The fluciclovine (FACBC) PET/CT site-directed therapy of oligometastatic prostate cancer (Flu-BLAST-PC) trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5099-TPS5099
Author(s):  
Risa Liang Wong ◽  
Sarah K Holt ◽  
Jing Zeng ◽  
Laura Graham ◽  
Rachel Kang ◽  
...  

TPS5099 Background: Patients with biochemical recurrence (BCR) after local definitive therapy for prostate cancer (PC) represent the largest group of patients alive with PC in the United States. For patients with BCR after both radical prostatectomy and radiation, no further definitive treatment options currently exist as standard of care. FACBC PET/CT is a next-generation imaging modality approved in 2016 for suspected PC recurrence based on elevated PSA levels following prior treatment. FACBC PET/CT allows for earlier detection at lower PSA levels of oligometastatic PC in patients who would otherwise be considered as having micro-metastatic disease. FACBC PET/CT may provide potential targets for site-directed therapy; however, it is unknown whether this approach leads to improvement in clinically relevant outcomes. Methods: Flu-BLAST-PC (ClinicalTrials.gov Identifier: NCT0417543) is a prospective, interventional study enrolling men with PC and BCR who have previously undergone both radical prostatectomy and adjuvant or salvage radiation to the prostatic fossa, with PSA ≥0.5 to < 10 ng/mL, PSA doubling time > 3 to < 18 months, and no radiographically detectable metastases by conventional CT and bone scan imaging. Enrolled patients undergo FACBC PET/CT imaging, and those with no PC metastases detected (Group 1) undergo observation with repeat FACBC PET/CT performed at PSA thresholds of > 2 and > 5 ng/mL, with eligibility for the trial ending at PSA ≥10 ng/mL if FACBC PET/CT remains negative. Those with 1-3 PC regions (defined as radiation fields) detected on FACBC PET/CT (Group 2) undergo site-directed therapy with surgery (e.g. lymphadenectomy) and/or radiation, as well as six months of systemic treatment with androgen deprivation therapy (ADT) and abiraterone acetate with prednisone. Patients with ≥4 PC regions detected on FACBC PET/CT (Group 3) undergo six months of ADT and abiraterone acetate with prednisone without any site-directed therapy. Patients initially in Group 1 who subsequently have PC metastases detected on repeat FACBC PET/CT imaging per protocol join Group 2 or Group 3 based on the number of PC regions involved. Given the long anticipated survival of patients with PC and BCR, the primary endpoint of the study is undetectable PSA ( < 0.2 ng/mL) rate in Group 2 at two years beyond study treatment, with secondary endpoints including the same outcome measure for Group 3, undetectable PSA rate two years after testosterone recovery from ADT in Groups 2 and 3, time to re-initiation of ADT, overall survival, and safety and tolerability. Assuming a null hypothesis of 15% undetectable PSA rate for patients with BCR two years after completing ADT and alternative hypothesis of improvement to 40% in Group 2, planned enrollment is 65 patients in Group 2. This will provide 90% power at the two-sided significance level of 0.05. Five patients have enrolled to date. Clinical trial information: NCT0417543.

2020 ◽  
Author(s):  
SEVASTIAN MEDINA-ORNELAS ◽  
FRANCISCO OSVALDO GARCIA-PEREZ ◽  
MIGUEL Alvarez-Avitia ◽  
NORA SOBREVILLA-MORENO ◽  
ZAEL SANTANA-RIOS ◽  
...  

Abstract Objective: Evaluate impact after 223 Ra therapy and 18 F-NaF (sodium fluoride) PET/CT in the selection and evaluation of response in patients treated with 223 Ra in six different solid tumors. Material and Methods: Twenty patients with metastatic castration-resistant prostate cancer (mCRPC), seven metastatic castration-sensitive prostate cancer (mCSPC), three osteosarcoma, two breast cancer, two non-small cell lung cancer (NSCLC), one chondrosarcoma, one chordoma and one patient lung neuroendocrine carcinoma. Three groups of study were defined according total skeletal tumor-burden obtained by 18 F-NaF PET/CT, group 1 <1000cm 3 , group 2 1001–2999cm 3 and group 3 >3000cm 3 VOI´s. A semi-quantitative comparison was performed measuring the SUVmax values of VOIs values in all bone metastases in each patient previous to receive the first cycle of 223 Ra, after 3 and 6 cycles. Results: 30 patients non-progress disease was documented after 24±4 weeks. 8 patients progress disease was presented after three cycles of 223 Ra, two patients with osteosarcoma, four patients with mCRPC, one patient with chondrosarcoma and one patient with NSCLC. Group 1 patients showed better response rates compared to group 3 (p<0.05). Group 2 patients who showed improvement clinical and radiological, had prostate malignancies compared to those in the same group, but non-prostatic malignancies (p<0.05). No significant difference in group 2 patients compared to group 3 (p<0.67). Symptomatic skeletal-related event was observed in 7 patients. Conclusion: 18 F-NaF PET/CT allows to identify patients who show osteoblastic bone activity and discard or confirm progression in the interval PET/CT image, allowing change of treatment, reducing costs. High tumor-burden strongly suggests a poor response to treatment


2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Daniar K. Osmonov ◽  
Alexey V. Aksenov ◽  
Annkathrin Boller ◽  
Almut Kalz ◽  
Diana Heimann ◽  
...  

Background. Treatment of patients with a biochemical recurrence (BCR) of prostate cancer (PCa) is generally difficult and without valid treatment options. Since 2004 we have been developing therapeutic possibilities for these patients.Methods. We retrospectively analyzed a cohort of 41 patients with a BCR of PCa and a mean followup of40.3±20.8months. Group 1 (n=10): salvage radical prostatectomy (sRP) with SePLND (salvage extended pelvic lymph nodes dissection) (initial treatment: combined brachytherapy). Group 2 (n=22): SePLND (initial treatment: radical prostatectomy (RP)). Group 3 (n=9): SePLND (initial treatment: RP and adjuvant radiation therapy (RT)). We observed PSA, PSA-velocity, localization of LNs and LNs+, BCR-free period, and BR (biochemical response).Results. Group 1: 60% with BCR-freedom (mean 27.2 months). Group 2: 63.6% with BCR-freedom (mean 17.5 months). Group 3: 33.3% with BCR-freedom (mean 17.6 months). In total, BCR-freedom was observed in 23 of 41 patients (56.1%) after salvage surgery. 75.6% of all patients showed a BR. 765 LNs were removed and 14.8% of these were LN+.Conclusions. The BCR-free period and BR are comparable in all three groups. Sensibility to ADT can be reestablished and prolonged as a result of SePLND. Multicenter studies are needed for a reliable output.


2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 236-236
Author(s):  
Sameer G. Jhavar ◽  
Erin Bird ◽  
Gregory P. Swanson

236 Background: To assess outcomes after artificial urinary sphincter implantation in men who received prior pelvic radiation therapy. Methods: Between 1997 and 2012, 107 patients were identified from the Scott and White Hospital database who underwent artificial urinary sphincter implantation for urinary incontinence after prostate cancer treatment. Of these 17 were excluded for lack of follow-up data. Of the remaining 90 patients, 59 patients underwent prior surgery alone (group 1), 25 underwent prior surgery followed by pelvic radiation therapy (group 2); and 6 patients underwent prior radiation therapy alone. Results: Average ages at sphincter implantation were 69 yrs. (range 54 - 82), 73 yrs. (range 63 - 81), and 70 yrs. (range 60 - 80) respectively for groups 1, 2 and 3. Social continence rates were 80% (47/59) for group 1, 72% (18/25) for Group 2 and 50% (3/6) for group 3 at an average follow-up of 6 yrs. (range 0 - 17), 4 yrs. (range 1 - 12) and 3 yrs. (range 0 - 6) respectively. Average time between surgery and sphincter implantation was 5 yrs. (range 1-27) in group 1. Average time between radiation and sphincter implantation was 7 yrs. (range 1 - 18) and 6 yrs. (range 1 - 17) in Groups 2 and 3. Re-operation rates were 42% (25/59); 48% (12/25); and 50% (3/6) in groups 1, 2, and 3, respectively. In men who were incontinent at last follow-up, the average time between pelvic radiation and sphincter placement was relatively shorter as compared to those who were continent [5 yrs. (range 1 -11) vs. 7 yrs. (range 1 - 18) in Group 2; and 4 yrs. (range 1 -5) vs.10 yrs. (range 4 - 17) in group 3]. The rates of erosions were 10/59 (17%); 4/25 (16%); and 0/6 (0%) in groups 1, 2, and 3, respectively. The rates of infection were 5/59 (8%), 0/25 (0%), and 2/6 (33%) in groups 1, 2, and 3, respectively. Conclusions: Our experience with artificial urinary sphincter in men who underwent prior pelvic radiation therapy is comparable to that reported in the literature. Our results identify factors associated with worse continence after artificial urinary sphincter in men who underwent prior pelvic radiation therapy.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5071-5071
Author(s):  
Iris Yeong- Fung Sheng ◽  
Yu-Wei Chen ◽  
Moshe Chaim Ornstein ◽  
Timothy D. Gilligan ◽  
Brian I. Rini ◽  
...  

5071 Background: Prostate specific antigen (PSA) screening has been controversial, given unrefined screening guidelines leading to overdiagnosis and overtreatment of “indolent” PCa. In 2008, the USPSTF recommended against PSA screening for men aged ≥75 and in 2012 broadened this recommendation to include all men. The impact of these changes is unstudied. We hypothesize that these screening changes could delay the diagnosis of advanced PCa. Methods: The Surveillance, Epidemiology and End Results Program (SEER) was used to identify men (age 55-69) diagnosed with PCa between 2004-2015. PCa stage was categorized as nodal (N1M0) and metastatic (NxM1). Trend analysis was stratified based on year 2004-2008 (group 1), 2009-2012 (group 2), and 2012-2015 (group 3). Using group 2 as a reference, multivariable logistic regression was used to identify predictors for N1M0 and NxM1 in each group. Results: From 2004-2015, there were 603,323 eligible men diagnosed with PCa (group 1: 262,240 men, group 2: 210,045 men, group 3: 131,038 men). In group 1, 1.4% had N1M0 and 2.8% had NxM1. In group 2, 1.6% had N1M0 and 3.7% had NxM1. In group 3, 1.4% had N1M0, and 6.1% had NxM1. The adjusted odds ratio (AOR) of N1M0 was 0.78 (95%CI 0.74-0.82; p<0.0001) in group 1 and 1.71 (95%CI 1.63-1.80; p<0.0001) in group 3. Similar AOR trends were seen in NxM1 (group 1, 0.71; 95%CI 0.68-0.73, p< 0.0001 vs. group 3, 1.70; 95% CI 1.63-1.75, p<0.0001). (Table) Subset analysis of non-eligible patients (age >70 and <55) showed a similar stage migration. Conclusions: With each USPSTF recommendation, there have been significantly more diagnoses of advanced PCa; suggesting stage migration. The sequelae of having advanced PCa include more aggressive treatments, increased financial burden, and reduced quality of life. Future population studies are warranted to investigate whether the updated 2018 USPSTF recommendation now encapsulates the best target population.[Table: see text]


2018 ◽  
Vol 108 (3) ◽  
pp. 622-632 ◽  
Author(s):  
Elaine A Yu ◽  
Peter J Hu ◽  
Saurabh Mehta

ABSTRACT Background Insulin regulates fatty acids (FAs) in the blood; conversely, FAs may mediate insulin sensitivity and are potentially modifiable risk factors of the diabetogenic state. Objective The objective of our study was to examine the associations between plasma concentrations of FAs, fasting plasma glucose (FPG), and glycated hemoglobin (HbA1c) among individuals (n = 1433) in the NHANES (2003–2004). Design Plasma concentrations of 24 individual FAs were considered individually and in subgroups, per chemical structure. Study participants were categorized in diabetogenic groups: Group 1 (HbA1c ≥6.5% or FPG ≥126 mg/dL), Group 2 (HbA1c 5.7% to &lt;6.5% or FPG 100 to &lt;126 mg/dL), and Group 3 (HbA1c &lt;5.7% and FPG &lt;100 mg/dL). We assessed associations between diabetogenic groups and plasma FAs in multivariate multinomial regressions (with Group 3 as the reference). Results Overall, 7.0% of study participants were in Group 1; 33.3% were in Group 2. Plasma concentrations of several individual FAs, including even-chain saturated FAs (SFAs; myristic, palmitic, stearic acids) and monounsaturated FAs (MUFAs; cis-vaccenic, oleic acids), were respectively associated with greater odds of Groups 1 and 2 status, adjusting for covariates. Higher concentrations of SFA and MUFA subgroups (highest compared with lowest quartile) were associated with increased odds of Group 2 status [SFAs adjusted OR (aOR): 1.51 (95% CI: 1.05, 2.18); MUFAs aOR: 1.78 (95% CI: 1.11, 2.85)]. Higher eicosapentaenoic acid plasma concentration was associated with decreased odds of Group 1 status [quartile 4 aOR: 0.41 (95% CI: 0.17, 0.95)]. Conclusions Higher plasma concentrations of SFAs and MUFAs, primary de novo lipogenesis products, were associated with elevated FPG and HbA1c in a nationally representative study population in the United States. Additional studies are necessary to elucidate potential causal relationships between FAs (from endogenous production and dietary consumption) and diabetogenic indicators, as well as clinical implications for managing diabetes and prediabetes.


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 44-44
Author(s):  
Masashi Kato ◽  
Toyonori Tsuzuki ◽  
Ryo Ishida ◽  
Tohru Kimura ◽  
Osamu Kamihira ◽  
...  

44 Background: The current ISUP/WHO grade group system classified the Gleason grade into five groups. Although presence of tertiary Gleason pattern 5 (tG5) reported to be related with unfavorable tumor characteristic, only a few data is available about influences on the grade group system of tG5 so far. In this study, we evaluated the effect of tG5 on recurrence following radical prostatectomy in patients with prostate cancer. Methods: We retrospectively evaluated 1,020 patients with prostate cancer who underwent radical prostatectomy without neoadjuvant therapy at the hospitals that the authors were affiliated with between 2005 and 2013. After excluding the patients with missing data or slides, 1000 patients were enrolled in this study. All prostatectomy specimen slides were reviewed by a single genitourinary pathologist according to ISUP 2014. Recurrence following radical prostatectomy was defined according to European Association of Urology guidelines. The endpoint was defined as an increase in PSA level. Results: Patient median age was 67 years (range 49–77 years). The median serum PSA was 6.9 ng/mL (range 0.4–82 ng/mL). The median follow-up period was 69 months (range 0.7–134 months). All the patients showed Group1:163 cases (16.3%), Group2: 436 (43.6%), Group 2 with tG5: 54 (5.4%), Group 3:121 (12.1%), Group 3 with tG5: 89 (8.9%), Group 4: 39 (3.9%), and Group 5: 98 (9.8%). PSA progression-free survival was significantly different among the five groups (Group1-5) (p = 0.0001). As concerning tG5, it showed significant difference between Group 2 and Group 2 with tG5 by using log rank test (p < 0.0001). Similarly, there was significant difference between Group 3 and Group 3 with tG5 (p = 0.001). On the other hand, there was no difference between Group 2 with tG5 and Group 3 (p = 0.916), and in the same way, no difference between Group 3 with tG5 and Group 4 (p = 0.854). Conclusions: The Presence of tG5 on the grade group system increase PSA progression following radical prostatectomy in patients with prostate cancer. Especially, Group 2 and 3 showed upgrade by presence of tG5. Integrating tG5 into the grade group system will improve the accuracy of patient outcome predictions.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3804-3804
Author(s):  
Elizabeth R. Laber ◽  
Damian A. Laber

Abstract Background: Although thousands of patients (Pts) receive chemotherapy every year in the United States, only few retrospective studies have been done to address the risk factors for chemotherapy (CT) induced neutropenia in patients with cancer. The data in androgen-independent prostate cancer (AIPC) patients is extremely scarce. We decided to perform a retrospective analysis of patients with metastatic AIPC treated with chemotherapy in an open phase II clinical trial looking for predictive factors for neutropenia. Methods: We reviewed the records of all patients with AIPC who completed at least 2 cycles of CT with cyclophosphamide 50 mg/m2, etoposide 50 mg/m2 and estramustine 280 mg orally every night for 14 days out of a 28 day-cycle. We divided the patients into 2 groups according to neutropenia grade 3–4 (Group 1) versus 0–2 (Group 2). Risk factors reviewed included age, number of organs involved with metastases, number of bone metastasis, prior radiotherapy (RT) to the prostate/pelvis, prior number of areas treated with palliative RT, prior CT regimens, baseline PSA, absolute neutrophil count (ANC) and ECOG performance status (PS). Results: See table and figures. Group 1 2 Neutropenia Grade 3–4 0–2 # of Pts 7 11 Age 68 (58–86) 63 (52–74) # organs involved 2.1 1.6 # bone metastases 10.9 9.5 RT prostate/pelvis 0.1 0.4 # palliative RT courses 1 0.6 # prior CT regimens 0.4 0.2 Baseline ANC 3.6 3.8 Baseline PS ECOG 1.3 1.4 Baseline PSA 584 (26–2268) 157 (37–65) Figure Figure Conclusions: Average age and PSA were the only risk factors that were different between the patients who developed severe neutropenia and the ones who did not, albeit not statistically significant. Studies with a larger sample size may detect clinically and statistically significant differences.


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