Active Surveillance For Prostate Cancer Research Articles

The health-related quality of life in patients with prostate cancer managed with active surveillance using the Expanded Prostate Cancer Index Composite survey: Systematic review and meta-analysis

ABSTRACT Objective To examine the health-related quality of life (HRQoL) of patients with prostate cancer managed with active surveillance (AS) compared with those who receive definitive treatment using the Expanded Prostate Cancer Index Composite (EPIC) Survey. Methods We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and searched PubMed and ScienceDirect for articles published between April 2010 and April 2020. Eligible studies reported original data on the HRQoL of men undergoing AS for prostate cancer, including studies comparing AS to curative methods particularly radical prostatectomy, radiotherapy, and brachytherapy. Results We identified nine eligible articles, all were non-experimental observational studies of which seven were longitudinal and two were cross-sectional studies. The EPIC questionnaire was the main instrument used in all studies to assess the HRQoL. AS was noted to show the highest calculated mean score among management groups in all comparative studies at study endpoints including cross-sectional studies (95% confidence interval 2.17–5.75, P < 0.001). The maximum score deterioration for patients who were managed with AS in all studies was only 7.5 points (12.2%) after 2 years follow-up. AS had the least mean score decline among all management groups. Patients with a normal testosterone level were found to have high HRQoL scores. The number of prostate biopsies did not correlate with the HRQoL score. Conclusion Patients with prostate cancer managed with AS report less impacts on their HRQoL compared to patients who receive definitive treatments. However, further high-quality research with long-term data are required to help both the patient and the physician in making a well-informed management decision.

Comparison of outcomes of different biopsy schedules among men on active surveillance for prostate cancer: An analysis of the G.A.P.3 global consortium database.

BackgroundThe optimal interval for repeat biopsy during active surveillance (AS) for prostate cancer is yet to be defined. This study examined whether risk of upgrading (to grade group ≥ 2) or risk of converting to treatment varied according to intensity of repeat biopsy using data from the GAP3 consortium's global AS database.Materials and MethodsIntensity of surveillance biopsy schedules was categorized according to centers’ protocols: (a) Prostate Cancer Research International Active Surveillance project (PRIAS) protocols with biopsies at years 1, 4, and 7 (10 centers; 7532 men); (b) biennial biopsies, that is, every other year (8 centers; 4365 men); and (c) annual biopsy schedules (4 centers; 1602 men). Multivariable Cox regression was used to compare outcomes according to biopsy intensity.ResultsOut of the 13,508 eligible participants, 56% were managed according to PRIAS protocols (biopsies at years 1, 4, and 7), 32% via biennial biopsy, and 12% via annual biopsy. After adjusting for baseline characteristics, risk of converting to treatment was greater for those on annual compared with PRIAS biopsy schedules (hazard ratio [HR] = 1.66; 95% confidence interval [CI] = 1.51–1.83; p < 0.001), while risk of upgrading did not differ (HR = 0.96; 95% CI = 0.84–1.10).ConclusionResults suggest more frequent biopsy schedules may deter some men from continuing AS despite no evidence of grade progression.

Outcomes and factors associated with reclassification in a multiethnic cohort enrolled in active surveillance for prostate cancer.

242 Background: Active surveillance (AS) is the standard of care for low-risk prostate cancer (PCa). However, there is limited data exploring factors associated with reclassification among non-Hispanic Black (NHB) and Hispanic men enrolled in AS. In this study, we examined factors associated with reclassification among men enrolled in AS within a multiethnic population. Methods: We identified men enrolled in AS from 2005-2019 at our institution, and collected demographic/clinical data. We then compared characteristics among men who experienced pathologic reclassification while on AS vs men who did not. Reclassification was defined as either type 1 (Grade Group (GG) 1 to GG2) or type 2 (GG1 to ≥GG3). Our AS protocol generally consists of biannual prostate specific antigen (PSA) testing and prostate biopsy every 1-3 years. Prostate MRI is used to guide decisions on selective basis. Logistic regression was used to determine factors associated with reclassification. Results: Among 197 men enrolled into an AS protocol within our institution, 133 (67.5%) did not experience reclassification by the end of follow-up while 64 (32.5%) did (Table). Median follow-up time was 12 months (IQR: 7-20), and 2-year overall reclassification-free rates were 59.3% (95% CI: 59.2-59.4). 2-year deferred treatment rates were 26.4% (95% CI: 26.3-26.5) for radical prostatectomy (RP) and 16.9% (95% CI: 16.8-17.0) for radiation therapy (RT). NHB and Hispanic men composed 87 (44.2%) and 70 (35.5%) of our cohort, respectively. Higher PSA at diagnosis was associated with adverse reclassification (OR=1.02, 95% CI: 1.01-1.05, p=0.002), and there was a trend towards NHB men having higher odds of experiencing reclassification (OR=2.78, 95% CI: 0.85-9.10) although the result was not statistically significant (p=0.09). Conclusions: In a diverse, multiethnic cohort, rates of adverse reclassification on AS were relatively low. The only factor predictive of reclassification while on AS was higher median PSA at diagnosis; however, NHB men did have a trend towards a higher odds of reclassification. Our results suggest that men who are NHB or have higher PSA at diagnosis may benefit from increased surveillance intensity, as they are more likely to experience reclassification while on AS.[Table: see text]

Immunotherapy to prevent progression on active surveillance study (IPASS): A phase II, randomized, double-blind, controlled trial of PROSTVAC in prostate cancer patients who are candidates for active surveillance.

249 Background: Immunotherapy could potentially prevent disease progression for early-stage prostate cancer. In this randomized Phase 2 clinical trial, we evaluated the clinical effects of PROSTVAC, a vaccinia/fowlpox viral vector-based immunotherapy that contains PSA and three T-cell costimulatory molecules, in patients with localized prostate cancer. Methods:154 patients with clinically localized, low- or favorable intermediate-risk prostate cancer active surveillance were randomized (2:1) to receive 7 doses of subcutaneous PROSTVAC or placebo (empty fowlpox vector) over 140 days. Post-intervention prostate biopsy was performed 7-14 days after the last dose. Participants were followed for 6 months post-treatment. The primary outcome was change from baseline to post-vaccination in CD4 and CD8 T cell infiltration in biopsy tumor tissue. Secondary outcomes included changes in prostate biopsy Gleason grade (Grade Group) and serum PSA. Results: There were no differences in CD4 and CD8 densities (count of cells/mm2) in post-treatment biopsy tumor tissue between groups ( p = 0.63 and p = 0.75, respectively). Compared to placebo, patients who received PROSTVAC were less likely to demonstrate upgrading at follow-up biopsy, but this difference did not attain significance (22% vs. 40%, p= 0.08). There was no difference in the change of PSA from baseline to 6 months post-treatment between arms ( p= 0.30). Conclusions: In this first-of-kind trial of immunotherapy for localized prostate cancer, PROSTVAC was well tolerated but did not elicit significant prostate tissue T-cell responses compared to placebo. The favorable post-treatment biopsy grade findings in PROSTVAC patients merit further evaluation and longer-term clinical follow-up. Clinical trial information: NCT02326805.

Contemporary outcomes of a systematic prostate cancer active surveillance program: Results from the Niagara Health System, Ontario, Canada.

241 Background: Surgery and radiotherapy are standard therapies for patients with early-stage prostate cancer (PrCa). However, studies show that patients with low-risk localized PrCa (Gleason 6; Grade Group (GG) 1 and prostate-specific antigen (PSA) &lt;10) could be safely monitored with active surveillance (AS), if intense patient follow up and re-biopsy schedules are utilized. Here, we reviewed clinical outcomes of AS of a program associated with the Niagara Health System (NHS) PrCa diagnostic program, which provides centralized diagnosis, systematic follow up, re-biopsy and multi-disciplinary consultation clinics for all patients in the Niagara region, Ontario, Canada. Methods: After receiving appropriate ethics approval, NHS databases were searched for patients that underwent more than one biopsy of the prostate in the period Jan. 2015 (program inception) to Dec. 2020. Cases were reviewed for clinical stage, biopsy results and treatment record data. Data were then codified for anonymity and analyzed. Criteria for inclusion into the analysis involved, i) a minimum of two PrCa biopsies before treatment and ii) detailed reporting of biopsy and clinical results (number of positive cores, % of core involvement, and PSA). Results: A total of 343 AS patient cases were identified in the initial search. Of those 52 cases did not meet inclusion criteria. The baseline GG score distribution in the 291 cases included in the analysis was, GG0: 27 (cases with negative biopsies but high PSA), GG1: 247 and GG2: 17 (patients refusing treatment). A total of 144 cases (49.5%) progressed at re-biopsy. Rates of progression to higher GG category in the three groups were 100%, has 46.5% and 50%, respectively. The average time to progression was 23.3+15.5 months. The rate of progression to treatment after entering AS was 39.17% (114/291). Average time from first biopsy to treatment was (28.4+14.5 months). Amongst those that received treatment the overall rate of progression to high-intermediate or high-risk PrCa, was 29.8%, with 20.8% of cases (30/144) progressing to GG&gt;3 (Gleason Score 7: 4+3 or higher) and 9.0% (13/144) progressing to PSA &gt; 20. Of the treated patients, 70 (61.4%) patients received radiotherapy, 42 (36.8%) combined radiotherapy and androgen deprivation therapy and (31.3%) underwent radical prostatectomy. Conclusions: This retrospective study provides contemporary real-world systematic AS outcomes from a Canadian program with unique features of systematic urological follow up and centralized diagnosis and multi-disciplinary patient assessment. We observe increased rates of disease progression and need for earlier utilization of treatment compared to those reported by other studies. Further analysis examines factors predicting increased risk for disease progression.

A Randomized Trial of the Effects of Exercise on Anxiety, Fear of Cancer Progression and Quality of Life in Prostate Cancer Patients on Active Surveillance.

We examined the effects of exercise on prostate cancer-specific anxiety, fear of cancer progression, quality of life and psychosocial outcomes in patients with prostate cancer on active surveillance. The ERASE (Exercise during Active Surveillance for Prostate Cancer) Trial randomized 52 patients with prostate cancer undergoing active surveillance to high-intensity interval training (HIIT, 26 patients) or usual care (UC, 26 patients). The HIIT group performed a 12-week, thrice weekly, supervised, aerobic HIIT program. The UC group did not exercise. Patient-reported outcomes were assessed at baseline and after intervention, including prostate cancer-specific anxiety (Memorial Anxiety Scale for Prostate Cancer), fear of cancer progression (Fear of Cancer Recurrence Inventory), prostate cancer symptoms (Expanded Prostate Cancer Index Composite), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core) and psychological health outcomes (eg fatigue, stress and self-esteem). Analysis of covariance was used to compare between-group differences. Fifty of 52 participants (96%) completed patient-reported outcome assessments at 12 weeks. Adherence to HIIT was 96%. Compared to UC, HIIT significantly improved total prostate cancer-specific anxiety (adjusted between-group mean difference -2.7, 95% confidence interval, range -5.0 to -0.4, p=0.024), as well as the fear of progression subscale (p=0.013), hormonal symptoms (p=0.005), perceived stress (p=0.037), fatigue (p=0.029) and self-esteem (p=0.007). A 12-week supervised HIIT program may improve prostate cancer-specific anxiety, fear of cancer progression, hormone symptoms, stress, fatigue and self-esteem in men with prostate cancer on active surveillance. Larger trials are needed to confirm the effects of HIIT on patient-reported outcomes in the active surveillance setting.

Association Between a 22-feature Genomic Classifier and Biopsy Gleason Upgrade During Active Surveillance for Prostate Cancer

BackgroundAlthough the Decipher genomic classifier has been validated as a prognostic tool for several prostate cancer endpoints, little is known about its role in assessing the risk of biopsy reclassification for patients on active surveillance, a key event that often triggers treatment. ObjectiveTo evaluate the association between Decipher genomic classifier scores and biopsy Gleason upgrading among patients on active surveillance. Design, setting, and participantsThis was a retrospective cohort study among patients with low- and favorable intermediate-risk prostate cancer on active surveillance who underwent biopsy-based Decipher testing as part of their clinical care. Outcome measurements and statistical analysisWe evaluated the association between the Decipher score and any increase in biopsy Gleason grade group (GG) using univariable and multivariable logistic regression. We compared the area under the receiver operating characteristic curve (AUC) for models comprising baseline clinical variables with or without the Decipher score. Results and limitationsWe identified 133 patients for inclusion with a median age of 67.7 yr and median prostate-specific of 5.6 ng/ml. At enrollment, 75.9% had GG1 and 24.1% had GG2 disease. Forty-three patients experienced biopsy upgrading. On multivariable logistic regression, the Decipher score was significantly associated with biopsy upgrading (odds ratio 1.37 per 0.10 unit increase, 95% confidence interval [CI] 1.05–1.79; p = 0.02). The Decipher score was associated with upgrading among patients with biopsy GG 1 disease, but not GG2 disease. The discriminative ability of a clinical model (AUC 0.63, 95% CI 0.51–0.74) was improved by integration of the Decipher score (AUC 0.69, 95% CI 0.58–0.80). ConclusionsThe Decipher genomic classifier score was associated with short-term biopsy Gleason upgrading among patients on active surveillance. Patient summaryThe results from this study indicate that among patients with prostate cancer undergoing active surveillance, those with higher Decipher scores were more likely to have higher-grade disease found over time. These findings indicate that the Decipher test might be useful for guiding the intensity of monitoring during active surveillance, such as more frequent biopsy for patients with higher scores.

A Feasibility Study of the Therapeutic Response and Durability of Short-term Androgen-targeted Therapy in Early Prostate Cancer Managed with Surveillance: The Therapeutics in Active Prostate Surveillance (TAPS01) Study

BackgroundActive surveillance (AS) is a preferred management option for men with prostate cancer with favourable prognosis. However, nearly half of men on AS switch to treatment within 5 years, so therapeutic strategies to prevent or delay disease progression could be considered. The androgen receptor is the pre-eminent oncogenic driver in prostate cancer. ObjectiveTo explore image-based tumour responses and the patient impact of short-duration androgen-targeted therapy (ATT) to abrogate disease progression during AS. Design, setting, and participantsMen on AS with Cambridge Prognostic Group 1 & 2 (low and favourable intermediate risk) prostate cancer and lesions visible on magnetic resonance imaging (MRI) were recruited to an open-label, single-centre, phase 2 feasibility study of short-term ATT (the TAPS01 study). InterventionApalutamide 240 mg was administered for 90 days. Outcome measurements and statistical analysisMRI-measured tumour volume (TV), gland volume (GV), and the TV/GV ratio were calculated at baseline, at day 90 (end of treatment), and at 6- and 18-month follow-up. Quality of life metrics were measured at day 0, day 90, and 6 weeks after ATT. Results and limitationsEleven patients (40% of eligible men approached) agreed to participate, of whom nine completed treatment. At day 90, the median percentage reduction was −38.2% (range −51.8% to −23.5%) for GV, −54.2% (range −74.1% to −13.8%) for TV, and −27.2% (range −61.5% to −7.5%) for TV/GV (all p < 0.0001). At 6 mo, while GV had returned to baseline (p = 0.95) both TV (−31.9%; p = 0.0007) and TV/GV (−28.7%; p = 0.0009) remained significantly reduced. This reduction was sustained at 18 months (TV −18%, TV/GV −23.8%; p = 0.01). European Organization for Research and Treatment of Cancer QoL core 30-item questionnaire scores for global, physical, role, and social functioning decreased during treatment, but all were recovering by 6 weeks. EQ-VAS scores were unchanged compared to baseline. ConclusionsTAPS01 has demonstrated feasibility and patient tolerability for short-term ATT in men on AS. Our data suggest a selective and durable antitumour effect in the short term and support a larger-scale randomised trial. Patient summaryWe investigated the feasibility of short-term treatment with an androgen inhibitor to prevent or delay disease progression for men on active surveillance for prostate cancer. Results for a small group of patients show that 90-day treatment led to a sustained decrease in tumour volume over 18 months. The findings warrant a larger clinical trial for this approach, which could allow patients to delay or even avoid longer-term active treatments.

A0278 - Predicting true pathologic Gleason grade during active surveillance for prostate cancer: Calibration of the Johns Hopkins ActiveCare Model in five large active surveillance cohorts

A0278 - Predicting true pathologic Gleason grade during active surveillance for prostate cancer: Calibration of the Johns Hopkins ActiveCare Model in five large active surveillance cohorts

A0751 - Diagnostic performance of micro-ultrasound guided reclassification biopsies in patients under active surveillance for prostate cancer

A0751 - Diagnostic performance of micro-ultrasound guided reclassification biopsies in patients under active surveillance for prostate cancer

A0280 - A phase II prospective trial of MRI and in-bore biopsy in the reclassification of men considering active surveillance for prostate cancer

A0280 - A phase II prospective trial of MRI and in-bore biopsy in the reclassification of men considering active surveillance for prostate cancer

A0269 - Active surveillance for prostate cancer: Uptake over time and the impact of an organized protocol

A0269 - Active surveillance for prostate cancer: Uptake over time and the impact of an organized protocol

Two Decades of Active Surveillance for Prostate Cancer in a Single-Center Cohort: Favorable Outcomes after Transurethral Resection of the Prostate.

Simple SummaryProstate cancer is the most commonly diagnosed cancer in men. Active surveillance—repeated measurements of prostate specific antigen, digital rectal examination, and prostate biopsies—is an alternative treatment option to active therapy, such as radical prostatectomy or radiotherapy, for patients with low grade prostate cancer. It aims to reduce overtreatment and negative side effects of active treatment. However, long-term outcome data is rare. As we prospectively collected data since the beginning of active surveillance in our clinic in 1999, our study provides insights into long-term outcomes after two decades of active surveillance.Objective: To report the outcomes of active surveillance (AS) for low-risk prostate cancer (PCa) in a single-center cohort. Patients and Methods: This is a prospective, single-center, observational study. The cohort included all patients who underwent AS for PCa between December 1999 and December 2020 at our institution. Follow-up appointments (FU) ended in February 2021. Results: A total of 413 men were enrolled in the study, and 391 had at least one FU. Of those who followed up, 267 had PCa diagnosed by transrectal ultrasound (TRUS)-guided biopsy (T1c: 68.3%), while 124 were diagnosed after transurethral resection of the prostate (TURP) (T1a/b: 31.7%). Median FU was 46 months (IQR 25–90). Cancer specific survival was 99.7% and overall survival was 92.3%. Median reclassification time was 11.2 years. After 20 years, 25% of patients were reclassified within 4.58 years, 6.6% opted to switch to watchful waiting, 4.1% died, 17.4% were lost to FU, and 46.8% remained on AS. Those diagnosed by TRUS had a significantly higher reclassification rate than those diagnosed by TURP (p < 0.0001). Men diagnosed by targeted MRI/TRUS fusion biopsy tended to have a higher reclassification probability than those diagnosed by conventional template biopsies (p = 0.083). Conclusions: Our single-center cohort spanning over two decades revealed that AS remains a safe option for low-risk PCa even in the long term. Approximately half of AS enrollees will eventually require definitive treatment due to disease progression. Men with incidental prostate cancer were significantly less likely to have disease progression.

Role of multi-parametric magnetic resonance imaging fusion biopsy in active surveillance of prostate cancer: a systematic review.

Background:Our goal is to review current literature regarding the role of multi-parametric magnetic resonance imaging (mpMRI) in the active surveillance (AS) of prostate cancer (PCa) and identify trends in rate of reclassification of risk category, performance of fusion biopsy (FB) versus systematic biopsy (SB), and progression-free survival.Methods:We performed a comprehensive literature search in PubMed and identified 121 articles. A narrative summary was performed.Results:Thirty-two articles were chosen to be featured in this review. SB and FB are complementary in detecting higher-grade disease in follow-up. While FB was more likely than SB to detect clinically significant disease, FB missed 6.4–11% of clinically significant disease. Imaging factors that predicted upgrading include number of lesions on magnetic resonance imaging (MRI), lesion density, and MRI suspicion level.Conclusion:Incorporating mpMRI FB in conjunction with SB should be part of contemporary AS protocols. mpMRI should additionally be used routinely for follow-up; however, mpMRI is not currently sensitive enough in detecting disease progression to replace biopsy in the surveillance protocol.

Active surveillance of prostate cancer – an ongoing concept

Active surveillance of prostate cancer – an ongoing concept

Pilot Study on the Impact of a Home-Based Exercise Program on Inflammatory Cytokines and Quality of Life in Men with Prostate Cancer Under Active Surveillance.

ObjectivesThis study aimed to demonstrate potential translation of pre-clinical studies to a home-based exercise intervention in mediating inflammatory cytokine markers and tumor progression in men under active surveillance for prostate cancer.MethodsA 2-arm randomized control parallel group design was used. The exercise intervention consisted of 24 weeks of an aerobic and resistance home-based exercise program and results were compared to a waitlist control group. Data were collected at baseline and end of study for eotaxin, interferon-γ (INF-γ), interleukin-12 (IL-12), interleukin-1α (IL-1α), interleukin-5 (IL-5), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF), distanced walked during a 6-minute walk test (6MWT), body mass index, and health-related quality of life.ResultsNon-significant decreases were observed in all biomarkers, especially VEGF (pre: 125.16 ± 198.66, post: 80.29 ± 124.30, P = .06) and INF-γ (pre: 152.88 ± 312.71, post: 118.93 ± 158.79, P = .08), in the intervention group; only IL- α (pre: 332.15 ± 656.77, post: 255.12 ± 502.09, P = .20) decreased in the control group while all other biomarkers increased from baseline to end of study. A non-significant increase in 6MWT distance was observed in the intervention group, while a decrease was seen in the control group. Significant decreases in physical function, emotional wellbeing, and total composite scale on the FACIT-F were observed in the intervention group, possibly due to the isolation restrictions of COVID-19. Physical function on the SF-36 significantly increased in the control group.ConclusionsFuture studies with powered samples are needed to confirm the trends observed for inflammatory biomarkers and functional fitness.

Establishment of Prospective Registry of Active Surveillance for Prostate Cancer: The Korean Urological Oncology Society Database.

To establish a prospective registry for the active surveillance (AS) of prostate cancer (PC) using the Korean Urological Oncology Society (KUOS) database and to present interim analysis. The KUOS registry of AS for PC (KUOS-AS-PC) was organized in May 2019 and comprises multiple institutions nationwide. The eligibility criteria were as follows: patients with (1) pathologically proven PC; (2) pre-biopsy prostate-specific antigen (PSA) ≤20 ng/mL; (3) International Society of Urological Pathology (ISUP) grade 1 or 2 (no cribriform pattern 4); (4) clinical T stage ≤T2c; (5) positive core ratio ≤50%; and (6) maximal cancer involvement in the core ≤50%. Detailed longitudinal clinical information, including multi-parametric magnetic resonance imaging and disease-specific outcomes, was recorded. From May 2019 to June 2021, 296 patients were enrolled, and 284 were analyzed. The mean±standard deviation (SD) age at enrollment was 68.7±8.2 years. The median follow-up period was 11.2 months (5.9-16.8 mo). Majority of patients had pre-biopsy PSA ≤10 ng/mL (91.2%), PSA density <0.2 ng/mL² (79.7%), ISUP grade group 1 (94.4%), single positive core (65.7%), maximal cancer involvement in the core ≤20% (78.1%), and clinical T stage of T1c or lower (72.9%). Fifty-two (18.3%) discontinued AS for various reasons. Interventions included radical prostatectomy (80.8%), transurethral prostatectomy (5.8%), primary androgen deprivation therapy (5.8%), radiation (5.8%), and focal therapy (1.9%). The mean±SD time to intervention was 8.9±5.2 months. The reasons for discontinuation included pathologic reclassification (59.6%), patient preference (25.0%), and radiologic reclassification (9.6%). Two (4.8%) patients with pathologic Gleason score upgraded to ISUP grade group 4, no biochemical recurrence. The KUOS established a successful prospective database of PC patients undergoing AS in Korea, named the KUOS-AS-PC registry.

Mindfulness-Based Stress Reduction for Men on Active Surveillance for Prostate Cancer and Their Spouses: Design and Methodology of a Randomized Controlled Trial

Mindfulness-Based Stress Reduction for Men on Active Surveillance for Prostate Cancer and Their Spouses: Design and Methodology of a Randomized Controlled Trial

Prostate Cancer Patients Under Active Surveillance with a Suspicious Magnetic Resonance Imaging Finding Are at Increased Risk of Needing Treatment: Results of the Movember Foundation’s Global Action Plan Prostate Cancer Active Surveillance (GAP3) Consortium

BackgroundThe inclusion criterion for active surveillance (AS) is low- or intermediate-risk prostate cancer. The predictive value of the presence of a suspicious lesion at magnetic resonance imaging (MRI) at the time of inclusion is insufficiently known. ObjectiveTo evaluate the percentage of patients needing active treatment stratified by the presence or absence of a suspicious lesion at baseline MRI. Design, setting, and participantsA retrospective analysis of the data from the multicentric AS GAP3 Consortium database was conducted. The inclusion criteria were men with grade group (GG) 1 or GG 2 prostate cancer combined with prostate-specific antigen <20 ng/ml. We selected a subgroup of patients who had MRI at baseline and for whom MRI results and targeted biopsies were used for AS eligibility. Suspicious MRI was defined as an MRI lesion with Prostate Imaging Reporting and Data System (PI-RADS)/Likert ≥3 and for which targeted biopsies did not exclude the patient for AS. Outcome measurements and statistical analysisThe primary outcome was treatment free survival (FS). The secondary outcomes were histological GG progression FS and continuation of AS (discontinuation FS). Results and limitationsThe study cohort included 2119 patients (1035 men with nonsuspicious MRI and 1084 with suspicious MRI) with a median follow-up of 23 (12–43) mo. For the whole cohort, 3-yr treatment FS was 71% (95% confidence interval [CI]: 69–74). For nonsuspicious MRI and suspicious MRI groups, 3-yr treatment FS rates were, respectively, 80% (95% CI: 77–83) and 63% (95% CI: 59–66). Active treatment (hazard ratio [HR] = 2.0, p < 0.001), grade progression (HR = 1.9, p < 0.001), and discontinuation of AS (HR = 1.7, p < 0.001) were significantly higher in the suspicious MRI group than in the nonsuspicious MRI group. ConclusionsThe risks of switching to treatment, histological progression, and AS discontinuation are higher in cases of suspicious MRI at inclusion. Patient summaryAmong men with low- or intermediate-risk prostate cancer who choose active surveillance, those with suspicious magnetic resonance imaging (MRI) at the time of inclusion in active surveillance are more likely to show switch to treatment than men with nonsuspicious MRI.

Magnetic Resonance Imaging-Guided Biopsy in Active Surveillance of Prostate Cancer.

The underlying premise of prostate cancer active surveillance (AS) is that cancers likely to metastasize will be recognized and eliminated before cancer-related disease can ensue. Our study was designed to determine the prostate cancer upgrading rate when biopsy guided by magnetic resonance imaging (MRGBx) is used before entry and during AS. The cohort included 519 men with low- or intermediate-risk prostate cancer who enrolled in prospective studies (NCT00949819 and NCT00102544) between February 2008 and February 2020. Subjects were preliminarily diagnosed with Gleason Grade Group (GG) 1 cancer; AS began when subsequent MRGBx confirmed GG1 or GG2. Participants underwent confirmatory MRGBx (targeted and systematic) followed by surveillance MRGBx approximately every 12 to 24 months. The primary outcome was tumor upgrading to ≥GG3. Upgrading to ≥GG3 was found in 92 men after a median followup of 4.8 years (IQR 3.1-6.5) after confirmatory MRGBx. Upgrade-free probability after 5 years was 0.85 (95% CI 0.81-0.88). Cancer detected in a magnetic resonance imaging lesion at confirmatory MRGBx increased risk of subsequent upgrading during AS (HR 2.8; 95% CI 1.3-6.0), as did presence of GG2 (HR 2.9; 95% CI 1.1-8.2) In men who upgraded ≥GG3 during AS, upgrading was detected by targeted cores only in 27%, systematic cores only in 25% and both in 47%. In 63 men undergoing prostatectomy, upgrading from MRGBx was found in only 5 (8%). When AS begins and follows with MRGBx (targeted and systematic), upgrading rate (≥GG3) is greater when tumor is initially present within a magnetic resonance imaging lesion or when pathology is GG2 than when these features are absent.