Medium-term Outcomes of Active Surveillance for Localised Prostate Cancer
TL;DR: This study demonstrates satisfactory medium-term outcomes for AS in selected men with localised prostate cancer, using Kaplan-Meier methods.
About: This article is published in European Urology.The article was published on 2013-12-01. It has received 216 citations till now. The article focuses on the topics: Prostate biopsy & PSA Velocity.
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TL;DR: Among men undergoing biopsy for suspected prostate cancer, targeted MR/ultrasound fusionBiopsy, compared with standard extended-sextant ultrasound-guided biopsy, was associated with increased detection of high-risk prostate cancer and decreased detection of low- risk prostate cancer.
Abstract: Importance Targeted magnetic resonance (MR)/ultrasound fusion prostate biopsy has been shown to detect prostate cancer. The implications of targeted biopsy alone vs standard extended-sextant biopsy or the 2 modalities combined are not well understood. Objective To assess targeted vs standard biopsy and the 2 approaches combined for the diagnosis of intermediate- to high-risk prostate cancer. Design, setting, and participants Prospective cohort study of 1003 men undergoing both targeted and standard biopsy concurrently from 2007 through 2014 at the National Cancer Institute in the United States. Patients were referred for elevated level of prostate-specific antigen (PSA) or abnormal digital rectal examination results, often with prior negative biopsy results. Risk categorization was compared among targeted and standard biopsy and, when available, whole-gland pathology after prostatectomy as the "gold standard." Interventions Patients underwent multiparametric prostate magnetic resonance imaging to identify regions of prostate cancer suspicion followed by targeted MR/ultrasound fusion biopsy and concurrent standard biopsy. Main outcomes and measures The primary objective was to compare targeted and standard biopsy approaches for detection of high-risk prostate cancer (Gleason score ≥ 4 + 3); secondary end points focused on detection of low-risk prostate cancer (Gleason score 3 + 3 or low-volume 3 + 4) and the biopsy ability to predict whole-gland pathology at prostatectomy. Results Targeted MR/ultrasound fusion biopsy diagnosed 461 prostate cancer cases, and standard biopsy diagnosed 469 cases. There was exact agreement between targeted and standard biopsy in 690 men (69%) undergoing biopsy. Targeted biopsy diagnosed 30% more high-risk cancers vs standard biopsy (173 vs 122 cases, P Conclusions and relevance Among men undergoing biopsy for suspected prostate cancer, targeted MR/ultrasound fusion biopsy, compared with standard extended-sextant ultrasound-guided biopsy, was associated with increased detection of high-risk prostate cancer and decreased detection of low-risk prostate cancer. Future studies will be needed to assess the ultimate clinical implications of targeted biopsy. Trial registration clinicaltrials.gov Identifier: NCT00102544.
1,291 citations
TL;DR: This guideline attempts to improve a clinician’s ability to treat patients diagnosed with localized prostate cancer, but higher quality evidence in future trials will be essential to improve the level of care for these patients.
662 citations
TL;DR: This guideline attempts to improve a clinician's ability to treat patients diagnosed with localized prostate cancer, but higher quality evidence in future trials will be essential to improve the level of care for these patients.
283 citations
TL;DR: Outcomes of active surveillance seem to be closely associated with programme-specific criteria for selection, monitoring, and intervention, suggesting that AS — like other management strategies — could be individualized based on the level of risk acceptable to patients in light of their personal preferences.
Abstract: Prostate cancer remains one of the most commonly diagnosed malignancies worldwide. Early diagnosis and curative treatment seem to improve survival in men with unfavourable-risk cancers, but significant concerns exist regarding the overdiagnosis and overtreatment of men with lower-risk cancers. To this end, active surveillance (AS) has emerged as a primary management strategy in men with favourable-risk disease, and contemporary data suggest that use of AS has increased worldwide. Although published surveillance cohorts differ by protocol, reported rates of metastatic disease and prostate-cancer-specific mortality are exceedingly low in the intermediate term (5-10 years). Such outcomes seem to be closely associated with programme-specific criteria for selection, monitoring, and intervention, suggesting that AS--like other management strategies--could be individualized based on the level of risk acceptable to patients in light of their personal preferences. Additional data are needed to better establish the risks associated with AS and to identify patient-specific characteristics that could modify prognosis.
182 citations
Additional excerpts
...Royal Marsden ≤T2 ≤6 ≤50% N/A N/A N/A Age 50–80 years Selvadurai et al.(24)...
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TL;DR: Significant prostate cancer related morbidity and mortality remained rare at intermediate followup and prostate specific antigen density was independently associated with biopsy reclassification and treatment while on active surveillance.
144 citations
References
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TL;DR: Low-risk patients had estimates of 5-year PSA outcome after treatment with RP, RT, or implant with or without neoadjuvant androgen deprivation that were not statistically different, whereas intermediate- and high- risk patients treated with RP or RT did better then those treated by implant.
Abstract: Context.—Interstitial radiation (implant) therapy is used to treat clinically
localized adenocarcinoma of the prostate, but how it compares with other treatments
is not known.Objective.—To estimate control of prostate-specific antigen (PSA) after radical
prostatectomy (RP), external beam radiation (RT), or implant with or without
neoadjuvant androgen deprivation therapy in patients with clinically localized
prostate cancer.Design.—Retrospective cohort study of outcome data compared using Cox regression
multivariable analyses.Setting and Patients.—A total of 1872 men treated between January 1989 and October 1997 with
an RP (n=888) or implant with or without neoadjuvant androgen deprivation
therapy (n=218) at the Hospital of the University of Pennsylvania, Philadelphia,
or RT (n=766) at the Joint Center for Radiation Therapy, Boston, Mass, were
enrolled.Main Outcome Measure.—Actuarial freedom from PSA failure (defined as PSA outcome).Results.—The relative risk (RR) of PSA failure in low-risk patients (stage T1c,
T2a and PSA level ≤10 ng/mL and Gleason score ≤6) treated using RT,
implant plus androgen deprivation therapy, or implant therapy was 1.1 (95%
confidence interval [CI], 0.5-2.7), 0.5 (95% CI, 0.1-1.9), and 1.1 (95% CI,
0.3-3.6), respectively, compared with those patients treated with RP. The
RRs of PSA failure in the intermediate-risk patients (stage T2b or Gleason
score of 7 or PSA level >10 and ≤20 ng/mL) and high-risk patients (stage
T2c or PSA level >20 ng/mL or Gleason score ≥8) treated with implant compared
with RP were 3.1 (95% CI, 1.5-6.1) and 3.0 (95% CI, 1.8-5.0), respectively.
The addition of androgen deprivation to implant therapy did not improve PSA
outcome in high-risk patients but resulted in a PSA outcome that was not statistically
different compared with the results obtained using RP or RT in intermediate-risk
patients. These results were unchanged when patients were stratified using
the traditional rankings of biopsy Gleason scores of 2 through 4 vs 5 through
6 vs 7 vs 8 through 10.Conclusions.—Low-risk patients had estimates of 5-year PSA outcome after treatment
with RP, RT, or implant with or without neoadjuvant androgen deprivation that
were not statistically different, whereas intermediate- and high-risk patients
treated with RP or RT did better then those treated by implant. Prospective
randomized trials are needed to verify these findings.
3,408 citations
TL;DR: The panel recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (no hormonal therapy) with strict adherence to guidelines as to "adequate follow-up."
Abstract: In 1996 the American Society for Therapeutic Radiology and Oncology (ASTRO) sponsored a Consensus Conference to establish a definition of biochemical failure after external beam radiotherapy (EBRT). The ASTRO definition defined prostate specific antigen (PSA) failure as occurring after three consecutive PSA rises after a nadir with the date of failure as the point halfway between the nadir date and the first rise or any rise great enough to provoke initiation of therapy. This definition was not linked to clinical progression or survival; it performed poorly in patients undergoing hormonal therapy (HT), and backdating biased the Kaplan-Meier estimates of event-free survival. A second Consensus Conference was sponsored by ASTRO and the Radiation Therapy Oncology Group in Phoenix, Arizona, on January 21, 2005, to revise the ASTRO definition. The panel recommended: (1) a rise by 2 ng/mL or more above the nadir PSA be considered the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure be determined "at call" (not backdated). They recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (no hormonal therapy) with strict adherence to guidelines as to "adequate follow-up." To avoid the artifacts resulting from short follow-up, the reported date of control should be listed as 2 years short of the median follow-up. For example, if the median follow-up is 5 years, control rates at 3 years should be cited. Retaining a strict version of the ASTRO definition would allow comparisons with a large existing body of literature.
2,331 citations
Additional excerpts
...2 ng/ml after RP, or by the Phoenix criteria (nadir +2 ng/ml) after EBRT [12]....
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...The treated population included all patients who consented to the study, fulfilled the eligibility criteria, and had since started EBRT or had undergone brachytherapy or RP. PSAV was calculated using linear regression based on a minimum of four values and observed over a minimum of 6 mo. Kaplan-Meier methods were used to describe clinical outcomes....
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...He underwent treatment with ADT and EBRT but relapsed within 2 yr with bone metastases and subsequently died 8 yr after initial diagnosis....
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...Biochemical failure after deferred radical treatment was defined as a PSA level >0.2 ng/ml after RP, or by the Phoenix criteria (nadir +2 ng/ml) after EBRT [12]....
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...Time to biochemical failure was assessed in the radically treated population only and was measured from the start date of treatment, which was taken to be the first day of EBRT or date of RP. Patients with no recorded PSA value after treatment were censored at the start of treatment....
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University of Minnesota1, Harvard University2, Veterans Health Administration3, Agency for Healthcare Research and Quality4, University of Pittsburgh5, University of Michigan6, United States Department of Veterans Affairs7, University of Texas at Dallas8, Washington University in St. Louis9, University of Oklahoma10, Baylor College of Medicine11
TL;DR: Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up.
Abstract: During the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radi cal prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P = 0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P = 0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P = 0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P = 0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death. CONCLUSIONS Among men with localized prostate cancer detected during the early era of PSA test ing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials .gov number, NCT00007644.)
1,590 citations
TL;DR: A low rate of prostate cancer mortality was observed among the patients who were reclassified as higher risk and who were treated, PSA failure was relatively common and other-cause mortality accounted for almost all of the deaths.
Abstract: Purpose We assessed the outcome of a watchful-waiting protocol with selective delayed intervention by using clinical prostate-specific antigen (PSA), or histologic progression as treatment indications for clinically localized prostate cancer. Patients and Methods This was a prospective, single-arm, cohort study. Patients were managed with an initial expectant approach. Definitive intervention was offered to those patients with a PSA doubling time of less than 3 years, Gleason score progression (to 4 + 3 or greater), or unequivocal clinical progression. Survival analysis and Cox proportional hazard model were applied to the data. Results A total of 450 patients have been observed with active surveillance. Median follow-up was 6.8 years (range, 1 to 13 years). Overall survival was 78.6%. The 10-year prostate cancer actuarial survival was 97.2%. Overall, 30% of patients have been reclassified as higher risk and have been offered definitive therapy. Of 117 patients treated radically, the PSA failure rate was ...
1,064 citations
"Medium-term Outcomes of Active Surv..." refers background in this paper
...It is one of only three reported, prospective, AS cohorts Table 6 – Prospective active surveillance studies Study n Median follow-up, yr Freedom from treatment Biochemical control after deferred treatment Prostate cancer mortality, % Mortality from other causes UCSF [5,23,24] 321 3.6 67% at 5 yr 1 recurrence at 3 yr 0 0 University of Toronto [2,25] 450 6.8 70% at 5 yr 5-yr recurrence-free survival: 47% 3 at 10 yr 10-yr OS: 68% Multicentre PRIAS [6,7] 2494 1.6 77% at 2 yr No data 0 4-yr OS: 87% University of Miami [4] 230 2.6 85.7% at 5 yr No recurrences 0 No data Johns Hopkins [3,26] 769 2.7 59% at 5 yr 90.6% recurrence free at 2 yr 0 1.8% of cohort Royal Marsden (current study) 471 5.7 70% at 5 yr 85% PSA-failure free at 5 yr 2% at 8 yr 9% at 8 yr UCSF = University of California San Francisco; OS = overall survival; PRIAS = Prostate Cancer Research International: Active Surveillance; PSA = prostate-specific antigen. worldwide with a similar study population size and duration of follow-up....
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...6 67% at 5 yr 1 recurrence at 3 yr 0 0 University of Toronto [2,25] 450 6....
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Journal Article•
891 citations
"Medium-term Outcomes of Active Surv..." refers background in this paper
...The outcome of deferred treatment appears comparable to that of immediate treatment [13,14] and the risk for death from PCa within the time frame of the study is very low....
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