Hormone-naive Prostate Cancer Patients Research Articles

Prognostic value of the bone scan index using a computer-aided diagnosis system for bone scans in hormone-naive prostate cancer patients with bone metastases.

BackgroundThe bone scan index (BSI) using a computer-aided diagnosis system for bone scans is expected to be an objective and quantitative clinical tool for evaluating bone metastatic prostate cancer. This study aimed to evaluate the pretreatment BSI as a prognostic factor in hormone-naive prostate cancer patients with bone metastases.MethodsThe study included 60 patients with hormone-naive, bone metastatic prostate cancer that was initially treated with combined androgen blockade therapy. The BONENAVI system was used for calculating the BSI. We evaluated the correlation between overall survival (OS) and pretreatment clinicopathological characteristics, including patients’ age, initial prostate-specific antigen (PSA) value, Gleason scores, clinical TNM stage, and the BSI. Cox proportional hazards regression models were used for statistical analysis.ResultsThe median follow-up duration was 21.4 months. Clinical or PSA progression occurred in 37 (61.7 %) patients and 18 (30.0 %) received docetaxel. Death occurred in 16 (26.7 %) patients. Of these deaths, 15 (25.0 %) were due to prostate cancer. The median OS was not reached. In multivariate analysis, age and the BSI were independent prognostic factors for OS. We evaluated the discriminatory ability of our models, including or excluding BSI by quantifying the C-index. The BSI improved the C-index from 0.751 to 0.801 for OS. Median OS was not reached in patients with a BSI ≤1.9 and median OS was 34.8 months in patients with a BSI >1.9 (p = 0.039).ConclusionsThe pretreatment BSI and patients’ age are independent prognostic factors for patients with hormone-naive, bone metastatic prostate cancer.

¹¹C]Choline PET/CT predicts survival in hormone-naive prostate cancer patients with biochemical failure after radical prostatectomy.

Over the last decade, PET/CT with radiolabelled choline has been shown to be useful for restaging patients with prostate cancer (PCa) who develop biochemical failure. The limitations of most clinical studies have been poor validation of [(11)C]choline PET/CT-positive findings and lack of survival analysis. The aim of this study was to assess whether [(11)C]choline PET/CT can predict survival in hormone-naive PCa patients with biochemical failure. This retrospective study included 302 hormone-naive PCa patients treated with radical prostatectomy who underwent [(11)C]choline PET/CT from 1 December 2004 to 31 July 2007 because of biochemical failure (prostate-specific antigen, PSA, >0.2 ng/mL). Median PSA was 1.02 ng/mL. PCa-specific survival was estimated using Kaplan-Meier curves. Cox regression analysis was used to evaluate the association between clinicopathological variables and PCa-specific survival. The coefficients of the covariates included in the Cox regression analysis were used to develop a novel nomogram. Median follow-up was 7.2 years (1.4 - 18.9 years). [(11)C]Choline PET/CT was positive in 101 of 302 patients (33%). Median PCa-specific survival after prostatectomy was 14.9 years (95% CI 9.7 - 20.1 years) in patients with positive [(11)C]choline PET/CT. Median survival was not achieved in patients with negative [(11)C]choline PET/CT. The 15-year PCa-specific survival probability was 42.4% (95% CI 31.7 - 53.1%) in patients with positive [(11)C]choline PET/CT and 95.5% (95% CI 93.5 - 97.5 %) in patients with negative [(11)C]choline PET/CT. In multivariate analysis, [(11)C]choline PET/CT (hazard ratio 6.36, 95% CI 2.14 - 18.94, P < 0.001) and Gleason score >7 (hazard ratio 3.11, 95% CI 1.11 - 8.66, P = 0.030) predicted PCa-specific survival. An internally validated nomogram predicted 15-year PCa-specific survival probability with an accuracy of 80%. Positive [(11)C]choline PET/CT after biochemical failure predicts PCa-specific survival in hormone-naive PCa patients. Prospective studies are warranted to confirm our results before more extensive use of [(11)C]choline PET/CT for prognostic stratification of PCa patients.

799P - Prognostic Value of Computer-Aided Diagnosis System for Bone Scans in Hormone-Naive Prostate Cancer Patients with Bone Metastases

799P - Prognostic Value of Computer-Aided Diagnosis System for Bone Scans in Hormone-Naive Prostate Cancer Patients with Bone Metastases

Enzalutamide monotherapy: One-year extended follow-up of a phase 2 study in hormone-naive prostate cancer patients.

Enzalutamide monotherapy: One-year extended follow-up of a phase 2 study in hormone-naive prostate cancer patients.

Enzalutamide monotherapy: Extended follow-up of a phase II study in hormone-naive prostate cancer patients.

62 Background: The efficacy and safety of enzalutamide (ENZA) monotherapy was assessed in hormone-naive men with prostate cancer (PC; any stage) eligible for androgen-deprivation therapy (ADT). The primary end point of prostate-specific antigen (PSA) response rate (80% or more decline), assessed at 25 weeks (wks), was 92.5% with a median (range) maximum decrease of –99% (–100, –86.5) (Tombal et al. ASCO-GU 2013). Here we present data from the extended follow-up at 49 wks. Methods: In an open-label, single-arm phase II study, men age 18 or older with histologically confirmed PC requiring ADT, non-castrate testosterone (8 nmol/L or more), PSA 2 ng/mL or more at screening and a life expectancy of 12 months or more, received 160 mg ENZA once daily (NCT01302041). Treatment continued until disease progression or unacceptable toxicity. Secondary end points included changes in endocrine levels, metabolic parameters, bone mineral density (BMD), quality of life, and safety. Results: Sixty seven men were enrolled. Median (range) age was 73 (48 to 86); 38.8% had prior metastases; 35.8% and 23.94% had undergone prior prostatectomy and radiotherapy, respectively. Fifty nine men continued treatment beyond wk 25, and 54 completed wk 49. PSA response rate (80% or more reduction from baseline) at wk 49 was 80.6%, with a median (range) maximum decrease of –100% (–100, –86.5). Luteinizing hormone and testosterone were increased from baseline to wk 49 by 215.2% and 101.7%, respectively. Mean changes from baseline for metabolic outcomes at wk 49 were: +5.02% (total cholesterol), +8.86% (triglycerides), –3.54% (HbA1c), and +19.72% (HOMA-IR). Total body BMD was maintained at 49 wks (–0.30% from baseline). The most frequently reported treatment-emergent adverse events (AEs) were gynecomastia (47.8%) and fatigue (38.8%). Seven men had serious AEs, none of which were drug related. Data on patient reported outcomes will be presented. Conclusions: ENZA monotherapy was associated with significant PSA reductions after 49 wks of treatment in men with hormone-naive PC. Endocrine changes and AEs were consistent with potent AR inhibition. Outcomes for all end points at 49 wks were consistent with those reported at 25 wks. Clinical trial information: NCT01302041.

674 Enzalutamide monotherapy: Results from a phase 2 study in hormone naive prostate cancer patients

674 Enzalutamide monotherapy: Results from a phase 2 study in hormone naive prostate cancer patients

Abstract SY24-02: Development of recombinant vaccines for the prevention and therapy of human carcinomas

Abstract SY24-02: Development of recombinant vaccines for the prevention and therapy of human carcinomas

Bone mineral density, pathological fractures and bisphosphonate therapy in prostate cancer patients on androgen deprivation therapy

The aim of the study is to evaluate the changes of bone mineral density (BMD), incidence of pathological fractures and to asses the effect of bisphosphonate therapy in prostate cancer patients (PCa) on androgen deprivation therapy (ADT) with the use of LHRH. In this prospective study bone mass density (BMD) was assessed by dual x-ray absorptiometry (DXA) in 97 PCa patients and 89 patients of compared group. DXA was examined at baseline and patients in the study group were subjected to ADT. PCa patients with osteoporosis were treated by calcium, vitamin D, and bisphosphonate and the subsequent DXA was made after 10 months. All other PCa patients (non-osteoporotic) had DXA examined every 12-14 months. Patients of the study group had significantly lower baseline L1-L4 and total hip BMD (p=0.028, p=0.022). BMD was significantly lower in L1-L4 and total hip (p=0.004, p<0.001, resp.) after 10-14 months and in L1-L4, femoral neck, and total hip (p=0.001, p=0.037, p< 0.001, resp.) after 20-26 months of ADT. After the treatment for osteoporosis with bisphosphonate a significant increase of BMD (p=0.04) was found in a total of 23 patients. Overall, the incidence of fractures after 20-26 months of ADT was 8.5 %. Osteopenia is very common in hormone naive PCa patients. There was a significant loss of BMD after 12 months of ADT which was progressive while the patients were on ADT. Bisphosphonate therapy was effective after 20 months of treatment. The incidence of pathological fractures was 7-fold higher in the study group.

Expression of transcription factor Yin Yang 1 in prostate cancer

The transcription repressor Yin Yang 1 (YY1) is expressed in several human cancer cell lines and its expression correlates with resistance to immune-mediated apoptosis. This study used tissue microarrays to investigate the expression and localization of YY1 in 1364 representative tissue samples from 246 hormone naive prostate cancer patients who underwent radical prostatectomy. Staining intensity and frequency measures for both YY1 nuclear and cytoplasmic expression were higher in neoplastic tissues and in PIN samples compared to matched benign cells (p < 0.0001 for all comparisons). Expression of YY1 is predominantly elevated in early malignancy (PIN), as well as in tumors of intermediate to high morphologic grade (Gleason's grade 3-5). Using multivariate Cox proportional hazards analysis, we observed that low nuclear YY1 staining is an independent predictor of a shorter time to recurrence (p = 0.012). Based on these results, we hypothesize that YY1 may play a role in prostate cancer development; however, decreased YY1 may give metastatic cells a survival advantage. These results may also implicate YY1 as a useful diagnostic and prognostic marker.