2011) reported that only a small proportion of eligible patients received information on AS from their urologists. Though current guidelines from the American urological Association and NCCN recommends active surveillance for low risk prostate cancer, factors such as lack of clear criteria for eligibility, and absence of consistent follow up schedule or clear indicators for intervention make the urologists hesitant to advocate for AS. Gorin et al., (2012) examined the acceptance, knowledge and practice related to AS among urologists. Though there were no problems with knowledge or acceptance of AS, there were concerns about the risk for under grading of cancer, frequency of follow up and biopsy, and missing the opportunities for cure. Aizer et al. (2012) reported higher rate of adoption of AS when patients were receiving multidisciplinary care.
Implications for Practice
Patients with indolent PCa are candidates for AS. Certain strategies can improve patients' acceptance of this management option and providers' willingness and confidence to recommend this option. Evidence based guidelines for selection,monitoring and intervention can ensure favorable outcomes in patients on AS. So generation of evidence on appropriate enrolment criteria for AS, monitoring schedule and indicators for aggressive treatment is a priority in prostate cancer research.
Patient and Family Education
Kazer, Bailey, Colberg, Kelly, & Carroll (2011) identified the lack of information on the disease among patients on AS. The term cancer itself may be a concern for patients and families. Elevated PSA identifies PCa at a very early stage. Assessment of patient's anxiety is essential for the success of any management option. Effective communication and patient education on treatment options and reassurance about the low risk of indolent cancers can relieve the concern of cancer diagnosis and prepare them for active surveillance. Watchful waiting and active surveillance are two different observation strategies. But these terms are used interchangeably. Patients need to know that these are two different strategies and AS is the option where the cancer progression is routinely monitored to evaluate the need for treatment. This will alleviate their concern of 'not doing anything' for their cancer. Patient and family involvement in decision making will provide them a sense of control and responsibility. Involvement in support groups is another beneficial activity to alleviate anxiety. Psychological support and reassurance of partners is an important aspect of surveillance care.
Patients and families value their provider's involvement in decision making on their management. There is supportive evidence on physician influence in patient's decision to choose AS. There is evidence supportive of physician's attitude and bias which can also influence patient's management choices (Pickles et al., 2007). Provider education on outcomes of AS based on contemporary trials can generate provider support. Additionally, an evidence based criteria for eligibility and monitoring will alleviate provider concerns.
Though it is necessary to have individualized criteria for deciding the eligibility for AS, accurate grading of the disease is vital to the patient outcome. Progression of PCa is found to be higher in the first one or two years of AS which supports the possible under grading of the disease rather than disease progression (Duffield, Lee, Miyamoto, Carter, & Epstein, 2009). This emphasizes the need for repeat biopsy with adequate sampling for deciding the eligibility. Reassignment of Gleason score and standardization of PSA using WHO standards can improve the reliability of selection criteria. Diagnostic tests such as MRI also may prove helpful in accurate identification of candidates.
Evidence based consensus on ideal regimen for monitoring and frequency for biopsy may improve provider confidence and patient adherence to AS. It may be beneficial to initiate some adjunctive therapies such as dutasteride or local ablation which will slow down the progression and provide psychological reassurance to the patients (Flesher et al., 2012; Sandhu, & Andriole, 2012). Integration of new biomarkers to detect the progress of disease may be a future strategy (Bastian et al., 2009).
Multidisciplinary approach is the ideal way to continue the surveillance and to improve their self-management and self-efficacy. It is unrealistic to expect the urologist as a sole provider to meet patient needs such as wellness needs, lifestyle and behavioral modification, management of comorbidities, psychological needs, and patient and family education needs. Patients and families need to perceive a continuum of care in their journey with prostate cancer.
Active surveillance is an ideal management strategy for indolent prostate cancer. Evidence based guidelines for the eligibility and continued monitoring will improve providers' attitude towards AS. Communication, psychological reassurance, and patient education will help alleviate uncertainty and improve patient enrolment in AS. Thus AS can prove as a management option to decrease symptom burden and economic impact related to active treatment.
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