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

2020 ◽  
Author(s):  
Sonia Hur ◽  
Michael Tzeng ◽  
Eliza Cricco-Lizza ◽  
Miko Yu ◽  
Jessica Ancker ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Qualitative Study ◽  
Active Surveillance ◽  
Treatment Modality ◽  
Tertiary Care ◽  
Low Risk ◽  
Intermediate Risk ◽  
Perceptions And Attitudes ◽  
Partial Gland Ablation

Objectives - Partial 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). Design - 92 men diagnosed with very-low-risk, low-risk, and favorable intermediate-risk PCa on AS were invited to participate in semi-structured telephone interviews on PGA. Setting - Single tertiary care center located in New York City. Participants - 20 men with very-low-risk, low-risk, and favorable intermediate-risk PCa on AS participated in the interviews. Main outcome measures - Emerging themes on perceptions and attitudes toward PGA were developed from transcripts inductively coded and analyzed under standardized methodology. Results - Four themes were derived from twenty 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 9 men (45%) expressed interest at the current moment. Conclusions - Though 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.

Gleason upgrading with time in a large, active surveillance cohort with long-term follow-up.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
Suneil Jain ◽  
Danny Vesprini ◽  
Alexandre Mamedov ◽  
D. Andrew Loblaw ◽  
Laurence Klotz
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Linear Regression Analysis ◽  
Low Risk ◽  
Disease Rate ◽  
Intermediate Risk ◽  
Rate Of Increase ◽  
Long Term Follow Up

1 Background: Active surveillance (AS) is an accepted management strategy for localized prostate cancer. However, the rate of pathological upgrading has not been well described in mature study cohorts. Furthermore, concern exists over the possibility of prostate cancer dedifferentiation with time in patients on AS. Methods: Patients in our prospectively collected AS database with at least one repeat prostate biopsy were included. Linear regression analysis was used to estimate the proportion of patients upgraded (Gleason 6 to 3+4 or higher, Gleason 3+4 to 4+3 or higher) with time from diagnostic biopsy. Results: 593 of 862 patients in our cohort had at least one repeat biopsy. Median follow-up was 6.4 years (max. 20.2 years). The total number of biopsies ranged from 2 to 6. 20% of patients were intermediate risk, 0.3 % high risk, all others low risk. 31.2% of patients were upgraded during active surveillance. The proportion of patients upgraded increased with time, suggesting prostate cancer dedifferentiation occurred at a rate of 1.0%/year (95%CI -0.12 to 2.16%/year). The estimated rate of increase was 2.5 times higher in patients with intermediate risk disease at diagnosis (rate 1.9%/year, 95%CI -0.7-4.6) compared with those with low risk disease (rate 0.75%/year, 95%CI -0.5-2.0). Further analysis is underway. 62% of upgraded patients (n=114) went on to have active treatment. Patients who were upgraded and treated had significantly greater PSA velocities (median 1.2 ng/ml/y vs 0.42 ng/ml/y, p=0.01) and significantly higher Gleason scores when upgraded, than those who remained on surveillance (21.8% vs 2.8% Gleason 8-10, p<0.01). Conclusions: This is the largest re-biopsy cohort, with long-term follow-up, described to date, enabling the first estimates of prostate cancer dedifferentiation in patients on AS. Dedifferentiation rates appear higher in patients with intermediate risk prostate cancer compared with those who are low risk at baseline.

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.

Performance of MRI-TRUS-guided fusion biopsy to detect progression on active surveillance for low- and intermediate-risk prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 43-43
Author(s):  
Thomas P. Frye ◽  
Nabeel Ahmad Shakir ◽  
Steven Abboud ◽  
Arvin Koruthu George ◽  
Maria J Merino ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Low Risk ◽  
Intermediate Risk ◽  
Targeted Biopsy ◽  
Fusion Biopsy ◽  
Trus Biopsy ◽  
Guided Biopsy ◽  
Risk Prostate Cancer

43 Background: Active surveillance (AS) is an established treatment option for men with low risk prostate cancer. Its role in intermediate prostate cancer is still being investigated. Recent studies have shown that multiparametric-MRI (mp-MRI) along with MRI-TRUS fusion-guided biopsy may better assess risk in patients eligible for AS, compared to 12-core biopsy, due to improved detection of clinically significant cancers. The objective is to determine the performance of MRI-TRUS guided biopsy for men on AS with both low and intermediate risk disease. Methods: Between 2007-2014 men on AS were included if they had complete mp-MRI and pathology data for 2 or more MRI-TRUS biopsy sessions. Fusion guided biopsy procedures consisted of MRI identified targeted biopsies as well as random 12 core biopsies. Men were allowed to participate in AS with low and intermediate risk prostate cancer, Gleason score ≤ 3+4=7. Progression was defined by patients with initial Gleason 3+3=6 to any Gleason 4, and Gleason 3+4=7 disease progressing to a primary Gleason 4 or higher. Results: 89 men met our study criteria with an average age of 62 years old (range 45-79). 75 men had low risk Gleason 3+3=6 at the outset of AS by 1st biopsy session with a median PSA 5.1 ng/ml. The other 14 men had intermediate risk prostate cancer Gleason 3+4=7 at the outset of AS and a median PSA 4.6 ng/ml. During follow-up, 25 (33%) low risk men progressed to 3+4 or above at a median of 20.6 months. Of these, 19 were found by targeted biopsy. 6 (43%) of the intermediate risk men progressed to Gleason 4+3=7 at a median of 36.8 months. 4 of these progressed on targeted fusion biopsy. In the intermediate risk men, 84 random biopsy cores were require to detect 1 progression versus 15 targeted biopsy cores to detect 1 progression. Conclusions: The majority of patients on AS who progressed were identified by MRI-TRUS targeted biopsy. Less biopsy cores are required to detect progression with targeted biopsy. These results are preliminary and a larger cohort with longer follow-up would be beneficial.

Expanded criteria in men on active surveillance monitored by MRI-TRUS fusion biopsy.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 115-115
Author(s):  
Thomas P Frye ◽  
Steven F. Abboud ◽  
Richard Ho ◽  
Michele Fascelli ◽  
Raju Chelluri ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Low Risk ◽  
Intermediate Risk ◽  
Guided Biopsy ◽  
Risk Prostate Cancer ◽  
Expanded Criteria ◽  
Clinically Significant

115 Background: Active surveillance (AS) is an established option for men with prostate cancer. Studies have shown that multiparametric-MRI along with MRI-TRUS fusion-guided biopsy (FB) may better assess risk in patients eligible for AS, compared to 12-core biopsy, due to improved detection of clinically significant cancers. The objective is to evaluate the performance of expanded criteria eligibility in men on AS being monitored with MRI-TRUS guided biopsy. Methods: Men on AS were included if they had mp-MRI and pathology data for 2 or more FB sessions. FB procedures consisted of targeted biopsies and random 12 core biopsies. Men participated in AS with low and intermediate risk prostate cancer, Gleason score ≤ 3+4=7 with no restriction on percent core involvement or number of cores positive. Progression was defined by patients with initial Gleason 3+3=6 to any Gleason 4, and Gleason 3+4=7 disease progressing to a primary Gleason 4 or higher. Results: 124 men on AS met study criteria. Low risk men had a mean age of 61.3 years versus intermediate risk men with a mean age of 65.5 years (p=0.0062). Mean PSA levels of the low and intermediate risk groups were 5.8 and 5.76 ng/ml (p=0.95), respectively. The mean length of follow-up was 22.56 months (range: 3.6 – 74.4 mo). Rates of pathologic progression in the intermediate and low risk patients were, 38.5% vs. 28.5% (p=0.33). Intermediate risk men had a mean progression-free survival (PFS) of 2.8 years compared to low risk men of 3.9 years (p=0.27). Patients were stratified according to established AS criteria (Epstein, Toronto, PRIAS) and rates of progression are summarized in the Table. 69% of patients met Epstein criteria for AS of which 29.4% (20/68) progressed compared to 28.5% for the low risk cohort overall. Conclusions: Men in our cohort who met strict criteria for AS had the same rate of progression as the entire expaned criteria low risk cohort, 29.4% vs 28.5%, respectively. Our data suggests that with accurate initial Gleason classification other AS criteria such as percent core or number of cores positive have no added benefit in predicting which men may have reclassification or progression of disease. [Table: see text]

Perspectives of prostate cancer patients about active surveillance.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 82-82
Author(s):  
Fred Saad ◽  
Margaret Fitch ◽  
Kittie Pang ◽  
Veronique Ouellet ◽  
Carmen Loiselle ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Active Surveillance ◽  
Health Care Professionals ◽  
Treatment Options ◽  
Low Risk ◽  
Close Monitoring ◽  
Focus Group Interviews ◽  
Group Interviews

82 Background: In prostate cancer (PC), men diagnosed with low risk disease may be monitored through an active surveillance (AS) approach that runs counter to the traditional message of undergoing treatment as soon as possible following a cancer diagnosis. This research explored the perspectives of men with PC regarding their decision-making process for AS to identify the factors that influenced their decision and assisted health care professionals in discussing AS as an option. Methods: Focus group interviews (n = 7) were held in several Canadian cities with men (n = 52) diagnosed with PC and eligible for AS. The men’s viewpoints were captured regarding their understanding of AS, the factors that influenced their decision to engage in AS, and their experience with the approach. A content and theme analysis was performed on the verbatim transcripts from the interviews. Results: All patients described the perception that their disease was not “large enough” to require treatment. They understood that the waiting process avoided the side effects associated with treatments, and they were comfortable about postponing treatment while undergoing close monitoring. Conversations with their doctor and how AS was described were cited as key influences in their decision. Other influences included availability of information on treatment options, distrust in the health system, personality, experiences and opinions of others, and personal perspectives on quality of life. Conclusions: AS is a relatively new approach for the care of men with low risk PC. Men require a thorough explanation on AS as a safe and valid option, as well as guidance towards supportive resources in their decision-making.

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.

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