Initial results of patients with early-stage prostate cancer on active holistic surveillance.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 19-19
Author(s):  
Aaron Katz ◽  
Andrew S Fontes ◽  
Kaitlin E. Kosinski

19 Background: There is currently no consensus on how active surveillance should be utilized in order to optimize the benefit of patients with prostate cancer (PCa) to prevent overtreatment. Our institution’s protocol, known as Active Holistic Surveillance (AHS) integrates MRI screening in the place of serial biopsies. Nutritional supplements and lifestyle changes are also suggested in order to provide a holistic way to reduce progression. We look to compare definitive treatment rates of our cohort on AHS to other publications in the literature. Methods: A retrospective chart review was conducted on 200 patients placed on active surveillance for low and low-intermediate risk PCa under D’Amico criteria from February 2002 to July 2015. Enrollment criteria was defined by clinical stage (T1c), PSA under 20 ng/mL, diagnosis of a Gleason 6 or Gleason 7 with a tumor volume of >50%, and a PSA doubling time of greater than 1 year. The main objective of the study was to evaluate the rate of patients discontinuing AHS to receive definitive therapy and reasons for leaving our AHS protocol. Results: 200 patients (age 44-84 years) have a median follow-up of 40 months (range 4-161). A total of 24 out of 200 patients (12%) moved on to definitive treatment. For patients on AHS before 2010 until 2012, the rates of definitive treatment were 0%. In 2013, 8 patients (4%) received definitive treatment. In 2014, 12 patients (6%) received definitive treatment. In 2015, 4 patients (2%) received definitive treatment to date.The average treatment rate per year is 4%. Reasons for 24 patients discontinuing AHS included biopsy progression (16.67%), MRI progression (29.17%), MRI progression with biopsy confirmation (29.17%), patient preference (20.83%), and 1 patient was deceased due to an unrelated illness (4.17%). Conclusions: Low rates of discontinuation compared to other publications in the literature demonstrate that AHS can be a successful protocol for low-risk and low-intermediate risk PCa patients, and that a holistic approach can be beneficial to active surveillance patients.

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Rashid K. Sayyid ◽  
Laurence Klotz ◽  
John Z. Benton ◽  
Merry Ma ◽  
Phillip Woodruff ◽  
...  

Introduction: Active surveillance (AS) is increasingly used for favorable intermediate-risk (FIR) prostate cancer (PCa). Our objective was to determine oncological and sociodemographic predictors of deferred definitive therapy and decision for radical prostatectomy (RP) vs. radiotherapy (XRT). Methods: The Surveillance, Epidemiology, and End Results Prostate with Watchful Waiting database was used to identify all FIR PCa diagnosed between 2010 and 2015 opting for AS for at least one year following diagnosis. We sought to determine predictors of treatment and treatment type using multivariable logistic regression. Results: A total of 20 334 patients were identified. An annual decrease in incident FIR patients managed initially with AS between 2010 (4061) and 2015 (2947) was noted (p for trend <0.001); 17 895 (88.0%) patients underwent deferred RP and/or XRT. Patients with higher baseline cancer volume and clinical stage were significantly more likely to discontinue AS. Patients of higher socioeconomic status were more likely to undergo deferred therapy, with increased odds for XRT over RP. African American patients had lower odds of undergoing definitive intervention (odds ratio 0.83, p=0.030) and were significantly more likely to opt for XRT. Oncological characteristics leading to FIR classification influenced treatment choice at the time of deferred intervention: XRT was treatment of choice in 86.3% and 86.0% of Gleason group 2 and PSA 10–20 FIR patients, respectively; 96.1% of treated cT2b-c FIR patients opted for RP. Conclusions: Most FIR PCa patients initially managed with AS eventually undergo deferred definitive therapy, with choice of treatment significantly influenced by patients’ baseline oncological and sociodemographic characteristics.


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 206-206
Author(s):  
Jillian Egan ◽  
Cheyenne Williams ◽  
Nabila Khondakar ◽  
Luke P. O'Connor ◽  
Michael Daneshvar ◽  
...  

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]


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 104-104
Author(s):  
V. Jethava ◽  
D. Vesprini ◽  
D. A. Loblaw ◽  
A. Mamedov ◽  
R. Nam ◽  
...  

104 Background: Prostate cancer is the most prevalent non-cutaneous cancer among North American men. Approximately 50% of these are favorable risk cancers; the NCCN guideline recommends active surveillance for these patients. Patients are generally followed by serial PSAs, DREs and/or TRUS-guided biopsies with triggers identified for each test. Consequently, about 30% of these cancers will be reclassified to a higher risk and require definitive treatment. Cases treated with radical prostatectomy (rP) give important insights into the biology of these cancers. Methods: The ASURE database of active surveillance patients was used to identify cases; a retrospective chart review was completed. The following variables were extracted: primary reason for rP; % biochemical failure; % of patients requiring salvage radiation or hormone therapy; Gleason score (GS), tumor size staging and nodal status in the rP specimen; cause and rate of mortality; proportion of patients treated for PSA-doubling times less then 3 years presenting with a GS greater than 7. Descriptive statistics were used to summarize the results. Results: Of 566 patients in the ASURE database, the charts of 26 patients having an rP were extracted. The primary cause for an rP was a PSA-doubling times less than 3 years (57% of patients) followed by a biopsy indicating a GS of 4+3 or greater (19%). 7% of patients (2/26) were not reclassified but preferred to be treated with rP. 4 patients had biochemical failure (15%) all 4 had salvage therapy. There was 1 cause-specific death. 85% of rP specimens had GS 7, while the remaining had GS 6. Half of these GS 7 individuals had PSA doubling times of less than 3 years. Conclusions: Radical prostatectomy appears to be an effective deferred treatment for patients who are reclassified on active surveillance as evidenced by low prostate-cancer mortality, low rates of biochemical failure acceptable use of salvage therapy. Of interest is that the majority patients with PSAdt < 3 y have Gleason 7 disease on specimen. No significant financial relationships to disclose.


2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 238-238
Author(s):  
David D. Buethe ◽  
Christopher Russell ◽  
Binglin Yue ◽  
Hui-Yi Lin ◽  
Julio M. Pow-Sang

238 Background: Limited derived benefit from definitive treatment has been observed with respect to prostate cancer−specific mortality (PCSM) in those low−risk disease and only small absolute risk reductions in both overall PCSM and incidence of metastasis have been demonstrated. Thus, active surveillance (AS) strategies have been adopted to monitor for disease progression with intent for intervention at time of disease reclassification. Yet, the timing and frequency of surveillance remain without evidence-based standardization. We assessed the relationship between the frequency of surveillance prostate biopsies and the oncologic outcomes in those patients with low−risk prostate cancer (CaP) managed by AS. Methods: An IRB approved retrospective chart review identified 114 patients placed on AS for their CaP between November of 1997 and November of 2000. Of those, 96 patients meet study inclusion criteria mandating a Gleason sum of < 7, tumor presence in < 4 sextets, involvement of <50% of any single biopsy core. Eligible patients were surveyed by serum PSA, DRE, and surveillance TRUS−guided biopsies at physician determined intervals. Results: At diagnosis, the mean age was 70.3 (SD±5.3) years with a mean PSA value of 8.2 (SD±8.2) ng/dL. While on AS, patients underwent a median of 3.5 (SD±2.02) TRUS−guided biopsies; at a frequency approaching 1 biopsy every 18 months. At a median follow−up of 134.8 months (95%CI: 114.5, 148.7), multivariate analysis found more frequent prostatic biopsy acquisition to be inversely associated a worse prognosis with respect to both progression−free (p<0.0001) and overall survival (p=0.0002). Both progression−free (p<0.0001) and overall survival (p=0.0207) were progressively shorter as the interval between biopsies declined from greater than 2 years, to 1−2 years, and then less than 1 year. Conclusions: No survival advantage was achieved by frequent re−biopsy of the prostate. Patients biopsied more frequently were paradoxically found have poorer survival outcomes.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 124-124
Author(s):  
Michael S. Leapman ◽  
Janet E. Cowan ◽  
Hao Gia Nguyen ◽  
Matthew R. Cooperberg ◽  
Peter Carroll

124 Background: A biopsy-based RT-PCR assay (Oncotype DX Prostate Assay) providing a Genomic Prostate Score (GPS) as a measure of tumor aggressiveness has been validated as a predictor of adverse pathologic and oncologic outcomes. We sought to evaluate the change in GPS results among men with favorable-risk prostate cancer (PCa) managed with active surveillance (AS). Methods: We identified men with low and intermediate-clinical risk PCa managed with AS at our institution receiving a minimum of two GPS tests on serial prostate biopsy. GPS ranges from 0 (least) to 100 (most aggressive disease). We described the change in assay results and clinical risk designation over time and reported the subsequent clinical outcome (definitive treatment versus continued AS). For men receiving treatment with radical prostatectomy (RP) the occurrence of adverse pathological findings was defined by the presence of high grade (Gleason pattern ≥ 4+3) or non-organ confined disease ( ≥ pT3a). Results: 31 men were identified who underwent serial GPS testing at a median of 12 months. The median change in GPS was an increase of 1 point (IQR -7, 13). Fourteen (45%) patients experienced an increase in NCCN risk classification, including 3 from very-low to intermediate and 11 from low to intermediate risk. Following serial GPS testing 7 patients (23%) underwent radical prostatectomy. Among surgically treated patients, 3 had adverse pathology due to pT3a disease and the mean change in GPS prior to treatment was an increase of 13 points (IQR -7, 18); all of whom were intermediate clinical risk at the time of surgery. This study was limited by the small sample size and the uncontrolled decision to pursue definitive therapy. Conclusions: Serial change in a tissue based gene expression assay on serial biopsy during AS was non-static. Magnitude of GPS change may identify men at risk for adverse pathological findings, although larger series are required to validate such an endpoint during AS.


2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 105-105
Author(s):  
Diederik Meindert Somford ◽  
Caroline M. Hoeks ◽  
Roderick C. van den Bergh ◽  
Henk Vergunst ◽  
Inge M van Oort ◽  
...  

105 Background: To prevent overtreatment of insignificant and/or low-risk prostate carcinoma in the PSA screening era, active surveillance is emerging as a treatment strategy for selected patients. In our series we aim to establish whether MRI could aid in correct risk assessment for these patients within the framework of the Prostate Cancer Research International Active Surveillance (PRIAS) study. Methods: We included patients in our protocol based on contemporary criteria for active surveillance: - Diagnosis of prostate cancer by TRUS-guided biopsy. - PSA ≤10 ng/mL, PSA density <0.2 ng/mL/mL - Clinical stage ≤ T2 - Gleason score (GS) ≤3+3=6 - ≤ 2 biopsy cores with cancer All patients underwent multimodality MRI of the prostate, including T2-weighted, diffusion-weighted and dynamic contrast-enhanced MR sequences. When a tumor-suspicious region (TSR) could be identified a targeted MR-guided biopsy (MRGB) was performed to obtain pathology. Patients were referred for definitive treatment in case of GS > 3+3=6 upon MRGB or T3 stage at MRI. Results: In 48 of 49 included patients at least one TSR was identified, with a median of 2 TSRs (range1-4) per patient. MRGB was obtained from every TSR, with a median of 4 MRGBs taken per patient. Five patients had a GS >3+3=6 upon MRGB and were excluded. Three patients were excluded due to suspicion of T3 stage on MRI. Five patient were excluded upon physician’s discretion due to multifocal prostate cancer upon MRGB. Combined multimodality MRI/MRGB in our active surveillance cohort thus excluded 27% (13/49) of patients who were incorrectly stratified as low-risk prostate carcinoma by contemporary criteria. Conclusions: Application of multimodality MRI and MRGB in an active surveillance protocol improves risk stratification, adding onto contemporary PSA and TRUS-guided biopsy criteria for low-risk prostate cancer. This approach might increase safety and reliability of active surveillance for prostate cancer and deserves ongoing prospective evaluation.


2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 136-136 ◽  
Author(s):  
Erika L. Wood ◽  
Steven Canfield

136 Background: The standard of care for managing localized prostate cancer includes offering patients active surveillance. With the 10-year prostate cancer specific survival between 96-100% for both low and low-intermediate risk patients, active surveillance has proven to be a safe and effective option. Most studies have examined cohorts of patients within a tertiary referral center but data is sparse on county hospital patients, where health insurance coverage among other concerns pose barriers for patients to receive consistent medical care. We were interested in how active surveillance was performing amongst a cohort of county hospital based patients. Methods: A retrospective chart review was conducted on fifty patients placed on active surveillance for low and low-intermediate risk prostate cancer (by D’Amico criteria) between July 1, 2007 and August 1, 2013. Overall and cause-specific survival were the main outcome measures. Data was also collected on loss to follow-up rates. Results: In the cohort, the mean age at diagnosis was 62.2, mean body mass index was 28.0, most were African American or Hispanic (50% and 46%, respectively) and the majority had low-risk disease (84%). The median length of follow-up after diagnosis was 22 months. Nearly half of patients stopped active surveillance (44%), the most common reason being reclassification of their disease after second biopsy. All patients who were reclassified received definitive treatment with the exception of one patient who was lost to follow-up. Cause-specific and overall mortality were both 100% in this cohort. Nearly a quarter of patients (22%) were lost to follow-up (either had less than 12 months of surveillance following diagnosis or had not presented to clinic within the last 12 months). Conclusions: High rates of loss to follow-up present a significant challenge to managing localized prostate cancer with active surveillance in a county hospital population. In this small cohort, active surveillance appears to be a safe and effective management option for localized prostate cancer, yet undetected disease progression remains a significant concern.


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 20-20
Author(s):  
Takuma Kato ◽  
Mikio Sugimoto ◽  
Yoshiyuki Kakehi ◽  
Akito Yamaguchi ◽  
Akira Yokomizo ◽  
...  

20 Background: We assessed the outcomes of the patients with pT0 on first protocol biopsy during active surveillance(AS) from the analysis Japanese cohort forming part of the Prostate Cancer Research International: Active Surveillance (PRIAS) study. Methods: PRIAS-JAPAN started in January 2010. 39 institutions are participating in this study. The inclusion criteria for the PRIAS study are as follows: clinical stage T1c/T2, PSA ≤ 10 ng/ml, PSA density (PSAD) < 0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) ≤ 6 at initial diagnostic biopsy.In this analysis, we defined the patients presenting no reclassification with cancer after first protocol biopsy as NR-CA group and the patients presenting no reclassification showing pT0 as NR-noCA group. We compared AS remaining rate, pathological outcomes in extra biopsy and second protocol biopsy at 4 years between two groups. Results: First protocol biopsy was performed on 514 patients. 191 patients were in NR-noCA group and 199 patients were in NR-CA group. Patients background of NR-noCA group was as follows: Median age was 68, median PSA was 5.6ng/ml, and median prostate volume was 38.4cc. T1c were in 183 and T2a were in 8. At the time of first protocol biopsy, there was no significant differences about PSA parameters and pathological factors between NR-noCA group and NR-CA group. Also, extra biopsy performing rate (NR-noCA group vs NR-CA group; 5.75% vs 7.53%) and implementation rate of second protocol biopsy at 4 years (75.6% vs 63.6%) showed no significant differences. On second protocol biopsy, number of cancer positive cores were significantly smaller and rate of pT0 was higher in NR-noCA group. After five years, both group showed comparable AS remaining rate (76.9 vs 75.3%). Thirty eight patients of NR-noCA group selected definitive therapy and surgery was the most frequently chosen treatment option. Conclusions: Although rate of pT0 on second biopsy was higher in NR-noCA group, there was no significant difference between both groups in AS remaining rate. The patients in NR-noCA group tended to choose surgery as a definitive therapy. Clinical trial information: UMIN000002874.


2012 ◽  
Vol 30 (30_suppl) ◽  
pp. 37-37
Author(s):  
Nicholas Erho ◽  
Ismael A. Vergara ◽  
Christine Buerki ◽  
Mercedeh Ghadessi ◽  
Anamaria Crisan ◽  
...  

37 Background: More than 90% of patients diagnosed with organ-confined prostate cancer (PCa) choose upfront definitive treatment (e.g., radical surgery) even though many are excellent candidates for delayed therapy (i.e., active surveillance [AS]). Therefore, patients may suffer from the adverse effects of treatment without gaining any benefit. Biomarker signatures that predict tumour aggressiveness are promising tools for identification of patients suited for AS. In this study, we use a transcriptome-wide assay to develop a biomarker signature for patients assessed as low risk at diagnosis who are upgraded or upstaged following radical prostatectomy (RP). Methods: Gene expression data of 56 RP samples from the Memorial Sloan Kettering Oncogenome Project (GSE21034) which met the low risk criteria (i.e., biopsy Gleason score (GS) ≤ 6, clinical stage T1 or T2A, and pre-operative PSA (pre-op PSA) ≤ 10 ng/ml) were used to develop the signature. Of these tumors, 31 underwent upgrading or upstaging (defined by pathological GS ≥ 7 or a pathological tumor stage > T3A). In the training set (n = 29) a median fold difference filter (MFD > 1.4) was applied to select features. The top 16 t-test ranked features were modelled with a K-nearest-neighbor (KNN) classifier (k = 3) which predicts upgrading/upstaging events. Results: The KNN was applied to the test set (n = 27) and achieved an area under the receiver operating characteristic curve (AUC) of 0.93, significantly better discrimination than pre-op PSA (AUC = 0.52) or tumor stage (AUC = 0.63). Compared to the null model’s accuracy of 56%, the KNN correctly predicts 81% (p-value < 0.005) of the upgrading/upstaging events. In multivariable analysis with pre-op PSA, tumor stage, and age at diagnosis, the KNN remained the only significant (p < 0.05) factor with an odds ratio of 2.7. Conclusions: A 16 marker signature was identified from RP specimens and shown to accurately segregate true low risk patients from those which transitioned to higher risk. Validation studies of this signature in prospectively designed cohorts of active surveillance candidates are underway to determine if the molecular signature can improve treatment and management decisions for low risk PCa patients.


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