Managing low risk prostate cancer: A cost analysis.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 50-50
Author(s):  
Franklin Gaylis ◽  
Kevin McGill ◽  
Susan S Levy ◽  
Catherine E Ball ◽  
Hillary Prime ◽  
...  

50 Background: Healthcare costs in the US continue to rise at an unsustainable rate. Prostate cancer (PCa) accounts for 21% of all new cancer cases in men and is predicted to incur a cost of $18.53 billion in the next few years. In this study we examined the costs associated with managing low-risk PCa with traditional treatment options compared to Active Surveillance. Methods: One hundred ninety-five patients were identified as NCCN defined low-risk PCa (Gleason score ≤ 6, PSA < 10, clinical stage T1c to T2a) between January 1, 2012 to June 30, 2013 at Genesis Healthcare Partners (GHP). Ninety three (48.7%) patients had at least 3 years of follow-up care and formed the cohort for analysis. Treatment paths analyzed included active surveillance (AS), radical prostatectomy (RP), stereotactic body radiation therapy (SBRT) and intensity-modulated radiation therapy/image-guided radiation therapy (IMRT/IGRT). Patients’ charts were examined for all episodes of care during the three-year period subsequent to their first positive biopsy and cost attribution to each episode was based on a cost-to-Medicare perspective using the Medicare Physician Fee Schedule (MPFS) for GHP. Total and annual costs of care were compared for patients followed for a 3-year period using one-way analysis of covariance (ANCOVA), covarying for patient age and Charlson Comorbidity Index (CCI). Results: Active surveillance ($4,072 ± $1354) compared to RP ($9,972 ± $1571), SBRT ($26,294 ± $2049), and IMRT/IGRT ($40,438 ± $2091) had significantly lower total 3-year costs ( p < .001, ɳ² = .44) compared to those in the other treatments group. Specific characteristics of the AS cohort’s treatment path included an average number of biopsies of 2.0 ± 0.8 and only six (21%) patients had at least one MRI performed during their treatment path. Active surveillance with a more costly genomic study (n = 4) incurred a cost of $9,475 ± $1456 over three years. Conclusions: Active surveillance may be considered a beneficial management strategy for low-risk PCa from a cost perspective. The cost effective benefit as well as the avoidance of treatment (surgery, radiation therapy) related side effects, support its consideration as a value-based care model, the primary goal of the Medicare Access and Chip Reauthorization Act.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 82-82
Author(s):  
Fred Saad ◽  
Margaret Fitch ◽  
Kittie Pang ◽  
Veronique Ouellet ◽  
Carmen Loiselle ◽  
...  

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.


2019 ◽  
Vol 10 (3) ◽  
pp. 37-44
Author(s):  
M. S. Taratkin ◽  
E. A. Laukhtina ◽  
K. I. Adelman ◽  
Y. G. Alyaev ◽  
L. M. Rapoport ◽  
...  

Prostate cancer (PCa) is the most common oncological disease among men. It is important to note that over 50% of the first identified primary malignant neoplasms of prostate are low - risk PCa. Recently, radical prostatectomy and external beam radiation therapy have been the standard treatment options for PCa. According to recent data, patients with low - risk PCa have a favourable prognosis because of the slow progression of the disease. Some studies show no links between 10-year cancer - specific survival and treatment modalities and no progression even in the absence of therapy. Active surveillance (AS) allows avoiding unnecessary treatment in men who do not require immediate intervention but achieves the correct timing for curative treatment in those who eventually need it. According to the guidelines of the European Association of Urology, AS is one of the standard treatment options for low - risk PCa and should be consideredfor all patients in this category. The advantage of AS is to improve the quality of life in men with low - risk PCa and to delay surgical interventions as much as possible. However, despite widespread AS worldwide, there are only a few centres, which use it routinely in Russia. In this review, we would like to shed some light on the most important questions of AS strategy: what criteria should we use for selection of patients for AS strategy? How often should patient visit the urologist, control PSA level, and undergo prostate biopsy? When should a doctor change strategy and turn to active treatment? In this article, we considered indications for AS in men with PCa and showed the most recent data on the efficacy and relevance of this modality.


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. 178-178
Author(s):  
Hima Bindu Musunuru ◽  
Gerard Morton ◽  
Laurence Klotz ◽  
Danny Vespirini ◽  
Patrick Cheung ◽  
...  

178 Background: To evaluate outcomes and treatment history of low risk (LR) prostate cancer patients(pts) diagnosed between 2006-2008 in a single academic institute. Methods: Treatment and toxicity details were retrieved through retrospective chart review,apart from surgery where toxicity data was not available in detail.Biochemical RFS following primary and salvage treatments and CSS were computed.Pts who underwent salvage treatment for local failure and subsequently remained under biochemical control were censored as disease free for the salvage bRFS. Results: 594 pts were eligible for this study. Treatment options were active surveillance (AS=178 pts), low dose rate brachytherapy (LDR=192 pts, I-125 implant), stereotactic ablative body radiotherapy (SABR =84 pts; 35Gy in 5 weekly fractions), external beam radiation (EBRT=81 pts; 76Gy ) and radical prostatectomy (RP=59 pts). Median follow was > 70 months in all cohorts. 17.9% on AS protocol underwent active treatment. Biochemical failures were detected in 9 (5%), 10 (5.2%), 3 (3.5%), 6 (7.4%) and 9 (15.3%) pts respectively. Out of these, 4 pts in AS cohort, 2 in SABR group, and 7 in RP underwent local/salvage treatment. The 7-year bRFS was 94.4%, 93.6%, 95.8%, 90.1% and 89.5% for primary treatment and 95.7%, 93.6%, 98.7%, 90.1% and 98.3% following salvage treatment. 1 pt in AS, 2 in LDR, 1 pt in SABR and EBRT group developed metastatic disease. The 6 year CSS was 100% in all groups apart from LDR (99.4%) and EBRT (98.8%). Significant dysuria (20.8%) and hematochezia (7.4%) were noticed in EBRT cohort (Table). One grade 4 toxicity was noted in LDR, SABR and EBRT pts. Conclusions: AS has CSS comparable to other treatment options in LR prostate cancer setting with minimal toxicity. In the primary setting all treatment modalities apart from RP and EBRT have 7-year bRFS >93%. Differences in bRFS following salvage treatment might be due to pt and treatment selection. [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16572-e16572
Author(s):  
Alexa Meyer ◽  
Nancy Stambler ◽  
Karl Sjöstrand ◽  
Jens Richter ◽  
Mohamad Allaf ◽  
...  

e16572 Background: Previous work has shown that the degree of expression of prostate-specific membrane antigen (PSMA) correlates with prostate cancer (PCa) grade and stage. We evaluated the additive value of a deep learning algorithm (PSMA-AI) of a PSMA-targeted small molecule SPECT/CT imaging agent (99mTc-MIP-1404) to identify men with low risk PCa who are potential active surveillance candidates. Methods: A secondary analysis of a phase III trial (NCT02615067) of men with PCa who underwent 99mTc-MIP-1404 SPECT/CT was conducted. Patients with a biopsy Gleason score (GS) of ≤6, clinical stage ≤T2, and prostate specific antigen (PSA) < 10 ng/mL who underwent radical prostatectomy (RP) following SPECT/CT were included in the present analysis. SPECT/CT images were retrospectively analyzed by PSMA-AI, which was developed and locked prior to analysis. PSMA-AI calculated the uptake of 99mTc-MIP-1404 against the background reference (TBR). The automated TBR of 14 was used as a threshold for PSMA-AI calls of positive disease. Multivariable logistic regression analysis was used to develop a base model for identifying men with occult GS ≥7 PCa in the RP specimen. This model included PSA density, % positive biopsy cores, and clinical stage. The diagnostic performance of this model was then compared to a second model that incorporated PSMA-AI calls. Results: In total, 87 patients enrolled in the original trial contributed to the analysis. The base model indicated that PSA density and % positive cores were significantly associated with occult GS ≥7 PCa (p < 0.05), but clinical stage was not (p = 0.23). The predictive ability of the model resulted in an area under the curve (AUC) of 0.73. Upon adding PSMA-AI calls, the AUC increased to 0.77. PSMA-AI calls (p = 0.045), pre-surgery PSA density (0.019) and % positive core (p < 0.004) remained statistically significant. PSMA-AI calls increased the positive predictive value from 70% to 77% and the negative predictive value from 57% to 74%. Conclusions: The addition of PSMA-AI calls demonstrated a significant improvement over known predictors for identifying men with occult GS ≥7 PCa, who are inappropriate candidates for active surveillance. Clinical trial information: NCT02615067.


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.


2019 ◽  
Vol 39 (8) ◽  
pp. 962-974
Author(s):  
Richard M. Hoffman ◽  
Tania Lobo ◽  
Stephen K. Van Den Eeden ◽  
Kimberly M. Davis ◽  
George Luta ◽  
...  

Background. Men with a low-risk prostate cancer (PCa) should consider observation, particularly active surveillance (AS), a monitoring strategy that avoids active treatment (AT) in the absence of disease progression. Objective. To determine clinical and decision-making factors predicting treatment selection. Design. Prospective cohort study. Setting. Kaiser Permanente Northern California (KPNC). Patients. Men newly diagnosed with low-risk PCa between 2012 and 2014 who remained enrolled in KPNC for 12 months following diagnosis. Measurements. We used surveys and medical record abstractions to measure sociodemographic and clinical characteristics and psychological and decision-making factors. Men were classified as being on observation if they did not undergo AT within 12 months of diagnosis. We performed multivariable logistic regression analyses. Results. The average age of the 1171 subjects was 61.5 years ( s = 7.2 years), and 81% were white. Overall, 639 (57%) were managed with observation; in adjusted analyses, significant predictors of observation included awareness of low-risk status (odds ratio 1.75; 95% confidence interval 1.04–2.94), knowing that observation was an option (3.62; 1.62–8.09), having concerns about treatment-related quality of life (1.21, 1.09–1.34), reporting a urologist recommendation for observation (8.20; 4.68–14.4), and having a lower clinical stage (T1c v. T2a, 2.11; 1.16–3.84). Conversely, valuing cancer control (1.54; 1.37–1.72) and greater decisional certainty (1.66; 1.18–2.35) were predictive of AT. Limitations. Results may be less generalizable to other types of health care systems and to more diverse populations. Conclusions. Many participants selected observation, and this was associated with tumor characteristics. However, nonclinical decisional factors also independently predicted treatment selection. Efforts to provide early decision support, particularly targeting knowledge deficits, and reassurance to men with low-risk cancers may facilitate better decision making and increase uptake of observation, particularly AS.


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