scholarly journals MP66-03 AMONG MEN WITH GLEASON GRADE GROUP 3, INTERMEDIATE-RISK PROSTATE CANCER, STAGE CT2 IS ASSOCIATED WITH METASTATIC RECURRENCE

2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
John Cooper* ◽  
Mufaddal Mamawala ◽  
Jason Cohen ◽  
Jeffrey Tosoian ◽  
Misop Han ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gleason Grade ◽  
Cancer Stage ◽  
Intermediate Risk ◽  
Grade Group ◽  
Metastatic Recurrence ◽  
Risk Prostate Cancer ◽  
Group 3 ◽  
Prostate Cancer Stage

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.

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.

Impact of initial treatment selection on clinical outcomes after biochemical failure in radiorecurrent high-risk prostate cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 208-208
Author(s):  
Rebecca Levin-Epstein ◽  
Tahmineh Romero ◽  
Jessica Karen Wong ◽  
Kiri Cook ◽  
Robert Timothy Dess ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Initial Treatment ◽  
External Beam Radiotherapy ◽  
Oncologic Outcomes ◽  
Gleason Grade ◽  
Grade Group ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Median Interval

208 Background: Treatment of high risk prostate cancer (HRPCa) with external beam radiotherapy (EBRT) plus brachytherapy (BT) boost (EBRT+BT) has been prospectively associated with lower rates of BCR, albeit potentially with increased toxicity, and retrospectively linked to decreased distant metastasis (DM) and PCa-specific mortality (PCSM) compared to EBRT alone. However, it is unclear whether patients who develop BCR following either approach have similar downstream oncologic outcomes. Methods: We identified 706 out of 3820 men with HRPCa treated at 13 institutions from 1998-2015 with EBRT (n=468/2134) or EBRT+BT (n=238/1686) who developed BCR. We compared rates of DM, PCSM, and all-cause mortality (ACM) after BCR between treatment groups using Fine-Gray competing risk regression. Models were adjusted for age, Gleason grade group, initial PSA (iPSA), clinical T stage, time-dependent use of systemic salvage, and interval to BCR using inverse probability of treatment weighting. Results: Median follow-up was 9.9 years from RT and 4.8 years from BCR. Groups were similar in age, iPSA, presence of ≥2 HR features, and median interval to BCR (3.3 years). Most men received neoadjuvant/concurrent androgen deprivation therapy (ADT), 92.5% and 91.0% for EBRT and EBRT+BT, respectively, though for a longer duration with EBRT (median 14.7 vs. 9.0 months, p=0.0012). Local and systemic salvage rates were 2.3% and 36.3% after EBRT, and 2.6% and 43.6% after EBRT+BT, respectively. Initial EBRT+BT was associated with significantly lower rates of DM after BCR (HR 0.48, 95% CI 0.36-0.64, p<0.001). Rates of PCSM and ACM did not significantly differ (HR 0.93, 95% CI 0.67-1.30, p=0.93, and HR 0.8, 95% CI 0.6-1.1, p=0.11, respectively). Conclusions: In this large retrospective series of radiorecurrent HRPCa, initial treatment with EBRT+BT was associated with significantly lower rates of DM after BCR compared with EBRT, despite shorter ADT use and a similar median interval to BCR. Local salvage was widely underutilized in both groups. In the absence of salvage for local failure after EBRT, upfront treatment intensification with BT may reduce DM, though not PCSM or ACM, even after development of BCR.

scholarly journals Tumour growth rates of prostate cancer during active surveillance: is there a difference between MRI-visible low and intermediate-risk disease?

2021 ◽  
pp. 20210321
Author(s):  
Francesco Giganti ◽  
Clare Allen ◽  
Vasilis Stavrinides ◽  
Armando Stabile ◽  
Aiman Haider ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Growth Rate ◽  
Active Surveillance ◽  
Gleason Grade ◽  
Annual Growth Rate ◽  
Intermediate Risk ◽  
Grade Group ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

Objectives: The aim of this study was to evaluate the changes in lesion volume on serial multiparametric magnetic resonance (mpMRI) during active surveillance for prostate cancer. Methods: A total of 160 patients with a targeted biopsy-confirmed visible lesion on mpMRI, stratified by low- and intermediate-risk disease (Gleason Grade Group 1 vs Gleason Grade Group 2), were analysed. The % change per year was calculated using the formula: [(final volume/initial volume) exp (1/interval between scans in years)]-1. Results: There was no significant difference in the annual median percentage change between Gleason Grade Group 1 (18%) and Gleason Grade Group 2 (23%) disease (p = 0.16), and between ≤ 10% (23%) and > 10% (22%) of Gleason pattern 4 (p = 0.78). Assuming a spherical lesion, these changes corresponded to annual increases in mean tumour diameter of 6% and 7% for Gleason Grade Group 1 and Gleason Grade Group 2 respectively, which may be less than the interscan variability of serial mpMRI. Conclusion: In an active surveillance cohort, we did not see a significant difference in the annual growth rate of Gleason Grade Group 1 and 2 tumours. Advances in knowledge: In patients on active surveillance, the measured growth rates for visible tumours in Gleason Grade Groups 1 and 2 were similar. The annual growth rate was small in most cases and this may have implications for the MRI follow-up interval in active surveillance.

When can active surveillance be less active? Prediction of long-term nonreclassification for men with low-risk prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 140-140
Author(s):  
Matthew R. Cooperberg ◽  
Anna V Faino ◽  
Lisa F Newcomb ◽  
Peter Carroll ◽  
James T Kearns ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Management Strategy ◽  
Low Risk ◽  
Gleason Grade ◽  
Grade Group ◽  
Dynamic Risk ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer ◽  
Dynamic Risk Prediction

140 Background: Active surveillance is endorsed as the preferred management strategy for most men with low-risk prostate cancer. However, nearly all active surveillance protocols entail prostate specific antigen (PSA) testing every 3-6 months, and prostate biopsies every 1-2 years. For many men with indolent tumors, this regimen is overly intense, and exposes men to the discomfort, risks, and costs of repeated biopsies. We aimed to determine if some men can be safely selected for a less intense surveillance regimen by predicting the probability of non-reclassification over the next 4 years of surveillance. Methods: Data were collected from men in the multicenter Canary Prostate Active Surveillance Study (PASS), in which PSAs are collected q3 months and biopsies performed 12 months of diagnosis and then every 2 years. For inclusion in this study, men had to have undergone ≤ 1 follow up biopsy, and have Gleason grade group 1 at diagnosis. Reclassification was defined as increase in Gleason grade group on subsequent biopsy; those without reclassification were censored at last study contact, treatment or 2 years after last biopsy. A dynamic risk prediction model based on a Cox regression with robust variance estimates was used to construct and test a model predicting non-reclassification. Results: Of 1082 men included, 362 (33%) reclassified and the remaining were censored. The final regression model included percent of biopsy cores involved, prior biopsy history, time since diagnosis, BMI, prostate size, diagnostic PSA, and PSAk (a measure of PSA kinetics). This dynamic risk prediction model was assessed at a measurement time of 1 year after diagnosis, predicting risk of reclassification at 4 years. Men at lowest and highest deciles of this model-based risk faced 6% (95%CI 0-12%) and 73% (55-84%) risks of reclassification within 5 years. For at least 10% of the men in the cohort, the negative predictive value (NPV) for reclassification was 95% or higher. Conclusions: A substantial proportion of men with low-risk prostate cancer can safely be followed with a de-intensified active surveillance protocol, which would improve both the tolerability and cost-effectiveness of this management strategy.

scholarly journals The prevalence and locations of bone metastases using whole-body MRI in treatment-naïve intermediate- and high-risk prostate cancer

2020 ◽  
Author(s):  
Fredrik Ottosson ◽  
Eduard Baco ◽  
Peter M. Lauritzen ◽  
Erik Rud
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Bone Metastases ◽  
Whole Body ◽  
Gleason Grade ◽  
Grade Group ◽  
Whole Body Mri ◽  
High Risk Prostate Cancer ◽  
Treatment Naïve ◽  
Group 3

Abstract Objective The aim of this study was to assess the prevalence and distribution of bone metastases in treatment-naïve prostate cancer patients eligible for a metastatic workup using whole-body MRI, and to evaluate the results in light of current guidelines. Methods This single-institution, retrospective study included all patients with treatment-naïve prostate cancer referred to whole-body MRI during 2016 and 2017. All were eligible for a metastatic workup according to the guidelines: PSA > 20 ng/ml and/or Gleason grade group ≥ 3 and/or cT ≥ 2c and/or bone symptoms. The definition of a metastasis was descriptive and based on the original MRI reports. The anatomical location of metastases was registered. Results We included 161 patients with newly diagnosed prostate cancer of which 36 (22%) were intermediate-risk and 125 (78%) were high-risk. The median age and PSA were 71 years (IQR 64–76) and 13 ng/ml (IQR 8–28), respectively. Bone metastases were found in 12 patients (7%, 95% CI: 4–13), and all were high-risk with Gleason grade group ≥ 4. The pelvis was affected in 4 patients, and the spine + pelvis in the remaining 8. No patients demonstrated metastases to the spine without concomitant metastases in the pelvis. Limitations are the small number of metastases and retrospective design. Conclusion This study suggests that the overall prevalence of bone metastases using the current guidelines for screening is quite low. No metastases were seen in the case of Gleason grade group ≤ 3, and further studies should investigate if it necessary to screen non-high-risk patients. Key Points • The overall prevalence of bone metastases was 7% in the case of newly diagnosed intermediate- and high-risk prostate cancer. • The prevalence in high-risk patients was 10%, and no metastases were seen in patients with Gleason grade group ≤ 3. • The pelvic skeleton is the main site, and no metastases occurred in the spine without concomitant pelvic metastases.

Considerations for active surveillance in select Gleason grade group 2 patients: A preliminary study.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 206-206
Author(s):  
Jillian Egan ◽  
Cheyenne Williams ◽  
Nabila Khondakar ◽  
Luke P. O'Connor ◽  
Michael Daneshvar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Oncologic Outcomes ◽  
Definitive Treatment ◽  
Rank Test ◽  
P Value ◽  
Gleason Grade ◽  
Intermediate Risk ◽  
Grade Group ◽  
Definitive Therapy

206 Background: While active surveillance (AS) has become the preferred management strategy for patients with NCCN very-low and low risk prostate cancer, its use in the setting of intermediate risk disease continues to be controversial. Current guidelines state that AS can be considered in favorable intermediate risk disease, but data on outcomes in this cohort of patients is lacking. We aim to report on our experience with AS of Gleason grade group (GG) 2 at the National Cancer Institute (NCI)/National Institutes of Health (NIH). Methods: Our IRB-approved, institutional database was reviewed for men who enrolled on our AS protocol at NIH with GG2 disease from 2007-2020. All patients received MRI-targeted and systematic biopsy at the time of enrollment, diagnosing or confirming GG2 disease. MRI and PSA were performed annually, and majority of patients underwent annual combined MRI targeted and systematic prostate biopsy. If PSA and MRI were stable, annual biopsy was postponed in several patients based on their preference. Differences in PSA and PSAD at enrollment on AS and at progression were compared using Wilcoxon signed rank test. P value < 0.05 was considered significant. Results: 98 patients with GG2 disease enrolled in AS at NIH. Average age at enrollment was 64 years old and the majority of patients were Caucasian. 36/98(37%) of these patients progressed to GG3 or higher while on AS. Median PSA at time of progression was significantly higher than at the time of enrollment on AS (5.2 [IQR 4.0-8.9] vs 8.5 [IQR 5.8-10.9], z = -3.12, p < 0.01). PSAD was also significantly higher at time of progression (0.12[IQR 0.1-0.16] vs 0.13[IQR 0.10-0.22], z = -2.65, p < 0.01). Highest PIRADS score on MRI was largely unchanged. Median time to progression was 71 months. The majority of patients progressed to GG3, and progression was the trigger for definitive treatment. All patients were alive at the end of the follow up period. Conclusions: AS is a reasonable option for compliant patients diagnosed with GG2 prostate cancer. While a significant percentage of these men will progress on AS, they do so at a median of 71 months, avoiding treatment-related harms of definitive therapy for over 5 years. Further research with larger sample sizes are needed to better evaluate the oncologic outcomes of AS for GG2 disease, as well as predictors of more aggressive disease that may be better served with upfront definitive treatment. [Table: see text]

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