scholarly journals Outcomes of Active Surveillance for Men With Intermediate-Risk Prostate Cancer

2011 ◽  
Vol 29 (2) ◽  
pp. 228-234 ◽  
Author(s):  
Matthew R. Cooperberg ◽  
Janet E. Cowan ◽  
Joan F. Hilton ◽  
Adam C. Reese ◽  
Harras B. Zaid ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
San Francisco ◽  
Active Surveillance ◽  
Active Treatment ◽  
Early Stage ◽  
Specific Antigen ◽  
Low Risk ◽  
Gleason Grade ◽  
Intermediate Risk ◽  
Positive Biopsy

Purpose Active surveillance (AS) is an option for the initial management of early-stage prostate cancer. Current risk stratification schema identify patients with low-risk disease who are presumed to be most suitable for AS. However, some men with higher risk disease also elect AS; outcomes for such men have not been widely reported. Patients and Methods Men managed with AS at University of California, San Francisco, were classified as low- or intermediate-risk based on serum prostate-specific antigen (PSA), Gleason grade, extent of biopsy involvement, and T stage. Clinical and demographic characteristics, and progression in terms of Gleason score, PSA kinetics, and active treatment were compared between men with low- and intermediate-risk tumors. Results Compared to men with low-risk tumors, those with intermediate-risk tumors were older (mean, 64.9 v 62.3 years) with higher mean PSA values (10.9 v 5.1 ng/mL), and more tumor involvement (mean, 20.4% v 15.3% positive biopsy cores; all P < .01). Within 4 years of the first positive biopsy, the clinical risk group did not differ in terms of the proportions experiencing progression-free survival, (low [54%] v intermediate [61%]; log-rank P = .22) or the proportions who underwent active treatment (low [30%] v intermediate [35%]; log-rank P = .88). Among men undergoing surgery, none were node positive and none had biochemical recurrence within 3 years. Conclusion Selected men with intermediate-risk features be appropriate candidates for AS, and are not necessarily more likely to progress. AS for these men may provide an opportunity to further reduce overtreatment of disease that is unlikely to progress to advanced cancer.

Gleason score upgrade among 10,282 men who underwent surgery as initial treatment in 2010: A population-based study.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 72-72
Author(s):  
Hong Zhang ◽  
Edward M. Messing ◽  
Hamza Ahmed ◽  
Yuhchyau Chen
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Specific Antigen ◽  
Low Risk ◽  
Categorical Variables ◽  
Intermediate Risk ◽  
Time Of Surgery ◽  
Significant Difference ◽  
Risk Prostate Cancer

72 Background: Active surveillance is now accepted initial management for men who have localized prostate cancer with low risk of disease progression. Many criteria have been used for patient identification, including Gleason score (GS) obtained from prostate biopsy. Because of concerns of sampling error, some have recommended repeated biopsy before committing to active surveillance. However, there is limited information about the risk of missing high grade disease using the current standard biopsy approach. This study seeks to compare GS difference from biopsy and surgery to provide an estimated rate of GS upgrade. Methods: The Surveillance, Epidemiology, and End Results (SEER) program was used to identify men with American Joint Committee on Cancer stage T1-2cN0M0 prostate cancer diagnosed between January 2010 and December 2010. Patients who underwent prostatectomy were selected for further analysis. Based on prostate-specific antigen (PSA) levels and GS, cases were divided into low (PSA <=10 and GS <=6) and intermediate (10<PSA<=20 or GS=7) risk groups. The rates of GS upgrade were reported for each group. Chi-square tests were used to assess differences in categorical variables (e.g. age and race) between groups of GS upgrade and no change/downgrade. Results: A total of 10,282 men were evaluated, with 9.2% (n=942) having low-risk disease, and 90.8% (n=9340) having intermediate-risk disease. Among men with low-risk prostate cancer, 22.3% (n=210) had GS upgrade and 0.8% (n=8) had GS 8 disease. Among men with intermediate risk disease, 26.2% (n=2446) had GS upgrade and 2.3% (n=214) had GS 8 disease. There was no statistically significant difference in either age or race distribution among men who had GS upgrade versus no change or downgrade at the time of surgery. Conclusions: A substantial number of low- and intermediate-risk prostate cancer patients had GS upgrade at the time of surgery, but few had upgraded to GS 8 high risk disease. These observations suggest that repeat biopsy prior to active surveillance may not be necessary.

scholarly journals Changes in Prostate Cancer Grade on Serial Biopsy in Men Undergoing Active Surveillance

2011 ◽  
Vol 29 (20) ◽  
pp. 2795-2800 ◽  
Author(s):  
Sima P. Porten ◽  
Jared M. Whitson ◽  
Janet E. Cowan ◽  
Matthew R. Cooperberg ◽  
Katsuto Shinohara ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Gleason Score ◽  
Sampling Error ◽  
Survival Rates ◽  
Specific Antigen ◽  
Extended Period ◽  
Low Risk ◽  
Gleason Grade

Purpose Active surveillance is now considered a viable treatment option for men with low-risk prostate cancer. However, little is known regarding changes in Gleason grade on serial biopsies over an extended period of time. Patients and Methods Men diagnosed with prostate cancer between 1998 and 2009 who elected active surveillance as initial treatment, with 6 or more months of follow-up and a minimum of six cores at biopsy, were included in analysis. Upgrading and downgrading were defined as an increase or decrease in primary or secondary Gleason score. Means and frequency tables were used to describe patient characteristics, and treatment-free survival rates were determined by life-table product limit estimates. Results Three hundred seventy-seven men met inclusion criteria. Mean age at diagnosis was 61.9 years. Fifty-three percent of men had prostate-specific antigen of 6 ng/mL or less, and 94% had Gleason score of 6 or less. A majority of men were cT1 (62%), had less than 33% of biopsy cores involved (80%), and were low risk (77%) at diagnosis. Median number of cores taken at diagnostic biopsy was 13, mean time to follow-up was 18.5 months, and 29% of men had three or more repeat biopsies. Overall, 34% (129 men) were found to have an increase in Gleason grade. The majority of men who experienced an upgrade (81%) did so by their second repeat biopsy. Conclusion A proportion of men experience an upgrade in Gleason score while undergoing active surveillance. Men who experience early upgrading likely represent initial sampling error, whereas later upgrading may reflect tumor dedifferentiation.

scholarly journals No detrimental effect of a positive family history on postoperative upgrading and upstaging in men with low risk and favourable intermediate-risk prostate cancer: implications for active surveillance

2020 ◽  
Author(s):  
Kathleen Herkommer ◽  
Nikola Maier ◽  
Donna P. Ankerst ◽  
Stefan Schiele ◽  
Jürgen E. Gschwend ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Family History ◽  
Active Surveillance ◽  
Detrimental Effect ◽  
Clinical Decision Making ◽  
Positive Family History ◽  
Low Risk ◽  
Gleason Grade ◽  
Intermediate Risk ◽  
History Of

Abstract Purpose To assess whether a first-degree family history or a fatal family history of prostate cancer (PCa) are associated with postoperative upgrading and upstaging among men with low risk and favourable intermediate-risk (FIR) PCa and to provide guidance on clinical decision making for active surveillance (AS) in this patient population. Methods Participants in the German Familial Prostate Cancer database diagnosed from 1994 to 2019 with (1) low risk (clinical T1c–T2a, biopsy Gleason Grade Group (GGG) 1, PSA < 10 ng/ml), (2) Gleason 6 FIR (clinical T1c–T2a, GGG 1, PSA 10–20 ng/ml), and (3) Gleason 3 + 4 FIR (clinical T1c–T2a, GGG 2, PSA < 10 ng/ml) PCa who were subsequently treated with radical prostatectomy (RP) were analysed for upgrading, defined as postoperative GGG 3 tumour or upstaging, defined as pT3–pT4 or pN1 disease at RP. Logistic regression analysis was used to assess whether PCa family history was associated with postoperative upgrading or upstaging. Results Among 4091 men who underwent RP, mean age at surgery was 64.4 (SD 6.7) years, 24.7% reported a family history, and 3.4% a fatal family history. Neither family history nor fatal family history were associated with upgrading or upstaging at low risk, Gleason 6 FIR, and Gleason 3 + 4 FIR PCa patients. Conclusion Results from the current study indicated no detrimental effect of family history on postoperative upgrading or upstaging. Therefore, a positive family history or fatal family history of PCa in FIR PCa patients should not be a reason to refrain from AS in men otherwise suitable.

scholarly journals Genetic Factors Associated with Prostate Cancer Conversion from Active Surveillance to Treatment

2021 ◽  
Author(s):  
Yu Jiang ◽  
Travis J. Meyers ◽  
Adaeze A. Emeka, ◽  
Lauren Folgosa Cooley ◽  
Phillip R. Cooper ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Active Treatment ◽  
Genetic Factors ◽  
Genome Wide Association Study ◽  
Genetic Risk Score ◽  
Specific Antigen ◽  
Low Risk ◽  
Nucleotide Polymorphisms ◽  
Initial Management

Men diagnosed with low-risk prostate cancer (PC) are increasingly electing active surveillance (AS) as their initial management strategy. While this may reduce the side effects of treatment for prostate cancer, many men on AS eventually convert to active treatment. PC is one of the most heritable cancers, and genetic factors that predispose to aggressive tumors may help distinguish men who are more likely to discontinue AS. To investigate this, we undertook a multi-institutional genome-wide association study (GWAS) of 6,361 PC patients who initially elected AS and were followed over time for the potential outcome of conversion from AS to active treatment. In the GWAS we detected 18 single nucleotide polymorphisms (SNPs) associated with conversion, 15 of which were not previously associated with PC risk. We found two genes associated with conversion (MAST3, p = 6.9×10-7 and GAB2, p = 2.0×10-6). Moreover, increasing values of a previously validated 269-SNP genetic risk score (GRS) for PC was positively associated with conversion (e.g., comparing the highest to the two middle deciles gave a hazard ratio [HR] = 1.13; 95% Confidence Interval [CI]= 0.94-1.36); whereas, decreasing values of a 36-variant GRS for prostate-specific antigen (PSA) levels were positively associated with conversion (e.g., comparing the lowest to the two middle deciles gave a HR = 1.25; 95% CI, 1.04-1.50). These results suggest that germline genetics may help inform and individualize the decision of AS-or the intensity of monitoring on AS-versus treatment for the initial management of patients with low-risk PC.

scholarly journals Active surveillance in intermediate-risk prostate cancer with PSA 10–20 ng/mL: pathological outcome analysis of a population-level database

2021 ◽  
Author(s):  
Peter E. Lonergan ◽  
Chang Wook Jeong ◽  
Samuel L. Washington ◽  
Annika Herlemann ◽  
Scarlett L. Gomez ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
Outcome Analysis ◽  
Risk Category ◽  
Gleason Grade ◽  
Intermediate Risk ◽  
Grade Group ◽  
Risk Prostate Cancer

Abstract Background Active surveillance (AS) is generally recognized as the preferred option for men with low-risk prostate cancer. Current guidelines use prostate-specific antigen (PSA) of 10–20 ng/mL or low-volume biopsy Gleason grade group (GG) 2 as features that, in part, define the favorable intermediate-risk disease and suggest that AS may be considered for some men in this risk category. Methods We identified 26,548 men initially managed with AS aged <80 years, with clinically localized prostate cancer (cT1-2cN0M0), PSA ≤ 20 ng/mL, biopsy GG ≤ 2 with percent positive cores ≤33% and who converted to treatment with radical prostatectomy from the surveillance, epidemiology, and end results prostate with the watchful waiting database. Multivariable logistic regression was performed to determine predictors of adverse pathology at RP according to PSA level (<10 vs 10–20 ng/mL) and GG (1 vs 2). Results Of 1731 men with GG 1 disease and PSA 10–20 ng/mL, 382 (22.1%) harbored adverse pathology compared to 2340 (28%) of 8,367 men with GG 2 and a PSA < 10 ng/mL who had adverse pathology at RP. On multivariable analysis, the odds of harboring adverse pathology with a PSA 10–20 ng/mL (odds ratio [OR] 1.87, 95% confidence interval [CI] 1.71–2.05, p < 0.001) was less than that of GG 2 (OR 2.56, 95%CI 2.40–2.73, p < 0.001) after adjustment. Conclusions Our results support extending AS criteria more permissively to carefully selected men with PSA 10–20 ng/mL and GG 1 disease.

scholarly journals Outcomes of active surveillance for clinically localized prostate cancer in a middle eastern tertiary care center

2021 ◽  
Vol 93 (4) ◽  
pp. 385-388
Author(s):  
Mohammad Hout ◽  
Ali Merhe ◽  
Nassib Abou Heidar ◽  
Jose M. El-Asmar ◽  
Wassim Wazzan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Active Treatment ◽  
Tertiary Care ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Low Risk ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer

Background: The aim of our study was to evaluate the outcome of active surveillance (AS) for prostate cancer for a cohort of patients at our institution. Methods: A total of 43 patients with low risk prostate cancer were enrolled in an active surveillance pilot program at our institution between 2008 and 2018. Follow up protocols included: periodic prostate specific antigen (PSA), digital rectal examination (DRE), multiparametric MRI, and prostate biopsy at one year. Pertinent parameters were collected, and descriptive statistics were reported along with a subset analysis of patients that dropped out of the protocol to receive active treatment for disease progression. Results: Out of 43 eligible patients, 46.5% had a significant rise in follow up PSA. DRE was initially suspicious in 27.9% of patients, and none had any change in DRE on follow up. Initially, prostate MRIs showed PIRADS 3, 4, and 5 in 14%, 37.2%, and 11.6% respectively, while 23.2% had a negative initial MRI. 14% did not have an MRI. Upon follow up, 18.6% of patients had progression on MRI. Initial biopsies revealed that 86% were classified as WHO group 1, while 14% as WHO group 2. With regards to the follow up biopsies, 11.6% were upgraded. 20.9% of our patients had active treatment; 44.4% due to upgraded biopsy results, 22.2% due to PSA progression, 22.2% due to strong patient preference, and 11.1% due to radiologic progression. Conclusions: For selected men with low risk prostate cancer, AS is a reasonable alternative. The decision for active treatment should be tailored upon changes in PSA, DRE, MRI, and biopsy results.

Active Surveillance for Low-risk Prostate Cancer: Are All Criteria Similar?

2018 ◽  
Vol 18 (7) ◽  
pp. 958-963
Author(s):  
Sebastiano Cimino ◽  
Salvatore Privitera ◽  
Vincenzo Favilla ◽  
Francesco Cantiello ◽  
Stefano Manno ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Life Expectancy ◽  
Active Surveillance ◽  
English Language ◽  
Early Stage ◽  
Meta Analysis ◽  
Low Risk ◽  
Intermediate Risk ◽  
Monitoring Methods ◽  
Deferred Treatment

Background: Active Surveillance (AS) is a therapeutic strategy for early-stage Prostate Cancer (PCa) conceived to balance early detection of aggressive disease and overtreatment of indolent tumor. Several active surveillance protocols have been published over the years, however the risk of misclassification still exist. In this review, we revised the current criteria of AS and evaluated the characteristics of potential risk factors of misclassification or deferred treatment. Methods: We did a systematic search of the MEDLINE database, from 1993 to May 2015, according to Preferred Reporting Items for Systematic Reviews and Meta-analysis statement guidelines and limited to the English language. The search terms used included “prostate cancer” and “active surveillance” and “criteria. We have excluded from the study reviews and editorial comments as well as multiple papers from the same data sets. Results: Although the follow-up of reported studies was a quite short compared to the duration of the disease, the data are sufficient to conclude that active surveillance should be offered to men with low-risk disease and to men with intermediate risk and poor life expectancy. The present challenge, in fact, is to differentiate the clinically silent disease from the unfavorable course by identifying the right timing for any deferred treatment. This is made particularly difficult by the absence of randomized controlled trials directly comparing different AS monitoring methods. Conclusion: As summarized in this review, it is still difficult to select patients eligible for active surveillance and differentiate them from those that should move to active treatment. From the data, currently available in the literature, however, it is possible to recommend active surveillance to men with low-risk disease and to men with intermediate-risk disease but with short life expectancy.

scholarly journals Perceptions of partial gland ablation for prostate cancer among men on active surveillance: a qualitative study

2021 ◽  
Vol 3 (1) ◽  
pp. e000068
Author(s):  
Sonia Hur ◽  
Michael Tzeng ◽  
Eliza Cricco-Lizza ◽  
Spyridon Basourakos ◽  
Miko Yu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Qualitative Study ◽  
Active Surveillance ◽  
Treatment Modality ◽  
Tertiary Care ◽  
Low Risk ◽  
Intermediate Risk ◽  
Perceptions And Attitudes ◽  
Partial Gland Ablation

ObjectivesPartial gland ablation (PGA) therapy is an emerging treatment modality that targets specific areas of biopsy-proven prostate cancer (PCa) to minimize treatment-related morbidity by sparing benign prostate. This qualitative study aims to explore and characterize perceptions and attitudes toward PGA in men with very-low-risk, low-risk, and favorable intermediate-risk PCa on active surveillance (AS).Design92 men diagnosed with very-low-risk, low-risk, and favorable intermediate-risk PCa on AS were invited to participate in semistructured telephone interviews on PGA.SettingSingle tertiary care center located in New York City.Participants20 men with very-low-risk, low-risk, and favorable intermediate-risk PCa on AS participated in the interviews.Main outcome measuresEmerging themes on perceptions and attitudes toward PGA were developed from transcripts inductively coded and analyzed under standardized methodology.ResultsFour themes were derived from 20 interviews that represent the primary considerations in treatment decision-making: (1) the feeling of psychological safety associated with low-risk disease; (2) preference for minimally invasive treatments; (3) the central role of the physician; (4) and the pursuit of treatment options that align with disease severity. Eleven men (55%) expressed interest in pursuing PGA only if their cancer were to progress, while nine men (45%) expressed interest at the current moment.ConclusionsAlthough an emerging treatment modality, patients were broadly accepting of PGA for PCa, with men primarily debating the risks versus benefits of proactively treating low-risk disease. Additional research on men’s preferences and attitudes toward PGA will further guide counseling and shared decision-making for PGA.

scholarly journals Prostate Cancer Grade and Stage Misclassification in Active Surveillance Candidates: Black Versus White Patients

2020 ◽  
Vol 18 (11) ◽  
pp. 1492-1499
Author(s):  
Lara Franziska Stolzenbach ◽  
Giuseppe Rosiello ◽  
Angela Pecoraro ◽  
Carlotta Palumbo ◽  
Stefano Luzzago ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Temporal Trend ◽  
Low Risk ◽  
Intermediate Risk ◽  
Multivariate Logistic Regression ◽  
Black Patients ◽  
Risk Prostate Cancer ◽  
Misclassification Rates ◽  
White Patients

Background: Misclassification rates defined as upgrading, upstaging, and upgrading and/or upstaging have not been tested in contemporary Black patients relative to White patients who fulfilled criteria for very-low-risk, low-risk, or favorable intermediate-risk prostate cancer. This study aimed to address this void. Methods: Within the SEER database (2010–2015), we focused on patients with very low, low, and favorable intermediate risk for prostate cancer who underwent radical prostatectomy and had available stage and grade information. Descriptive analyses, temporal trend analyses, and multivariate logistic regression analyses were used. Results: Overall, 4,704 patients with very low risk (701 Black vs 4,003 White), 17,785 with low risk (2,696 Black vs 15,089 White), and 11,040 with favorable intermediate risk (1,693 Black vs 9,347 White) were identified. Rates of upgrading and/or upstaging in Black versus White patients were respectively 42.1% versus 37.7% (absolute Δ = +4.4%; P<.001) in those with very low risk, 48.6% versus 46.0% (absolute Δ = +2.6%; P<.001) in those with low risk, and 33.8% versus 35.3% (absolute Δ = –1.5%; P=.05) in those with favorable intermediate risk. Conclusions: Rates of misclassification were particularly elevated in patients with very low risk and low risk, regardless of race, and ranged from 33.8% to 48.6%. Recalibration of very-low-, low-, and, to a lesser extent, favorable intermediate-risk active surveillance criteria may be required. Finally, our data indicate that Black patients may be given the same consideration as White patients when active surveillance is an option. However, further validations should ideally follow.

Phase 2b trial results of padeliporfin (WST11 or Tookad) vascular-targeted photodynamic therapy for partial gland ablation in men with intermediate-risk prostate cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17006-e17006
Author(s):  
Jonathan Coleman ◽  
Daniel D. Sjoberg ◽  
Quinlan Demac ◽  
Catriona ODea ◽  
Marlena McGill ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Primary Endpoint ◽  
Low Risk ◽  
Gleason Grade ◽  
Intermediate Risk ◽  
Function Score ◽  
Trus Biopsy ◽  
Risk Prostate Cancer ◽  
Partial Gland Ablation ◽  
Targeted Photodynamic Therapy

e17006 Background: Padeliporfin (WST11) vascular-targeted photodynamic therapy (VTP) has shown significant clinical benefit as a localized partial gland ablation (PGA) therapy when compared to active surveillance for low-risk prostate cancer, by curbing progression and the need for radical treatment, leading to its regulatory approval in Europe. This phase 2b trial prospectively investigated WST11-VTP for intermediate-risk cancers. Methods: Men with unilateral Grade Group 2 (GG2) cancers (Gleason 3+4), evaluated with MRI and ultrasound-guided (TRUS) biopsy, underwent up to two WST11-VTP PGA sessions. Eligibility criteria included <cT2b, PSA < 10, and fusion biopsy for PIRADS 3+ lesions on pretreatment MRI. Contralateral very low–risk disease was observed. The primary endpoint was prevalence of any Gleason Grade 4 or 5 (≥GG2) cancer, determined by MRI and systematic, 14-core TRUS biopsy of the entire gland (+/- fusion) at 3 and 12 months after treatment. Treatment safety and patient-reported quality of life for sexual and urinary function were assessed with validated questionnaires (IIEF-15 and IPSS, respectively). The study was powered using β = 0.2 to reject the null hypothesis (r≤70%), using a one-sided exact binomial test with 5% alpha risk. To be valid, 44 evaluable patients were required for the 12-month primary endpoint assessment. Results: Of the 50 men treated, 46 were evaluable for the 12-month primary endpoint. Before 12 months, 1 man proceeded to prostatectomy (treatment failure), 2 men refused 12-month biopsy, and 1 man died of COVID-19. At 3 months, 12/49 (24%) men underwent per protocol second WST11-VTP PGA session for GG2 tumor: 9 for residual cancer and 4 for newly identified contralateral GG2 tumors (1 bilateral). The 12-month biopsy was performed in 45 men; 38 (83%) had no Gleason grade 4 or 5 cancer, including 11/12 (92%) patients who underwent 2 PGA sessions. By 3 months, median decline in erectile function score (IIEF-5) from baseline was -1.0 (IQR -7,0). Median improvement in urinary function score (IPSS) was -1.0 (IQR -1,5), with pad-free continence observed in all patients. Median change in IIEF score by 12-months was -1.0 (IQR -5,0). Grade 3 treatment-related adverse events occurred in 6 (12%) patients. All procedure-related prostate/pelvic pain resolved by 3 weeks. Conclusions: The positive results from this trial show that WST11-VTP is effective for PGA of intermediate-risk prostate cancer, with minimal toxicity or impact on urinary and sexual function, consistent with the phase 3 trial results in low-risk disease. Based on these data, this therapy bears consideration for approval as a conservative therapeutic option for selected cases of intermediate-risk disease. Clinical trial information: NCT03315754.

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