Higher PSA Values Research Articles

Role of transrectal ultrasound and MRI in the diagnosis and localisation of carcinoma prostate - A comparison of diagnostic efficacy of trus versus MRI

In this study, we wanted to correlate the findings of TRUS and MRI with regard to the diagnosis and localization of carcinoma prostate and local staging of carcinoma prostate. Our study included 43 men, with age ranging from 49 to 76 years. They underwent TRUS, MRI and TRUS guided twelve core biopsies after being suspected with prostate cancer based on high PSA values (greater than 4.0 ng /ml) or abnormal DRE findings. This study was conducted from April 2018 -June 2019. Imaging findings were confirmed with histopathology. TRUS used for the detection of malignancy had sensitivity, specificity, PPV and NPV as 69.70%, 80 %, 92% and 44.44 % respectively. The values were 63.16%, 83.33%, 75.00%, and 74.07% for the sensitivity, specificity, PPV and NPV of TRUS respectively for the detection of ECE. rnFor the detection of malignancy, the sensitivity, specificity, PPV and NPV of MRI was 87.88%, 70%, 90.63% and 63.64% respectively and 85.71%, 89.66%, 80.00% and 92.86% for the sensitivity, specificity, PPV and NPV of MRI respectively for detection of SVI. For detection of extracapsular extension (ECE), MRI had sensitivity, specificity, PPV and NPV of 78.95%, 83.33%, 78.95% and 83.33% respectively. When compared to TRUS, MRI is more useful in the diagnosis and accurate staging of prostate cancer. MRI can improve the false-negative biopsies resulting due to the inability of TRUS in detection of abnormal areas.

MiR-375 and miR-21 as Potential Biomarkers of Prostate Cancer: Comparison of Matching Samples of Plasma and Exosomes

MiR-21 and miR-375 have been reported as dysregulated in prostate cancer (PCa) in multiple previous studies. Still, variable or even opposing data for the expression of these microRNAs in PCa were found, and their potential biomarker properties remain elusive. In an attempt to clarify their significance as PCa biomarkers, as well as to compare different types of specimens as a source of relevant microRNAs, we used plasma and matching plasma-derived exosomes from patients with PCa and patients with benign prostatic hyperplasia (BPH). Plasma and exosomes were obtained from 34 patients with PCa and 34 patients with BPH, and their levels of expression of miR-21 and miR-375 were determined by RT-qPCR. We found no significant difference in the level of expression of these microRNAs in plasma and exosomes between patients with PCa and BPH. The level of exosomal miR-21 was elevated in PCa patients with high serum PSA values, as well as in patients with aggressive PCa, while for plasma samples, the results remained insignificant. For miR-375, we did not find an association with the values of standard prognostic parameters of PCa, nor with cancer aggressiveness. Therefore, our results support the potential prognostic role of exosomal miR-21 expression levels in PCa.

Predictive Effect of EPS Results on Prostate Cancer Detection in Patients with High PSA Values

Predictive Effect of EPS Results on Prostate Cancer Detection in Patients with High PSA Values

MP43-08 ACTIVE SURVEILLANCE FOR PROSTATE CANCER: UPTAKE OVER TIME AND THE IMPACT OF AN ORGANIZED PROTOCOL

You have accessJournal of UrologyCME1 May 2022MP43-08 ACTIVE SURVEILLANCE FOR PROSTATE CANCER: UPTAKE OVER TIME AND THE IMPACT OF AN ORGANIZED PROTOCOL Sebastiaan Remmers, and Monique Roobol Sebastiaan RemmersSebastiaan Remmers More articles by this author , and Monique RoobolMonique Roobol More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002609.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The European Randomized Study of Screening for Prostate Cancer (ERSPC) showed that PSA-based screening coincides with overdiagnosis and overtreatment. Active Surveillance (AS) was initiated to reduce the harm of overtreatment. However, the rate of uptake of AS is highly heterogeneous around the world. Here, we look at the uptake of AS over time. Specifically, we assessed whether the initiation of an organized protocol increased the rate of men opting for AS and looked at differences between screening and clinical setting. METHODS: Data include diagnoses in the period 1993-2013 in men aged ≤70 yr diagnosed within ERSPC Rotterdam and eligible for AS according to the Prostate cancer Research International: Active Surveillance (PRIAS) pre-MRI criteria (Gleason 6, PSA <10 ng/ml, ≤cT2a). The number of PRIAS eligible men was compared against all men with low-risk disease in both arms of the trial and we assessed the choice of initial treatment for PRIAS eligible men before and after 2006 (the year PRIAS was initiated). RESULTS: In the study period, 962 men in the screening (S-) arm and 265 men in the control (C-) arm were diagnosed with cT1c/cT2a Gleason 6 disease (Tab/Fig). The percentage of PRIAS eligible men in this group is very different: 91% in the S-arm and 63% in the C-arm, reflecting lead time (lower PSA and tumor load). In the 90s and before PRIAS was initiated (i.e. <2006), 22% of all PRIAS eligible men in the S- arm opted for AS and 77% for radical prostatectomy (RP) / radiotherapy (RT); in the C- arm 27% opted for AS and 68% for RP/RT. From 2006 (initiation of PRIAS) till 2013 63% of the PRIAS eligible men in the S-arm opted for AS and 34% for RP/RT; in the C- arm 47% of the PRIAS eligible men opted for AS and 47% for RP/ RT. A difference most likely due to (although eligible for AS according to the PRIAS criteria) higher PSA values at diagnosis in the C- arm (median 6.2 ng/ml) than in the S-arm (median 3.9 ng/ml). CONCLUSIONS: In conclusion, PSA-based screen-detected low risk PCa is in general suitable for an AS approach. The initiation and awareness of an organized protocol for AS has increased the uptake in men diagnosed with low-risk PCa, but there is certainly still room for improvement. Since (opportunistic) early detection practices are ubiquitous, next to avoiding overdiagnosis, the use of AS in clinical practice should be strongly encouraged. Source of Funding: No © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e743 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sebastiaan Remmers More articles by this author Monique Roobol More articles by this author Expand All Advertisement PDF DownloadLoading ...

18F]Fluciclovine PET/CT Improves the Clinical Management of Early Recurrence Prostate Cancer Patients.

Simple SummaryIn the challenge between increasingly sensitive PET radiopharmaceuticals for the evaluation of prostate cancer patient in biochemical relapse, the choice of the most accurate PET tracer must be guided by literature data, but above all tailored to the patient’s profile. In describing our single-center experience, we aimed to identify biochemical and clinical–histological factors to be considered in patient selection and the semiquantitative parameters that can help the interpretation of malignant from benign lesions, in order to optimize the performance of this imaging method. These data in combination with a significant impact on therapeutic decision making can be useful to further validate the [18F]Fluciclovine PET/CT clinical application.We investigated the [18F]Fluciclovine PET/CT reliability in the early detection of recurrent prostate cancer (PCa) and its impact on therapeutic decision making. We retrospectively analyzed 58 [18F]Fluciclovine PET/CT scans performed to identify early PCa recurrence. Detection rate (DR) and semiquantitative analysis were evaluated in relation to biochemical and clinical–histological features. Clinical follow-up data were collected and considered as gold standard to evaluate sensitivity, specificity, accuracy, positive and negative predictive value (PPV, NPV). The impact of [18F]Fluciclovine PET/CT on clinical management was also assessed. Overall DR resulted as 66%, while DR was 53%, 28%, and 7% in prostate/bed, lymph nodes, and bone, respectively. DR significantly increased with higher PSA values (p = 0.009) and 0.45 ng/mL was identified as the optimal cut-off value. Moreover, SUVmax and SUVmean resulted significant parameters in interpreting malignant from benign findings. [18F]Fluciclovine PET/CT reached a sensitivity, specificity, PPV, NPV, and accuracy of 87.10%, 80.00%, 87.10%, 80.00%, and 84.31%, respectively. Therapeutic strategy was changed in 51% of patients. Our results support [18F]Fluciclovine PET/CT as a reliable tool for early restaging of PCa patients, especially for local recurrence detection, leading to a significant impact on clinical management. Semiquantitative analysis could improve specificity in interpreting malignant from benign lesions.

The changing landscape of treatment and survival for men with castration-resistant prostate cancer in the era of novel treatments.

67 Background: Several therapies for men with castration-resistant prostate cancer (CRPC) have become available since 2010 with the hope of prolonging survival for those at the end stages of their disease. Little is known about the survival of men who receive novel therapies in the real world and the disease burden of patients initiating treatment for CRPC between 2010 and 2017. Methods: Using the Veterans Health Affairs Corporate Data Warehouse, we identified Veterans with CRPC who received first-line therapy for castration-resistant disease between 2010-2017. Therapies included ketoconazole, docetaxel, abiraterone, and enzalutamide since &gt; 99% of patients treated for CRPC received one of these therapies first-line for CRPC. We used a Cox model to calculate the overall survival of patients from time of first CRPC treatment for each year. We then adjusted for patient and disease characteristics, such as starting PSA level, and prognostic group at the start of treatment based on hemoglobin, alkaline phosphatase, and albumin levels. Results: In a cohort of 4,998 men started on treatment for CRPC between 2010-2017, survival from start of first-line treatment gradually increased between 2010-2017. In 2010, when 38% of men received docetaxel first-line and 62% ketoconazole, the probability of surviving at least one year from start of first-line therapy was 64%. In 2017, when the landscape of first-line treatment had changed (49% abiraterone, 9% docetaxel, 41% enzalutamide, 1% ketoconazole) one-year survival from start of first therapy improved to 72%. The unadjusted hazard ratio (HR) for an additional calendar year was 0.93 (95% confidence interval [CI], 0.91-0.95). Men started on first-line CRPC therapy in 2010 had worse prognostic labs at the start of therapy, suggesting worse disease, and had a higher PSA value at the start of therapy compared to those started on CRPC therapy in 2017 (median PSA 55.1 in 2010 vs 27.8 in 2017, p-value &lt; 0.01). When adjusting for disease characteristics, the improvement in survival we saw between 2010 and 2017 was diminished with adjusted HR for an additional calendar year of 0.97 (95% CI, 0.94-1.00). Conclusions: With the development of novel therapies, the survival of patients with similar disease burden should gradually improve over time. Although we did see a modest improvement in survival between 2010-2017, this improvement was mitigated when adjusting for disease severity, suggesting that some of the improvement in survival may be affected by a lead-time bias—treating patients earlier in their CRPC.

Evaluation of hybrid PET/CT imaging with the 68Ga-labelled PSMA ligand in patients with prostate cancer and biochemical progression in the low-range values of PSA after radical prostatectomy

Introduction: Currently 68 Ga-PSMA PET/CT is making a significant shift in the diagnosis, staging and restaging of prostate cancer (PC) patients. Мany questions have been raised concerning the indications and the sensitivity of the method. Most of them are related to the PSA values in biochemical progression, specifically in the low PSA values of up to 2.00 ng/mL. Aim: The aim of this study was to analyze the influence of PSA values in biochemical progression on 68 Ga-PSMA PET/CT sensitivity, detection rate and the association with regional or metastatic lesions incidence in patients after radical prostatectomy (RP) with a focus on the impact of the lower ranges of the PSA values. Material and Methods: We performed a retrospective analysis in 144 consecutive patients with radical prostatectomy (RP) who underwent 68 Ga-PSMA PET/CT from July 2019 to February 2020. The patients were divided into six groups according to the PSA value: 1) ≤ 0.040 ng/mL; 2) 0.041–0.160 ng/mL; 3) 0.161–0.500 ng/mL; 4) 0.501–1.0 ng/mL; 5) 1.001–2.00 ng/mL; 6) &gt; 2.00 ng/mL. Results and Discussion: The mean age of the patients was 67.3 (7) years and the mean PSA level was 11.0 (52.28) ng/mL. A total of 62 patients (43.1%) showed at least one positive lesion. 68 Ga-PSMA PET/CT detection rate varied into the different groups between 12.0% and 94.0%. There was a significant relationship between the PSA level and the ability of 68 Ga-PSMA PET/CT to detect the lesions. Local recurrence was determined in patients with higher PSA values. Regional metastatic lymph nodes incidence in the 6 groups was between 17.0% and 50.0%. Bone metastases were most commonly diagnosed in patients with low PSA levels. Distant lymph nodes involvement in the studied groups ranged between 0.0% and 75.0%. Distant metastases were detected most commonly in patients with low levels of PSA. The PSA-based assessment of the overall sensitivity and specificity of 68 Ga-PSMA PET/CT was 58.0% and 87.0%, respectively. Sensitivity of 15.0% was found in the group with the lowest mean PSA levels. Conclusion: Tumor detection rate is positively associated with PSA levels. Biochemical progression after RP is more commonly related to distant metastases, specifically bone metastases in patients with lower levels of PSA.

MP30-03 POSITIVE PREDICTIVE VALUE OF MPMRI IN MEN UNDER ACTIVE SURVEILLANCE: CAN THE BIOPSY HISTORY INFLUENCE RADIOLOGICAL ASSESSMENT?

MP30-03 POSITIVE PREDICTIVE VALUE OF MPMRI IN MEN UNDER ACTIVE SURVEILLANCE: CAN THE BIOPSY HISTORY INFLUENCE RADIOLOGICAL ASSESSMENT?

Factors influencing treatment of veterans with advanced prostate cancer.

Treatments for metastatic castration-resistant prostate cancer (CRPC) differ in toxicity, administration, and evidence. In this study, clinical and nonclinical factors associated with the first-line treatment for CRPC in a national delivery system were evaluated. National electronic laboratory and clinical data from the Veterans Health Administration were used to identify patients with CRPC (ie, rising prostate-specific antigen [PSA] on androgen deprivation) who received abiraterone, enzalutamide, docetaxel, or ketoconazole from 2010 through 2017. It was determined whether clinical (eg, PSA) and nonclinical factors (eg, race, facility) were associated with the first-line treatment selection using multilevel, multinomial logistic regression. The average marginal effects (AMEs) were calculated of patient, disease, and facility characteristics on ketoconazole versus more appropriate CRPC therapy. There were 4998 patients identified with CRPC who received first-line ketoconazole, docetaxel, abiraterone, or enzalutamide. After adjustment, increasing age was associated with receipt of abiraterone (adjusted odds ratio [aOR], 1.07; 95% credible interval [CrI], 1.06-1.09) or enzalutamide (aOR, 1.10; 95% CrI, 1.08-1.11) versus docetaxel. Greater preexisting comorbidity was associated with enzalutamide versus abiraterone (aOR, 1.53; 95% CrI, 1.23-1.91). Patients with higher PSA values at the start of treatment were more likely to receive docetaxel than oral agents and less likely to receive ketoconazole than other oral agents. African American men were more likely to receive ketoconazole than abiraterone, enzalutamide, or docetaxel (AME, 2.8%; 95% CI, 0.7%-4.9%). This effect was attenuated when adjusting for facility characteristics (AME, 1.9%; 95% CI, -0.4% to 4.1%). Clinical factors had an expected effect on the first-line treatment selection. Race may be associated with the receipt of a guideline-discordant first-line treatment.

Homeopathic Remedies Regulate Pathological Pathways in Patients with Endocrine Cancer

Desperate cancer patients very often prefer alternative medicine as homeopathy after unsuccessful treatment by radiation and chemotherapy. After the detection of magnetic photons in homeopathic remedies by Lenger homeopathy can be seen as an energetic medicine. According to Lenger‘s biochemical and biophysical model of homeopathy 15 patients having cancer in the endocrine system, lymph nodes and relapses were treated.They all reported a hypofunction of the thyroid at the beginning of their illness. To achieve a normally working thyroid, all patients got an unusual mixture of 50µg potassium jodide, 55mg calcium and the corresponding highly potentised homeopathic remedies in 50M as Iodium, Calcium-salts for the incorporation and regulation of calcium and iodium. The additional therapy consisted of the highly potentised gland, its specific hormone and potentised substrates of the fatty acid metabolism. After getting the unusual thyroid-mixture the woman with tongue cancer was healed completely.The nodes in the breast of 5 women vanished completely after application of 50M of Prolactin, Glandula pituitaria; for the remove of the precipitated prolactin Urea pura, Uricum acidum, Picricum acidum, Nitricum acidum. Highly potentised steroidhormones were given to a woman with relapses in the lung having had breast cancer, ovarian and uterine carcinoma, to the woman with lymphnode disease and fatty tissue in the abdomen and to the men with high PSA values in combination with high potencies of the substrates of the fatty acid metabolism. The woman improved for three years. The PSA-values of the men became normal. Both women with severe cancer and metastases in the bones lived more than 6 years in contrast to the doctors‘ prediction that they have only 2-4 months to live. Lenger’s unusual homeopathic therapy consisting of substances and high homeopathic remedies of the ill endocrine glands was able to improve successfully the cancer of the endocrine system.

Enzalutamide versus Abiraterone Acetate as first-line treatment of castration resistant metastatic prostate cancer in geriatric (≥75) patients

Introduction: The efficacy and tolerability of Enzalutamide and Abiraterone Acetate have been reported in elderly patients with metastatic castration resistant prostate cancer (mCRPC). However, there is no randomized study directly comparing antitumor effects between these 2 agents in geriatric patients. We aimed to evaluate the efficacy of Enzalutamide (ENZA) and Abiraterone Acetate (AA) as a first-line treatment of mCRPC in elderly patients. Materials and methods: The geriatric patients (≥75 years of age) with a diagnosis of mCRPC and treated with first-line ENZA or AA were included. The impacts of clinical parameters and treatment modalities on overall survival (mOS) were analyzed retrospectively and Cox regression analysis was performed. Results: One hundred thirty-four mCRPC patients (77 in AA, 57 in ENZA), with a median age of 81 (75–93) were analyzed. The patient and disease characteristics were similar between arms. While there were more grade 1–2 toxicities in AA arm (45.5% vs 17.5%, P = 0.001), the discontinuation due to toxicity was similar between groups (8.5% vs 5.9%, P = 0.81). The mOS was 18.0 months (95% CI, 15.2–20.7) in AA, and 20.0 months (95% CI, 4.4–35.5) in ENZA arm (P = 0.47). In multivariate analysis, high Gleason score (≥8) (HR: 2.0 (95% CI, 1.1–3.4), P = 0.009) and high initial PSA values (≥100 ng/mL) (HR: 2.6 (95% CI, 1.5–4.8), P = 0.001) were poor prognostic factors. The choice of AA vs ENZA was insignificant as a predictor of OS (HR: 0.87 (95%CI, 0.48–1.56), P = 0.65). Conclusion: In the first-line treatment of mCRPC in elderly (≥75) patients, AA and ENZA showed similar results in terms of mPFS and mOS. The clinical impacts of second-generation androgen receptor pathway inhibitors in the elderly population should be tested in prospective randomized studies.

Biochemical Persistence of Prostate-Specific Antigen After Robot-Assisted Laparoscopic Radical Prostatectomy: Tumor Localizations Using PSMA PET/CT Imaging.

Since the introduction of radiolabeled prostate-specific membrane antigen (PSMA) PET/CT, the ability to visualize recurrent prostate cancer has improved substantially. However, diagnostic accuracy is largely lacking for radiolabeled PSMA PET/CT in patients with biochemical persistence (BCP; that is, persistently measurable prostate-specific antigen [PSA] values after robot-assisted laparoscopic radical prostatectomy [RARP]). Therefore, the aim of this study was to determine the role of PSMA (i.e.,18F-DCFPyL or 68Ga-PSMA-11) PET/CT imaging in patients who experience BCP after RARP and to evaluate the sites of persistent disease on PSMA PET/CT. Methods: In total, 150 consecutive patients with BCP after RARP who underwent radiolabeled PSMA PET/CT imaging were retrospectively evaluated. BCP was defined as any detectable first serum PSA value after RARP (≥0.1 ng/mL) at least 6 wk after surgery, in the absence of an undetectable PSA value after RARP. A multivariable logistic regression analysis was performed to identify predictors for the detection of metastases outside the prostatic fossa (≥miN1) on PSMA PET/CT. Results: PSMA PET/CT was performed at a median PSA value of 0.60 ng/mL (interquartile range, 0.3-2.4) after a median of 6 mo (interquartile range, 4-10) after RARP. In total, 101 of 150 patients (67%) had lesions with PSMA expression on PET/CT, and 89 of 150 (59%) had lesions with increased PSMA expression sites outside the prostatic fossa. Moreover, 39 of 150 patients (26%) had PSMA-positive lesions outside the pelvis. On multivariable analysis, higher PSA values after RARP (P = 0.004) and positive pathologic lymph node status (P = 0.006) were independent predictors for ≥miN1. Conclusion: In the presence of BCP, a high proportion of patients already had disease metastatic to the pelvic lymph nodes or showed evidence of distant metastases, as indicated by PSMA PET/CT. Higher PSA levels after RARP and positive pathologic lymph node status were significantly associated with metastases outside the prostatic fossa. In patients with BCP, PSMA PET/CT imaging is warranted to guide salvage treatment strategies.

SC26 - infertile men have higher PSA values than aged-matched fertile controls: Potential implications for personalized prevention strategies

SC26 - infertile men have higher PSA values than aged-matched fertile controls: Potential implications for personalized prevention strategies

Concordance Between Biopsy and Radical Prostatectomy Gleason Scores: Evaluation of Determinants in a Large-Scale Study of Patients Undergoing RARP in Belgium.

To determine whether Gleason scores were concordant between prostate biopsies (bGS) and the definitive resection specimen (pGS) excised with robot-assisted radical prostatectomy (RARP); to identify clinical and pathological factors that might predict upgrading; and to evaluate how upgrading affected outcome. Between 2009 and 2016, 25 Belgian centers participated in collecting prospective data for patients that underwent RARP. We analyzed the concordance rate between the bGS and the pGS in 8021 patients with kappa statistics, and we compared concordance rates from different centers. We assessed the effect of several clinical and pathological factors on the concordance rate with logistic regression analysis. The concordance rate for the entire population was 62.9%. Upgrading from bGS to pGS occurred in 27.3% of patients. The number of biopsies was significantly associated with concordance. Older age (>60 y), a higher clinical T stage (≥cT2), a higher PSA value at the time of biopsy (>10ng/ml), and more time between the biopsy and the radical prostatectomy were significantly associated with a higher risk of upgrading. Positive margins and PSA relapse occurred more frequently in upgraded patients. Center size did not significantly affect the concordance rate (p = 0.40).This prospective, nationwide analysis demonstrated a Gleason score concordance rate of 62.9%. Upgrading was most frequently observed in the non-concordant group. We identified clinical and pathological factors associated with (non)-concordance. Upgrading was associated with a worse oncological outcome. Center volume was not associated with pathological accuracy.

416 - Infertile men have higher PSA values than aged-matched fertile controls: Potential implications for personalized prevention strategies

416 - Infertile men have higher PSA values than aged-matched fertile controls: Potential implications for personalized prevention strategies

CARD: Overall survival (OS) analysis of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel versus abiraterone or enzalutamide.

5569 Background: The CARD trial (NCT02485691) compared cabazitaxel vs. an androgen receptor targeted agent (ART; abiraterone/enzalutamide) in mCRPC previously treated with docetaxel and the alternative ART (abiraterone/enzalutamide), in any order. These post hoc analyses assessed OS from various time points and the impact of prognostic factors. Methods: Patients with mCRPC previously treated with docetaxel and progressing ≤ 12 months on prior abiraterone/enzalutamide were randomized 1:1 to cabazitaxel (25 mg/m2 IV Q3W + daily prednisone + prophylactic G-CSF) vs. abiraterone (1000 mg PO + daily prednisone) or enzalutamide (160 mg PO). OS was calculated from date of diagnosis of metastatic disease, date of mCRPC, and start of 1st, 2nd or 3rd life-extending therapy (LET). A stratified multivariate Cox regression analysis assessed the impact of 14 prognostic factors on OS using a stepwise model selection approach with a significance level of 0.10 for entry into the model and 0.05 for removal. Results: In the CARD study (N = 255), median OS was longer with cabazitaxel vs. abiraterone/enzalutamide (13.6 vs 11.0 months; HR 0.64, 95% CI 0.46–0.89; p = 0.008). OS was numerically improved for cabazitaxel vs. abiraterone/enzalutamide when assessed from the time of diagnosis of metastatic disease or mCRPC, or from start of 1st or 2nd LET (Table). In the multivariate analysis, low hemoglobin, high baseline neutrophil to lymphocyte ratio, and high PSA values at baseline were associated with worse OS. In presence of these factors, the OS benefit observed with cabazitaxel versus abiraterone/enzalutamide remained significant (HR 0.63, 95% CI 0.42–0.94, p = 0.022). Conclusions: Cabazitaxel numerically improved OS vs. abiraterone/enzalutamide in patients with mCRPC previously treated with docetaxel and the alternative ART (abiraterone/enzalutamide), whatever the time point considered. The robustness of this OS benefit was confirmed by stratified multivariate analysis. Sanofi funded. Clinical trial information: NCT02485691 . [Table: see text]

MP13-17 THE EFFECT OF STAGING WITH 68GA-PSMA PET/CT IMAGING ON CLINICAL DECISION FOR TREATMENT PROTOCOL OF HIGH RISK PROSTATE CANCER PATIENTS

INTRODUCTION AND OBJECTIVE: Staging in high risk prostate cancer patients (Gleason score >7, PSA >20 ng/mL, clinical stage T2c – 3a) with 68Ga-PSMA PET/CT is useful for detecting metastatic disease especially valuable for oligometastatic disease. It has shown to change the treatment protocol in patients with biochemical recurrence (BCR) however, there is still less data with the patients for recently diagnosed prostate cancer or staging. METHODS: Recently diagnosed prostate cancer patients suspected with metastatic disease, additionally patients with findings either Gleason score of higher than 7 or higher PSA values were included in our study. Fifty-seven patients with prostate cancer were scanned for staging. Between 3,6-5,5 mCi 68Ga-PSMA was injected. Patients were scanned 60 minutes after injection. Images were evaluated by two nuclear medicine specialists. Furthermore, two different urologists separately evaluated all patients for treatment protocol. First, the evaluation is done without PSMA PET/CT results and for second evaluation they have been given the results of the PSMA scans. RESULTS: Patient ages were between 36-86 years and mean PSA value was 152 (4,1-1957 ng/ml). All Gleason scores were higher than 7, except seven patients who had PSA values of >20ng/ml. 45% of the patients had positive findings for lymph node metastases; 28% of the patients had distant metastasis. Between 41% and 50% of changing rates were calculated for the treatment protocols after PSMA scan results. CONCLUSIONS: Several studies have already revealed the use of 68Ga-PSMA PET/CT in prostate cancer with the suspect of BCR. However, there is still debate about the use of PSMA imaging in staging prostate cancer patients. The patients in our series showed the contribution of PSMA imaging is not negligible with the change rates of 41-50% in treatment protocol. However further discussion with higher patient numbers is needed for the cost-effectiveness. Source of Funding: The authors declare no source of funding.

MP09-04 PROSTATE HEALTH INDEX DENSITY (PHID) IS MORE PREDICTIVE OF DISEASE RE-CATEGORIZATION THAN MULTIPARAMETRIC MRI IN MEN UNDERGOING ACTIVE SURVEILLANCE

INTRODUCTION AND OBJECTIVE: Prostate Health Index (phi) is an FDA-approved serum biomarker that is calculated using total PSA, free PSA, and pro2PSA in an algorithm to estimate the likelihood of having prostate cancer (PCa) and high-grade disease on biopsy. The phi value can be divided by the prostate volume to calculate a phi density (phiD) that may be even more accurate for detecting high grade tumors. Although phiD has been described, its utility for identifying men at risk of up-grading during active surveillance (AS) has not been evaluated or compared against other commonly used metrics. METHODS: Men who had a phi value and multiparametric prostate MRI (mpMRI), with clinical stage ≤T2a and Gleason grade group 1 (GG1) cancer on a diagnostic biopsy, and were enrolled in an IRB-approved AS program were included. To avoid sampling error bias, any subject who was re-categorized to ≥GG2 on biopsy within 6 months of the diagnostic biopsy was excluded. Clinical variables including age, race, PSA and family history of PCa were documented. A positive mpMRI was defined as PIRAD≥3. The predictive value of phiD and mpMRI on disease re-categorization was assessed using both univariate and multivariable logistic regression in SAS 9.4 (Cary, NC). RESULTS: 418 men were included of which 57 (13.6%) were re-categorized to ≥GG2 on surveillance biopsies. There were no differences in the distribution of race, family history, and age between those who were re-categorized and those who remained GG1. However, the disease re-categorization group exhibited significantly more positive mpMRI (p=0.0001) and had higher PSA values (p=0.006), phi score values (p<.0001), and phiD values(p<.0001) (Table). In univariate analyses, phiD yielded the highest predictive value of disease re-categorization (AUC=0.79), followed by phi score (AUC=0.78), mpMRI (AUC=0.66) and PSA (AUC=0.65). Multivariable analysis demonstrated that phiD (OR=2.75, 95%CI 1.82-4.14) and mpMRI (OR=2.60, 95%CI 1.21-5.58) remained significant predictors (combined AUC=0.82). CONCLUSIONS: phiD is more predictive of disease re-categorization than mpMRI in men being followed by AS. As such, phiD should be strongly considered as part of algorithms to identify men who are at risk of disease re-categorization in AS.Source of Funding: None.

18F-PSMA-1007 multiparametric, dynamic PET/CT in biochemical relapse and progression of prostate cancer.

Aim of the present analysis is to investigate the biodistribution and pharmacokinetics of the recently clinically introduced radioligand 18F-PSMA-1007 in patients with biochemical recurrence or progression of prostate cancer (PC) by means of multiparametric (dynamic and whole-body) PET/CT. Twenty-five (25) patients with PC biochemical relapse or progression (median age = 66.0years) were enrolled in the analysis. The median PSA value was 1.2ng/mL (range = 0.1-237.3ng/mL) and the median Gleason score was 7 (range = 6-10). All patients underwent dynamic PET/CT (dPET/CT) scanning (60min) of the pelvis and lower abdomen as well as whole-body PET/CT with 18F-PSMA-1007. PET/CT assessment was based on qualitative evaluation, SUV calculation, and quantitative analysis based on a two-tissue compartment model and fractal analysis. 15/25 patients were PET-positive. Plasma PSA values in the 18F-PSMA-1007 positive group were higher (median = 3.6ng/mL; range = 0.2-237.3ng/mL) than in the 18F-PSMA-1007 negative group (median value = 0.7ng/mL; range = 0.1-3.0ng/mL). Semi-quantitative analysis in the PC lesions demonstrated a mean SUVaverage = 25.1 (median = 15.4; range = 3.5-119.2) and a mean SUVmax = 41.5 (median = 25.7; range = 3.8-213.2). Time-activity curves derived from dPET/CT revealed an increasing tracer accumulation during the 60min of dynamic PET acquisition into the PC lesions, higher than in the urinary bladder and the colon. Significant correlations were observed between 18F-PSMA-1007 uptake (SUV), influx, and fractal dimension (FD). 18F-PSMA-1007 PET/CT could detect PC lesions in 60% of the patients of a mixed population, including also patients with very low PSA values. Higher PSA values were associated with a higher detection rate. Dynamic PET analysis revealed an increasing tracer uptake during the dynamic PET acquisition as well as high binding and internalization of the radiofluorinated PSMA ligand in the PC lesions.

Prostate-specific antigen (PSA) and distress: - a cross-sectional nationwide survey in men with prostate cancer in Sweden

BackgroundThe prostate-specific antigen (PSA) -value is often used during the prostate cancer trajectory as a marker of progression or response to treatment. Concerns about PSA-values are often expressed by patients in clinical situations. Today there is a lack of larger studies that have investigated the association between PSA-value and distress. The aim was to investigate the association between PSA-values and distress adjusted for sociodemographic factors, hormonal therapy and quality of life (QoL), among men with prostate cancer.MethodsIn this cross-sectional survey of 3165 men with prostate cancer, members of the Swedish Prostate Cancer Federation, answered questions about sociodemographic factors, PSA, distress, QoL and treatments. Descriptive statistics, and bivariate and multivariable analyses were performed. The result was presented based on four PSA-value groups: 0–19, 20–99, 100–999, and ≥ 1000 ng/ml.ResultsOf the men, 53% experienced distress. An association between distress and PSA-values was found where higher PSA-values were associated with higher OR:s for experiencing distress in the different PSA-groups: 0–19 ng/ml (ref 1), 20–99 ng/ml (OR 1.25, 95% CI 1.01–1.55), 100–999 ng/ml (OR 1.47, 95% CI 1.12–1.94), ≥1000 ng/ml (OR 1.77, 95% CI 1.11–2.85). These associations were adjusted for sociodemographic factors and hormonal therapy. In the multivariable analyses, beside PSA-values, higher levels of distress were associated with being without partner or hormonal therapy. When adding QoL in the multivariable analysis, the association between PSA and distress did not remain significant.ConclusionThese results indicate that the PSA-values are associated with distress, especially for those with higher values. However, to be able to support these men, continued research is needed to gain more knowledge about the mechanisms behind the association between emotional distress and PSA-values.