A cost outcome study of varicocoele embolisation and future pregnancy in an Australian public hospital setting.

INTRODUCTION: Varicocoele is commonly encountered in males with infertility. Studies have shown that varicocoele repair (surgery or embolisation) can improve the rate of subsequent pregnancy. In Australia, there have been no studies assessing the cost of varicocoele embolisation and current practice is based on international data. This study aimed to assess the cost of varicocoele embolisation and estimate the treatment cost per pregnancy. METHODS: Retrospective cost-outcome study of patients treated by embolisation between January 2018 and 2023. A bottom-up approach was used to calculate procedure costs whereas a top-down approach was used to calculate costs for all other patient services, including direct and indirect costs. To calculate cost per pregnancy, costs were adjusted according to existing published data on the rate of pregnancy after embolisation. RESULTS: Costing data from 18 patients were included, of median age 33.5 years (range 26-60) and median varicocoele grade 2.5 (range 1-3). All patients had unilateral treatment, most commonly via right internal jugular (16 patients, 89%) and using a 0.035″ system (17 patients, 94%). The median cost for the entire treatment including procedural, non-procedural, ward and peri-procedural costs was AUD$2208.10 (USD$1405 or EUR€1314), range AUD$1691-7051. The projected cost to the healthcare system per pregnancy was AUD$5387 (USD$3429 or EUR€3207). CONCLUSION: Total varicocoele embolisation cost and the cost per-pregnancy were lower than for both embolisation and surgical repair in existing international studies. Patients undergoing varicocoele treatment should have the option to access an interventional radiologist to realise the benefits of this low-cost pinhole procedure.

Role of CT angiography and therapeutic anticoagulation in patients presenting to the emergency department with acute gastrointestinal bleeding.

INTRODUCTION: Acute gastrointestinal bleeding (GIB) is associated with morbidity and mortality. There can be a low threshold for practitioners to assess for active GIB and computed tomography angiography (CTA) examinations are performed frequently, even for stable patients and those who are therapeutically anticoagulated. We aimed to assess the predictive value of CTA for acute GIB and the influence of CTA on treatment. METHODS: Retrospective single-centre study over a 2-year period. RESULTS: A total of 227 patients with mean age 67.7 years (SD 17.86), 58.6% male. 84.4% were for lower GIB. 49 patients were on therapeutic anticoagulation (21.6%). 45 CTAs were positive (19.8%). 22 patients received embolisation, and 15 received acute endoscopic treatment. CTA sensitivity was 68.6% and specificity 89.1%. The PPV was 53.3% and NPV 93.9%. The odds ratio of a positive CTA requiring treatment for patients on therapeutic anticoagulation was 1.1 (P = 0.932) compared with the odds of patients not taking therapeutic anticoagulation 21.5 (P < 0.001). The risk ratio for requiring treatment if not taking anticoagulation was 6.2. A total of 19 patients (9.1%) met the definition of CI-AKI as a result of the CTA. A pre-existing eGFR of less than 20 was associated with significantly increased odds of developing CI-AKI (OR 3.95, P = 0.031, 95%CI 1.135-13.782). CONCLUSIONS: The presence of anticoagulation has a significant impact on the decision not to perform interventional treatments on patients with acute GIB when CTA is positive. Anticoagulant reversal and volume resuscitation are important front-line measures, and CTA may have a role for those anticoagulated who are haemodynamically unstable after resuscitation.

The Detection of Prostate Cancer with Magnetic Resonance Imaging-Targeted Prostate Biopsies is Superior with the Transperineal vs the Transrectal Approach. A European Association of Urology-Young Academic Urologists Prostate Cancer Working Group Multi-Institutional Study.

PURPOSE: Our aim was to evaluate whether transperineal (TP) MRI-targeted prostate biopsy (TBx) may improve the detection of clinically significant prostate cancer (csPCa), defined as International Society of Urological Pathology ≥2, in comparison to transrectal (TR) TBx. MATERIALS AND METHODS: A multicenter retrospective cohort study comprising patients who underwent MRI-guided prostate biopsy was conducted. To address possible benefits of TP-TBx in the detection of prostate cancer (PCa) and csPCa, a cohort of patients undergoing TP-TBx were compared to patients undergoing TR-TBx. Multivariable logistic regression analyses were performed to assess predictors of PCa and csPCa detection. RESULTS: Overall, 1,936 and 3,305 patients who underwent TR-TBx vs TP-TBx at 10 referral centers were enrolled. The rate of PCa and csPCa diagnosed was higher for TP-TBx vs TR-TBx (64.0% vs 50%, p <0.01 and 49% vs 35%, p <0.01). At multivariable analysis adjusted for age, biopsy naïve/repeated biopsy, cT stage, Prostate Imaging-Reporting and Data System®, prostate volume, PSA, and number of biopsy cores targeted, TP-TBx was an independent predictor of PCa (odds ratio [OR] 1.37, 95% CI 1.08-1.72) and csPCa (1.19, 95% CI 1.12-1.50). When considering the approach according to the site of the index lesion, TP-TBx had a significantly higher likelihood than TR-TBx to detect csPCa in the apex (OR 4.81, 95% CI 1.03-6.27), transition/central zone (OR 2.67, 95% CI 1.42-5.00), and anterior zone (OR 5.62, 95% CI 1.74-8.13). CONCLUSIONS: The use of TP-TBx allows a better cancer grade definition and PCa risk assessment. This has important implication in the decision-making process and in patient counseling for further therapies.

Event-free survival after radical prostatectomy according to prostate-specific membrane antigen-positron emission tomography and European Association of Urology biochemical recurrence risk groups.

OBJECTIVE: To assess European Association of Urology (EAU) risk groups for biochemical recurrence (BCR) of prostate cancer relative to prostate-specific membrane antigen-positron emission tomography (PSMA-PET) status and oncological outcomes. PATIENTS AND METHODS: A retrospective analysis of a study that incorporated PSMA-PET for men with BCR after radical prostatectomy (RP) was undertaken. EAU risk groups were considered relative to clinical variables, PSMA-PET findings, and deployment of salvage radiotherapy (SRT). The primary oncological outcome was event-free survival (EFS) and this was analysed relative to clinical and imaging variables. An 'event' occurred if prostate-specific antigen (PSA) level rose >0.2 ng/mL above nadir or additional therapies were introduced. RESULTS: A total of 137 patients were included, most of whom had EAU high-risk disease (76%) and/or low PSA levels (80% <0.5 ng/mL) at the time of PSMA-PET. EAU risk group was not associated with regional nodal/distant metastasis on PSMA-PET. Regional nodal/distant metastasis on PSMA PET (compared to negative/local recurrence: hazard ratio [HR] 2.2; P = 0.002) and SRT use (vs no SRT: HR 0.44; P = 0.004) were associated with EFS. EAU high-risk status was not significantly associated with worse EFS (HR 1.7, P = 0.12) compared to EAU low-risk status. Among patients who received SRT, both regional/distant metastasis on PSMA-PET (HR 3.1; P < 0.001) and EAU high-risk status (HR 2.9; P = 0.04) were independently associated with worse EFS, which was driven by patients in the EAU high-risk group with regional/distant metastases (38%; HR 3.1, P = 0.001). CONCLUSIONS: In patients with post-RP BCR, PSMA-PET findings and receipt of SRT predicted EFS. In patients receiving SRT, PSMA status combined with EAU risk grouping was most predictive of EFS. These findings suggest that the EAU risk groups could be improved with the addition of PSMA-PET.

Diagnostic value of 68 Ga-DOTATATE PET-CT imaging for staging of ER+ /PR+ HER2- breast cancer patients with metastatic disease: Comparison with conventional imaging with bone scan, diagnostic CT and 18 F-FDG PET-CT in a prospective pilot trial.

INTRODUCTION: 18 F-Fludeoxyglucose PET-CT (FDG) is increasingly used to stage breast cancer. Most breast cancers express the Oestrogen Receptor (ER) and Progesterone Receptor (PR), and this subtype demonstrates lower activity on FDG imaging. Somatostatin receptors (SSTR) offer a potentially improved radiotracer target for ER+ /PR+ breast cancer. We present the first in vivo clinical study comparing 68 Ga-DOTATATE PET-CT (DOTA) to FDG and conventional imaging (bone scan and diagnostic CT), in metastatic ER+ /PR+ human epidermal growth factor receptor 2 (HER2) negative breast cancer. METHODS: Patients with clinically progressive metastatic ER+ /PR+ HER2- breast cancer underwent restaging with DOTA, FDG and conventional imaging. Scans were analysed visually, and semi-quantitatively. Wilcoxon-Rank Scoring was used to assess significance. RESULTS: Ten women (mean age 57 years) underwent imaging. 8/10 demonstrated disease on both DOTA and FDG. 2/10 positive on conventional imaging, but DOTA- /FDG- , and had no disease progression at 1-year follow-up. Heterogeneity of uptake was seen between DOTA and FDG with 5 bone lesions DOTA+ /FDG- and 1 bone lesion FDG+ /DOTA- . Twenty-one visceral lesions were FDG+ /DOTA- (2 patients), with 10/21 identified on conventional imaging. Maximum standard uptake values (SUV max) of DOTA were greater than FDG (10.9 vs. 6.6, P = ns). Four sites were biopsied (3 patients). 3/4 had high ER/PR expression (mean DOTA SUV max 9.4) and 1/4 low ER/PR expression (DOTA SUV max 3.1). CONCLUSION: Whilst we have not demonstrated DOTA to be superior to FDG in staging of ER+ /PR+ breast cancers, DOTA may have a role in assessing HR status and treatment decisions; further evaluation of this is warranted.

Distribution of prostate cancer recurrences on gallium-68 prostate-specific membrane antigen (68 Ga-PSMA) positron-emission/computed tomography after radical prostatectomy with pathological node-positive extended lymph node dissection.

OBJECTIVES: To examine the anatomical distribution of prostate cancer (PCa) recurrence on gallium-68 prostate-specific membrane antigen (68 Ga-PSMA) positron-emission tomography (PET)/computed tomography (CT) in patients with biochemical recurrence (BCR) after undergoing radical prostatectomy (RP) with pathological lymph node metastasis (pN1) in their extended pelvic lymph node dissection (ePLND), and to compare the location of PCa recurrence with the location of the initial lymph node metastasis at ePLND. MATERIALS AND METHODS: We retrospectively reviewed 100 patients with BCR (PSA 0.05-5.00 ng/mL) after RP with pN1 ePLND who underwent 68 Ga-PSMA PET/CT to guide salvage therapy. Clinical and pathological features and anatomical locations of PCa recurrence on 68 Ga-PSMA PET/CT were obtained, and management impact was recorded. RESULTS: In all, 68 patients (68%) had a positive and 32 patients (32%) had a negative 68 Ga-PSMA PET/CT result. Of the 68 patients with a positive 68 Ga-PSMA PET/CT, 44 (65%) showed abnormal uptake only in the pelvic area, seven (10%) only outside the pelvic area, and 17 (25%) both within and outside the pelvic area. 68 Ga-PSMA PET/CT-positive pelvic lymph nodes were often (84%) detected on the same side as the lymph node metastasis diagnosed at ePLND. Based on the outcomes of the 68 Ga-PSMA PET/CT, change of management was noted in 68% of the patients. CONCLUSION: Recurrence of PCa on 68 Ga-PSMA PET/CT was limited to the pelvis in the majority of patients with BCR after RP with pN1 ePLND. Moreover, recurrence was often detected on the same side as the lymph node metastasis at ePLND. The results confirm the diagnostic value of 68 Ga-PSMA PET/CT in patients with BCR after RP with pN1 ePLND. Prospective studies are needed to support the long-term benefit of 68 Ga-PSMA PET/CT-dictated management changes.

3-Year Freedom from Progression After 68Ga-PSMA PET/CT-Triaged Management in Men with Biochemical Recurrence After Radical Prostatectomy: Results of a Prospective Multicenter Trial.

68Ga-labeled prostate-specific membrane antigen (PSMA) PET/CT is increasingly used in men with biochemical recurrence (BCR) after radical prostatectomy (RP), but its longer-term prognostic or predictive potential in these men is unknown. The aim of this study was to evaluate the predictive value of PSMA PET for a 3-y freedom from progression (FFP) in men with BCR after RP undergoing salvage radiotherapy (sRT). Methods: This prospective multicenter study enrolled 260 men between 2015 and 2017. Eligible patients were referred for PSMA PET with a rising level of prostate-specific antigen (PSA) after RP. Management after PSMA PET was recorded but not mandated. PSMA PET protocols were standardized across sites and reported prospectively. Clinical, pathologic, and surgical information; sRT; timing and duration of androgen deprivation; 3-y PSA results; and clinical events were documented. FFP was defined as a PSA rise of no more than 0.2 ng/mL above nadir after sRT, with no additional treatment. Results: The median PSA was 0.26 ng/mL (interquartile range, 0.15-0.59 ng/mL), and follow-up was 38 mo (interquartile range, 31-43 mo). PSMA PET had negative results in 34.6% (90/260), showed disease confined to the prostatic fossa in 21.5% (56/260), showed disease in the pelvic nodes in 26.2% (68/260), and showed distant disease in 17.7% (46/260). Of the patients, 71.5% (186/260) received sRT: 38.2% (71/186) to the fossa only, 49.4% (92/186) to the fossa plus the pelvic nodes, and 12.4% (23/186) to the nodes alone or stereotactic body radiation therapy. PSMA PET was highly predictive of FFP at 3 y after sRT. Overall, FFP was achieved in 64.5% (120/186) of those who received sRT, 81% (81/100) with negative results or fossa-confined findings versus 45% (39/86) with extrafossa disease (P < 0.0001). On logistic regression, PSMA PET was more independently predictive of FFP than established clinical predictors, including PSA, T stage, surgical margin status, or Gleason score (P < 0.002). Thirty-two percent of men with a negative PSMA PET result did not receive treatment. Of these, 66% (19/29) progressed, with a mean rise in PSA of 1.59 ng/mL over the 3 y. Conclusion: PSMA PET results are highly predictive of FFP at 3 y in men undergoing sRT for BCR after RP. In particular, men with negative PSMA PET results or disease identified as still confined to the prostatic fossa demonstrate high FFP, despite receiving less extensive radiotherapy and lower rates of additional androgen deprivation therapy than those with extrafossa disease.

Gallium-68-prostate-specific membrane antigen (68 Ga-PSMA) positron emission tomography (PET)/computed tomography (CT) predicts complete biochemical response from radical prostatectomy and lymph node dissection in intermediate- and high-risk prostate cancer.

OBJECTIVE: To determine the value of gallium-68-prostate-specific membrane antigen (68 Ga-PSMA)-11 positron emission tomography (PET) /computed tomography (CT) in men with newly diagnosed prostate cancer. PATIENTS AND METHODS: We analysed results of 140 men with intermediate- and high-risk prostate cancer. All men underwent 68 Ga-PSMA-11 PET/CT and multiparametric magnetic resonance imaging (mpMRI) before radical prostatectomy (RP) with extended pelvic lymph node (LN) dissection. For each patient, the clinical and pathological features were recorded. Prostate-specific antigen (PSA) was documented at staging scan, and after RP, at a median (interquartile range) of 110 (49-132) days. A PSA level of ≥0.03 ng/mL was classified as biochemical persistence (BCP). Logistic regression was performed for association of clinical variables and BCP. RESULTS: In these 140 patients with intermediate- and high-risk prostate cancer, 27.1% had PSMA PET/CT-positive findings in the pelvic LNs. Sensitivity and specificity for detection of LN metastases were 53% and 88% (PSMA PET/CT) and 14% and 99% (mpMRI), respectively. The overall BCP rate was 25.7%. The BCP rate was 16.7% in men who were PSMA PET/CT LN-negative compared to 50% in men who were PSMA PET/CT LN-positive (P < 0.05). The presence of PSMA-positive pelvic LNs was more predictive of BCP after RP than cT-stage, PSA level, and the Gleason score, adjusted for surgical margins status. CONCLUSIONS: 68 Ga-PSMA-11 PET/CT is highly predictive of BCP after RP, and should play an important role informing men with intermediate- or high-risk prostate cancer.

68Ga-HBEDD PSMA-11 PET/CT staging prior to radical prostatectomy in prostate cancer patients: Diagnostic and predictive value for the biochemical response to surgery.

METHODS:: We analysed results of 142 males with staging PSMA prior to radical prostatectomy (RP). Data collected included PSMA PET/CT, bone scan (30/142), mpMRI (112/142), and pathological T stage (pT) stage, Gleason score, surgical margins and lymph node status at RP. Prostate-specific antigen (PSA) was documented at staging scan, and following surgery (median 45 days (interquartile range 38-59). A PSA of < 0.03 ng ml-1 was classified as surgical response (SR). Logistic regression was performed for association of pre-operative clinical variables and SR. RESULTS:: 97.9% (139/142) of males had positive intraprostatic findings on PSMA. 14.1 % (20/142) of males had further sites of extra prostatic disease identified on PSMA PET. In males with disease confined to the prostate, 82.9 % (92/111) achieved an SR, compared to 28.6 % (4/14) in males with extraprostatic disease identified (lymph node positive and distant metastatic disease) (p < 0.001). On binary logistic regression PSMA had a superior predictive value for SR than Gleason score, PSA (at time of imaging) or pT stage. MRI was less sensitive and more specific for SVI, and less sensitive for nodal involvement. CONCLUSION:: Extraprostatic disease identified on staging pre-operative PSMA PET is independently predictive of a poor surgical response to RP, and may indicate a need for a multimodality approach to treatment. ADVANCES IN KNOWLEDGE:: This is one of the first studies to correlate the PSMA PET's staging capacity to prostate cancer patient's outcomes to radical prostatectomy and indicates it's potential in predicting which patients will benefit from radical prostatectomy.

Treatment Outcomes from 68Ga-PSMA PET/CT-Informed Salvage Radiation Treatment in Men with Rising PSA After Radical Prostatectomy: Prognostic Value of a Negative PSMA PET.

68Ga-PSMA (prostate-specific membrane antigen) PET/CT is increasingly used in men with prostate-specific antigen (PSA) failure after radical prostatectomy (RP) to triage those who will benefit from salvage radiation treatment (SRT). This study examines the value of PSMA-informed SRT in improving treatment outcomes in the context of biochemical failure after RP. Methods: We analyzed men with rising PSA after RP with PSA readings between 0.05 and 1.0 ng/mL, considered eligible for SRT at the time of PSMA. For each patient, clinical and pathologic features as well as scan results, including site of PSMA-positive disease, number of lesions, and a certainty score, were documented. Subsequent management, including SRT, and most recent PSA were recorded using medical records. Treatment response was defined as both PSA ≤ 0.1 ng/mL and >50% reduction in PSA. Multivariate logistic regression analysis was performed for association of clinical variables and treatment response to SRT. Results: One hundred sixty-four men were included. PSMA was positive in 62% (n = 102/164): 38 of 102 in the prostatic fossa, 41 of 102 in pelvic nodes, and 23 of 102 distantly. Twenty-four patients received androgen-deprivation therapy (ADT) and were excluded for outcomes analysis. In total, 99 of 146 received SRT with a median follow-up after radiation treatment of 10.5 mo (interquartile range, 6-14 mo). Overall treatment response after SRT was 72% (n = 71/99). Forty-five percent (n = 27/60) of patients with a negative PSMA underwent SRT whereas 55% (33/60) did not. In men with a negative PSMA who received SRT, 85% (n = 23/27) demonstrated a treatment response, compared with a further PSA increase in 65% (22/34) in those not treated. In 36 of 99 patients with disease confined to the prostate fossa on PSMA, 81% (n = 29/36) responded to SRT. In total, 26 of 99 men had nodal disease on PSMA, of whom 61% (n = 16/26) had treatment response after SRT. On multivariate logistic regression analysis, PSMA and serum PSA significantly correlated with treatment response, whereas pT stage, Gleason score, and surgical margin status did not. Conclusion: PSMA PET is independently predictive of treatment response to SRT and stratifies men into a high treatment response to SRT (negative or fossa-confined PSMA) versus men with poor response to SRT (nodes or distant-disease PSMA). In particular, a negative PSMA PET result predicts a high response to salvage fossa radiotherapy.