scholarly journals 649TiP PRIMORDIUM: A randomized, international, trial-in-progress of adding apalutamide to radiotherapy and an LHRH agonist in high-risk patients with PSMA-PET-positive hormone-sensitive prostate cancer

2021 ◽  
Vol 32 ◽  
pp. S676-S677
Author(s):  
B.A. Hadaschik ◽  
S. Fanti ◽  
P. Ost ◽  
N. Tunariu ◽  
C. de Nunzio ◽  
...  
2008 ◽  
Vol 01 (03) ◽  
Author(s):  
Bernd J Schmitz-Dräger ◽  
Arndt Hartmann ◽  
Gert Hüsgens ◽  
Jack Groskopf ◽  
Jochen Gleissner ◽  
...  

Author(s):  
Daniela A. Ferraro ◽  
Fabienne Lehner ◽  
Anton S. Becker ◽  
Benedikt Kranzbühler ◽  
Ken Kudura ◽  
...  

Abstract Background Positron emission tomography (PET) targeting the prostate-specific membrane antigen (PSMA) has superior sensitivity over conventional imaging (CI) to stage prostate cancer (PCa) and therefore is increasingly used in staging to stratify patients before radical therapy. Whether this improved diagnostic accuracy translates into improved outcome after radical prostatectomy (RPE) has not yet been shown. Therefore, the aim of this study was to compare the oncological outcome after RPE between patients that underwent preoperative staging with CI or PSMA-PET for intermediate and high-risk PCa. Methods We retrospectively selected all patients that underwent RPE for intermediate- or high-risk PCa at our institution before PSMA-PET introduction (between March 2014 and September 2016) and compared the oncologic outcome of patients staged with PSMA-PET (between October 2016 and October 2018). Oncological pre-surgical risk parameters (age, PSA, D’Amico score, biopsy-ISUP, and cT stage) were compared between the groups. Oncological outcome was determined as PSA persistence, nerve-sparing rate, and surgical margin status. Wilcoxon rank-sum, Fisher’s, and chi-square tests where used for statistical testing. Results One hundred five patients were included, 53 in the CI group and 52 in the PSMA-group. Patients in the PSMA group had higher ISUP grade (p < 0.001) and D’Amico score (p < 0.05). The rate of free surgical margins and PSA persistence after RPE was 64% and 17% for the CI and 77% and 6% for the PSMA group (p = 0.15 and 0.13, respectively). Subgroup analysis with high-risk patients revealed PSA persistence in 7% (3/44) in the PSMA group and 25% (7/28) in the CI group (p = 0.04). Limitations include the retrospective design and choline-PET for some patients in the CI group. Conclusion Immediate outcome after RPE was not worse in the PSMA group compared with the CI group, despite a higher-risk cohort. In a comparison of only high-risk patients, PSMA-PET staging was associated with a significantly lower rate of postsurgical PSA persistence.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5117-5117
Author(s):  
B. A. Inman ◽  
B. C. Leibovich ◽  
S. A. Siddiqui ◽  
I. Frank

5117 Background: Prognostic nomograms, scoring tools, and risk tables are rapidly accumulating in the prostate cancer (PCa) literature. It is not always clear to whom these tools should apply and how well they predict the outcomes they were designed to forecast. There is need for independent evaluation of these tools. Methods: We used the Mayo Clinic Radical Prostatectomy Registry, a prospective database of radical prostatectomy (RP) outcomes, to assess tools designed to predict RP outcomes. The validation set included 13,313 RP patients from 1990–2005. There were 3,256 PSA failures, 566 metastases, and 1,599 deaths (301 were due to PCa). We assessed the discrimination, calibration and overall accuracy of prediction tools identified through a structured Pubmed search. Results: Tools varied greatly in terms of complexity, width of prediction interval, and method of presentation. Several tools included non-standard variables and were therefore unevaluable, despite an extensive dataset, leaving the 1999 and 2005 Kattan nomograms, the 1998 and 2001 CDPR scores, and the 2001 GPSM score for analysis. Discrimination (quantitated by the c index) was better for PCa-specific survival and metastases than for PSA failure ( Table ). Kaplan-Meier plots demonstrated clustering of risk groups in most tools, most severely in the higher risk groups of the Kattan nomograms. The calibration plots of most tools (excepting GPSM) had a serious discordance between observed and predicted outcomes in the lower probability ranges. This meant that most tools gravely overestimated the probability of RP failure in high-risk patients, by up to 4- fold. Conclusions: The tools showed moderate discriminatory ability for PSA failure but performed much better for non-surrogate outcomes. Most tools (excepting GPSM) were miscalibrated in high risk patients and dramatically underestimated the efficacy of surgery in this cohort. Prognostic tools may not be as accurate as previously reported. [Table: see text] No significant financial relationships to disclose.


2021 ◽  
Vol 11 ◽  
Author(s):  
Xiao-Xiao Guo ◽  
Hao-Ran Xia ◽  
Hui-Min Hou ◽  
Ming Liu ◽  
Jian-Ye Wang

ObjectiveWe aimed compare the oncologic outcomes of radical prostatectomy (RP) with those of external beam radiotherapy (EBRT), brachytherapy (BT), or EBRT + BT (EBBT) in elderly patients with localised prostate cancer (PCa).MethodsLocalised PCa patients aged ≥70 years who underwent RP, EBRT, BT, or EBBT between 2004 and 2016 were identified from the Surveillance, Epidemiology, and End Results database. Multivariable competing risks survival analyses were used to estimate prostate cancer-specific mortality (CSM) and other-cause mortality (OCM). Subgroup analyses according to risk categories were also conducted.ResultsOverall, 14057, 37712, 8383, and 5244 patients aged ≥70 years and treated with RP, EBRT, BT, and EBBT, respectively, were identified. In low- to intermediate-risk patients, there was no significant difference in CSM risk between RP and the other three radiotherapy modalities (all P &gt; 0.05). The corresponding 10-year CSM rates for these patients were 1.2%, 2.3%, 2.0%, and 1.8%, respectively. In high-risk patients, EBRT was associated with a higher CSM than RP (P = 0.003), whereas there was no significant difference between RP and BT or RP and EBBT (all P &gt; 0.05). The 10-year CSM rates of high-risk patients in the RP, EBRT, BT, and EBBT groups were 7.5%, 10.2%, 8.3%, and 7.6%, respectively. Regarding OCM, the risk was generally lower in RP than in the other three radiotherapy modalities (all P &lt; 0.001).ConclusionsAmong men aged ≥70 years with localised PCa, EBRT, BT, and EBBT offer cancer-specific outcomes similar to those of RP for individuals with low- to intermediate-risk disease. In patients with high-risk disease, EBBT had outcomes equally favourable to those of RP, but RP is more beneficial than EBRT. More high-quality trials are warranted to confirm and expand the present findings.


Medicina ◽  
2007 ◽  
Vol 43 (11) ◽  
pp. 843
Author(s):  
Kęstutis Vaičiūnas ◽  
Stasys Auškalnis ◽  
Aivaras Matjošaitis ◽  
Antanas Mickevičius ◽  
Ramūnas Mickevičius ◽  
...  

Our purpose was to evaluate the relevance of repeat laterally directed sextant prostate biopsy for detection of prostate cancer in high-risk patients. Material and methods. Our study included 195 men at high risk for prostate cancer (elevated prostatespecific antigen level and/or abnormal prostate detected by digital rectal examination). We consulted the patients in outpatient department of Kaunas University of Medicine Hospital during 2003–2007. We performed transrectal ultrasound-guided laterally directed sextant prostate biopsy in every patient. For the patients with benign histological findings and increased risk of prostate cancer, laterally directed sextant biopsies were repeated. Results. Prostate cancer was detected in 30.3% of patients (59/195) on the first prostate biopsy, in 13.1% (11/84) on the second prostate biopsy, in 10.3% (4/39) on the third, and in 7.7% (1/13) on the forth biopsy. After all biopsies, prostate cancer was detected in 38.5% (75/195) of patients, and it differed significantly from the percentage of prostate cancer cases detected on the first biopsy (30.3%, P=0.04). We detected 78.7% (59/75) of all prostate cancer cases by the first laterally directed sextant prostate biopsy. The rest 21.3% (16/75) of cases we detected by repeat biopsies. The second laterally directed sextant prostate biopsy revealed additional 14.6% (n=11) of prostate cancer cases and increased the detection of prostate cancer to 93.3% (70/75). At the time of the first prostate biopsy, prostate cancer was diagnosed most frequently when patients had both risk factors: elevated prostate-specific antigen level and abnormal digital prostate examination; prostate cancer was diagnosed in 45.3% of these patients. The odds ratio to detect prostate cancer by the first biopsy in patients with elevated prostate-specific antigen level and abnormal digital prostate examination was 3.7, and odds ratio to detect prostate cancer by repeat biopsies was 4.7. Conclusions. Repeat ultrasound-guided laterally directed sextant prostate biopsies reveal more cases of prostate cancer as compared to the first prostate biopsy. The majority of prostate cancer cases (93.3%) are detected by the first and second laterally directed sextant prostate biopsies. After the first negative prostate biopsy, we recommend to repeat prostate biopsy in high-risk patients.


2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 113-113
Author(s):  
Kenneth Gerard Nepple ◽  
Gurdarshan S Sandhu ◽  
Dorina Kallogjeri ◽  
Seth A. Strope ◽  
Robert L. Grubb ◽  
...  

113 Background: Multiple definitions of high risk prostate cancer exist. Studies have primarily correlated these definitions with biochemical recurrence and not with survival. We applied six previously described high risk definitions to men treated with radical prostatectomy and evaluated their ability to predict survival outcomes in a multi-institutional cohort. Methods: The study population included 6477 men treated with radical prostatectomy between 1995 and 2005 and followed for a median of 67 months. The six high risk definitions were 1) preoperative PSA≥20ng/ml, 2) biopsy Gleason score 8-10, 3) clinical stage≥T2c, 4) clinical stage T3, 5) D’Amico definition, or 6) National Comprehensive Cancer Network definition. Survival was evaluated with the Kaplan-Meier method to generate unadjusted prostate cancer survival estimates. To control for the competing risks of age and comorbidity, multivariable Cox proportional hazard regression models were used to estimate the hazard ratio for prostate cancer specific mortality (PCSM) and overall mortality (OM) in high risk patients compared to low/intermediate risk. Results: High risk patients comprised between 0.7% (cT3) and 8.2% (D’Amico) of the study population. The 10-year Kaplan Meier prostate cancer survival estimates varied from 89.7% for PSA≥20 to 69.7% for cT3. On multivariable analysis controlling for age and comorbidity, high risk prostate cancer (of all definitions) had an increased risk of PCSM compared to low/intermediate risk with a hazard ratio (HR) ranging from 4.38 for PSA≥20 to 19.97 for cT3 (all p<0.0001). For OM, again controlling for age and comorbidity, high risk patients of all definitions except preoperative PSA≥20 (HR=0.98, p=0.99) were associated with increased risk of OM (HR range: 1.72 for D’Amico, 1.73 for stage≥T2c, 1.88 for NCCN, 2.63 for Gleason 8-10, 3.31 for cT3; all p<0.01). Conclusions: In a contemporary cohort of men with high risk prostate cancer treated with radical prostatectomy, the majority of men experienced long term prostate cancer survival. However, heterogeneity in survival outcomes existed based on the definition of high risk used. Clinical stage T3 and high Gleason score were most strongly associated with PCSM and OM.


2017 ◽  
Vol 4 ◽  
pp. 297-303
Author(s):  
Gregory S. Merrick ◽  
Robert W. Galbreath ◽  
Wayne M. Butler ◽  
Ryan Fiano ◽  
Edward Adamovich

2005 ◽  
Vol 23 (27) ◽  
pp. 6561-6568 ◽  
Author(s):  
Almudena Zapatero ◽  
Francisco Valcárcel ◽  
Felipe A. Calvo ◽  
Rosa Algás ◽  
Amelia Béjar ◽  
...  

Purpose Multicenter study conducted to determine the impact on biochemical control and survival of risk-adapted androgen deprivation (AD) combined with high-dose three-dimensional conformal radiotherapy (3DCRT) for prostate cancer. Results of biochemical control are reported. Patients and Methods Between October 1999 and October 2001, 416 eligible patients with prostate cancer were assigned to one of three treatment groups according to their risk factors: 181 low-risk patients were treated with 3DCRT alone; 75 intermediate-risk patients were allocated to receive neoadjuvant AD (NAD) 4-6 months before and during 3DCRT; and 160 high-risk patients received NAD and adjuvant AD (AAD) 2 years after 3DCRT. Stratification was performed for treatment/risk group and total radiation dose. Results After a median follow-up of 36 months (range, 18 to 63 months), the actuarial biochemical disease-free survival (bDFS) at 5 years for all patients was 74%. The corresponding figures for low-risk, intermediate-risk, and high-risk disease were 80%, 73%, and 79%, respectively (P = .847). Univariate analysis showed that higher radiation dose was the only significant factor associated with bDFS for all patients (P = .0004). When stratified for treatment group, this benefit was evident for low-risk patients (P = .009) and, more interestingly, for high-risk patients treated with AAD. The 5-year bDFS for high-risk patients treated with AAD was 63% for radiation doses less than 72 Gy and 84% for those ≥ 72 Gy (P = .003). Conclusion The results of combined AAD plus high-dose 3DCRT are encouraging. To our knowledge, this is the first study showing an additional benefit of high-dose 3DCRT when combined with long-term AD for unfavorable disease.


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