The Role of Active Surveillance in the Management of Men ...



Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational management strategies

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ active |Definition of progression |

|Enrollment year | | |therapy | |

|Baylor College of |Prostate cancer diagnosed by needle biopsy|Pathological features of the biopsy results, clinical stage |Definitive treatment when objective |A point system for evaluating |

|Medicine and MSKCC, |or transurethral resection and Gleason sum|and/or PSA influenced the decision to proceed with the |progression or patients’ requests. |progression, including Gleason|

|US106 |7 or less. All patients were eligible for |deferred therapy protocol. |Definitive treatment included RP and |score increase, PSA velocity, |

|[15017211] |definitive therapy in the form of RP or |Prospectively designed protocol of deferred therapy: office |RT. |DRE/TRUS, and biopsy specimen.|

| |RT. |evaluations every 3 mo first yr and every 6 mo thereafter. | | |

|1984-2001 |No patient had significant comorbidities. |It included digital DRE and PSA. Repeat TRUS guided sextant | | |

| |The decision for deferred therapy was made|biopsy was recommended at 6 mo or if the patient showed | | |

| |by the patient and treating physician |DRE/TRUS or PSA abnormalities consistent with disease | | |

| |together based on the likely presence of |progression. PSA velocity was calculated from 3 separate | | |

| |small volume cancer. |recorded values in a 12-mo period. | | |

|BCCA, Canada157 |Patients who were placed onto a watchful |No fixed follow-up schedule; patients generally were seen |NR |Clinical progression: an |

|[9445192] |waiting program. Patient who had received |every 3-6 mo as needed. | |increase in palpable disease |

| |treatment (either hormones or PT) prior to|PSA at diagnosis and all subsequent followup PSA were | |or T classification. |

|NR |the referral were excluded. |recorded. | |Biochemical progression: PSA |

| | | | |DT calculated by 2 methods. |

|Cleveland clinic, US119 |Low-risk features by D’Amico criteria; a |PSA every 6-12 mo, surveillance biopsy was usually performed|Intervention was recommended to |NR |

|[21256549] |repeat (confirmation) prostate biopsy of |every 2 yr or sooner. |patients considering multiple | |

| |≥10 cores; favorable clinical and | |parameters (PSA and PSA kinetics, | |

|2004-2009 |pathologic features at the diagnostic and | |changes in DRE, quantity of cancer in | |

| |repeat biopsy; absence of primary or | |biopsy specimens, and biopsy Gleason | |

| |secondary Gleason scores 4 or 5. | |score) | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|Dana-Farber Cancer |Clinically localized disease (T1c-T2c), |PSA and DRE every 6 mo, and 20-core biopsy every 12 to 18 mo |Patients with progression were offered|Progression criteria: 1) 3 or |

|Institute, US117 |Gleason score 6 or less with no pattern 4,|Protocol with cure intent. |surgery or radiotherapy. |more positive cores, 2) |

|[21167525] |40%. |

| |treat was made by the |and PSA tests.150 |treatment (5 for subjective symptoms; |Metastatic progression: new |

| |urologist in discussion | |1 for objective progression only). The|bone lesion. |

| |with the patient and his| |authors also reported that PSA | |

| |family, with respect to | |progression may serve as a trigger | |

| |patient age, general | |point to treatment.150 | |

| |health, clinical stage | | | |

| |and patient preference. | | | |

| |All patients had | | | |

| |estimated survival >1 | | | |

| |yr. | | | |

| |Men on AS who were | | | |

| |detected within the | | | |

| |screening | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

| |program of the ERSPC. | | | |

| |All men retrospectively | | | |

| |met the following | | | |

| |criteria: clinical stage| | | |

| |T1c or T2, PSA ≤15 | | | |

| |ng/mL, and Gleason score| | | |

| |10 yr, and were defined|and every 1 to 3 yr after starting AS. | | |

|1991-2007 |as age ≤75 yr, clinical | | | |

| |stage T1-T2a, PSA ≤10 | | | |

| |ng/mL, ≤3 positive cores| | | |

| |at diagnostic biopsy, | | | |

| |Gleason score ≤6, no | | | |

| |active treatment for a | | | |

| |minimum of 6 mo after | | | |

| |the second biopsy. | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|Freeman hospital, UK141 |Patients without |Disease progression was monitored by history, physical exam, TRUS for T staging|No treatment until symptomatic |NR |

|[3191340] |symptoms after initial |and prostate volume since 1983, serum acid and alkaline phosphatase and |progression. | |

| |outflow tract surgery or|6-monthly isotope bone scans. | | |

|1978-1985 |biopsy. | | | |

|Hospitals in Manchester,|“Localized” (bone |Patients were followed-up at 6-month intervals. All patients underwent |Hormonal manipulation was demanded by |Bone scan for metastases; PSA |

|UK148 |scan-negative) prostate |“multiple bone scans” (all negative), and hormonal manipulation was demanded by|the protocol when the PSA rose to 50 |levels. |

|[11711356] |cancer patients treated |the protocol when the PSA rose to 50 ng/mL. DRE not always performed in patient|ng/mL. | |

| |by watchful-waiting. All|with long-standing, stable PSA values. | | |

|NR |patients had PSA level 2 |biopsy249 |

| |biopsy: Gleason ≤6; no | |cores cancer positive; or single core | |

|1994-2008 |Gleason pattern ≥4; ≤2 | |>50% cancer. | |

| |cores cancer positive; | |Patient request or encouraged to seek | |

| |≤50% cancer in any | |curative treatment if perineural | |

| |single core (also | |invasion on biopsy.137 | |

| |included some men who | |PSA kinetics not used as a trigger for| |

| |did not meet these | |intervention. | |

| |criteria due to personal| | | |

| |preference or | | | |

| |comorbidity) | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|Kagawa Medical Univ., |Japanese patients with |PSA doubling time based on 1st PSA >1 mo after biopsy. ≥3 values at intervals |NR |NR |

|Japan153 |nonpalpable prostate |≥1 mo apart for >6 mo. Exponential slope fitted by regression. | | |

|[10765093] |cancer, detected by | | | |

| |elevated PSA. Diagnosed | | | |

|1990-1998 |histopathologically by | | | |

| |TRUS-guided six sextant | | | |

| |biopsy: (1) Gleason | | | |

| |score ≤6; (2) 1-2 | | | |

| |positive cores per 6 | | | |

| |sextant cores; and (3) | | | |

| |≤50% involvement of any | | | |

| |positive core | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|Kagawa Medical Univ., |50-80 yr, initial PSA |PSA every 2 mo for 6 mo, every 3 mo thereafter. |PSADT ≤2 yr after 6 mo (based on all |NR |

|Japan118 |≤20 ng/mL, 1-2 positive |Re-biopsy at 1 yr (no data beyond 1 yr) |PSA or most recent 1 yr) | |

|[18272471] |cores per 6-12 | |Re-biopsy did not fit initial | |

| |systematic biopsy cores,| |pathology criteria | |

|2002-2003 |Gleason score ≤6, ≤50% | | | |

| |cancer involvement in | | | |

| |any core. Excluded if | | | |

| |comorbidities: past | | | |

| |stroke, unstable angina,| | | |

| |DM uncontrollable with | | | |

| |insulin, severe HTN, MI | | | |

| |w/in 6 mo. | | | |

|Kansas City VA, US158 |Low-risk prostate cancer|PSA every 3 mo and a repeat TRUS guided prostate biopsy at 1 yr. All biopsies |NR |NR |

|[21172105]] |patients: stage T2 or |were performed using a standard 12-core biopsy scheme, however, an increased | | |

| |less, Gleason ≤6, PSA |number of biopsies were taken for larger glands. | | |

|2004-2009 |50% cancer in at least |

| |parameters” (“clinically| |based on the suggestion of disease |1 core, or Gleason pattern of |

| |localized caner”26) or | |progression because of a rising PSA |4 |

| |patients who decline | |level or clinical progression on DRE |Development of metastatic |

| |definitive treatment. | |or repeated sextant biopsy.26 |disease.26 |

| |The reasons for AS | | | |

| |included patient choice,| | | |

| |limited life expectancy | | | |

| |because of advanced age | | | |

| |or poor medical | | | |

| |condition, and presumed | | | |

| |insignificant prostate | | | |

| |cancer. | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|Memorial Sloan-Kettering|Low-risk prostate cancer|Semiannually with DRE, free and total PSA measurements, and a review of general|Treatment was recommended when the |NR |

|Cancer Center, US115 |patients who were |health and urinary symptoms. Biopsy was routinely recommended within 12 to 18 |patient no longer met study | |

|[21167529] |eligible for AS; PSA 50% cancer | | | |

| |involvement and | | | |

| |confirmatory biopsy to | | | |

| |reassess eligibility | | | |

| |before starting AS | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|Northern Stockholm, |Patients with clinically|Followup was performed every 3 to 6 mo for the first 2 yr and every 6 to 12 |Treatment was offered to the patients |Clinical progression: positive|

|Sweden140 |localized prostate |months thereafter with DRE and PAP. Re-biopsies were done every year during the|if clinical progression with symptoms |bone scan or plain x-ray for |

|[17467883] |cancer, diagnosed by |first 4 yr, and a bone scan was repeated every 12 to 18 mo. |occurred. |the diagnosis of skeletal |

| |biopsies and cytological| | |metastases. |

|1978-1982 |assessment, initially | | | |

| |managed with WW. | | | |

| |Patients with palpable | | | |

| |tumors (71% T1-2 and 29%| | | |

| |with T3) were included | | | |

| |in a prospective | | | |

| |surveillance protocol | | | |

| |with close follow-up. | | | |

| |Bone scan and PAP were | | | |

| |normal in all patients. | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|Orebro Medical Center, |Patients were given no |Every 6 to 12 mo, patients were followed with clinical exam, lab tests |Patients were treated hormonally if |NR |

|Sweden139 |initial treatment if the|including PAP and bone scans. |disease progressed for they had | |

|[7933233] |tumor was localized to |PSA was only performed during the last few yr. |symptoms of progression. | |

| |the prostate gland | | | |

|1977-1984 |without penetration of | | | |

| |the capsule on DRE | | | |

| |(stages T0 to T2) and | | | |

| |there was no evidence of| | | |

| |distant metastases. | | | |

| |However, several | | | |

| |restrictions were | | | |

| |applied to those with a | | | |

| |palpable tumor (stages | | | |

| |T1 to T2). | | | |

| |From March 1978 to Feb. | | | |

| |1979, patients >75 yr | | | |

| |were not given any | | | |

| |initial treatment | | | |

| |(deferred treatment). | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|PASS, US121 |Clinical stage T1-2, |PSA every three mo; DER every 6 mo |Active treatment will be offered to a |PSA DT < 3 year, any increase |

|[19758683] |NX/0, MX/0, no previous |Rebiopsy at the baseline visit if a biopsy with >10 cores is not available, at |participant who showed disease |in Gleason grade, and clinical|

| |treatment for prostate |6-12 mo from the baseline visit, at 2 years, then every 2 years. |progression, but the participant may |progression |

|2008 - ongoing |cancer (including | |opt to remain on AS. If this occurs, a| |

| |hormone therapy), ECOG | |new PSA/stage/grade status will be | |

| |performance status 0 or | |assigned and further progression | |

| |1, elected AS as | |events will be determined using the | |

| |preferred management | |new baseline criteria. | |

| |plan, If diagnosis ≤1 | | | |

| |year of entry, at leat 1| | | |

| |biopsy with ≥10 cores, | | | |

| |if diagnosis >1 year | | | |

| |before entry, minimum of| | | |

| |2 biopsies, 1 ≤2 years | | | |

| |before entry, no other | | | |

| |malignancies except skin| | | |

| |cancer or superficial | | | |

| |bladder cancer | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|PIVOT, US 146 |Biopsy proven |Office visit & PSA every 6 mo |Discouraged treatment for asymptomatic|NR |

|[18783735] |T1-T2/Nx/M0 prostate |Bone scan every 5 yr |progression (e.g., per PSA) | |

| |cancer of any | | | |

|1994-2002 |histological grade, | | | |

| |diagnosed within 12 mo, | | | |

| |PSA≤50 ng/mL, ≤75 yr, | | | |

| |bone scan negative for | | | |

| |metastatic disease, | | | |

| |estimated life | | | |

| |expectancy >10 yr, | | | |

| |medically and surgically| | | |

| |fit for RP | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|PRIAS, Netherlands120 |Originating from the |PSA at 3 mo, DRE at 6 mo and standard rebiopsy after 1 yr. |PSA DT 0 to 3 yr, T state >2 or |NR |

|[19817747] |ERSPC.151 | |rebiopsy findings exceed study | |

| |Histologically proven | |inclusion thresholds | |

|2006 – ongoing |adenocarcinoma of the | | | |

| |prostate; fit for | | | |

| |curative treatment; | | | |

| |PSA-level at diagnosis ≤| | | |

| |10 ng/mL; PSA density ≤ | | | |

| |0.2 ng/ml/ml; clinical | | | |

| |stage T1c or T2; | | | |

| |adequate biopsy sampling| | | |

| |according to biopsy | | | |

| |protocol; Gleason score | | | |

| |≤3+3=6; maximal 2 biopsy| | | |

| |cores invaded with | | | |

| |prostate cancer; willing| | | |

| |to attend the follow-up | | | |

| |visits. | | | |

|Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active surveillance/ watchful waiting/other observational |

|management strategies (continued) |

|Center, Country [PMID] |Eligibility criteria |Followup or monitoring protocol |Triggers for intervention/ |Definition of progression |

|Enrollment year | | |active therapy | |

|Princess Margaret |PSA ................
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