Interim analysis of the prospective COTRIMS (Cologne Trial of Retroperitoneal Lymphadectomy in Metastatic Seminoma) trial.

409 Background: Radiation therapy or systemic chemotherapy with 3 cycles PEB represent the guideline recommended treatment options in marker negative clinical stage IIA/B seminoma. Despite a high cure rate of 90% to 94% and 82% to 90% in CS IIA and IIB, respectively, both therapeutic options are associated with significant long-term toxicities. It was the aim of our trial to evaluate the feasibility, oncological efficacy and treatment associated morbidity of primary nsRPLND in stage IIA/B seminoma. Methods: 30 patients with marker negative clinical stage IIA and IIB classical seminoma of the testis were recruited in the prospective trial. Primary goal was a relapse rate &lt;20% within 2 years follow-up. Exclusion criteria were adjuvant carboplatin therapy for clinical stage I disease, extensive clinical stage IIb or clinical stage IIC disease, previous retroperitoneal surgery or radiation therapy, and positive tumor markers. All patients underwent nerve sparing RPLND with a modified template resection. None of the patients received adjuvant chemotherapy in the presence of positive lymph nodes. All patients underwent close follow-up with imaging studies and tumor markers at 3-month intervals during the first 2 years, at 6-month intervals in year 3 and annually thereafter. 10 pts had preoperative serum analysis of miR371. Results: Mean age was 34.2 (21-54) years. Mean follow-up is 29.4 (1-60) months and 32.5 (3-60) for those with a minimum follow-up of 3 months. All patients were treatment-naïve; 19 and 11 patients were diagnosed with stage IIA and IIB disease, respectively, at time of RPLND. 28 and 2 patients underwent open and robot assisted ns RPLND, respectively. Mean OR time was 131 (105-195) min, mean blood loss was &lt; 150ml and the mean hospitalization time was 4.5 (3-9) days. We did not observe surgery associated complications &gt; Clavien Dindo grade 3a. Mean number of dissected lymph nodes was 18 (7-57), the mean number of positive lymph nodes was 1.3 (1-2) and the mean diameter of positive nodes was 2.3 (0.8-4.1) cm. Histology of the resected lymph nodes revealed metastatic seminoma in 25 (80%) patients; 2 and 3 patients demonstrated embryonal carcinoma and benign disease, resp. 10 pts underwent serum analysis of miR371 preoperatively which predicted metastatic disease in 9/10 and benign histology in 1/1. 2/30 (6.7%) patients developed an outfield relapse 4 and 6 months postoperatively. Both patients were salvaged by systemic chemotherapy with 4 cycles PEB. Conclusions: NsRPLND results in a high cure rate at midterm follow-up and it is associated with a low frequency of treatment associated morbidities making this approach a feasible alternative to standard radiation therapy or systemic chemotherapy. MiR371p might be a useful marker to predict presence/absence of metastases in equivocal findings. Clinical trial information: DRKS00025384 . </jats:p

Cytoreductive radical prostatectomy (cRP) in the management of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC).

161 Background: Although still discussed controversially, cRP represents a therapeutic option for mHSPC patients in the context of a multimodality approach. It was the purpose of our study to retrospectively review the oncological and functional outcome of a single-center cohort of cRP patients. Methods: A total of 134 mHSPC patients underwent cRP with pelvic lymphadenectomy. All patients received neoadjuvant androgen deprivation therapy (ADT, n = 34), ADT + docetaxel (n=15), or ADT plus ABI/ENZA/APA (n=85) for 6 months which was continued postop. Follow-up studies were performed at 3-month intervals, new imaging studies with 68Ga-PSMA PET/CT was done at PSA-levels &gt; 1.0 ng/ml. Perioperative complications were evaluated according to Clavien-Dindo classification. Clinical progression free survival (cPFS) and cancer specific survival (CSS) were calculated via Kaplan-Maier analysis. Multivariate regression analysis was used to assess the impact of biopsy ISUP grade, PSA at diagnosis and preop., PSA decrease, T stage, and metastatic burden on PFS and CSS. Results: 115 and 19 had low and high volume mHSPC, resp. Mean age was 64.2 (42-88) years, mean preop. PSA was 3.2 (0.1-21.6) ng/ml. The median Follow-up ist 53.7 (4 – 168) months. M1a, M1b and M1c were present in 28 (20.9%), 98 (73.1%) and 8 (6.0%) men. Pathohistology demonstrated pT0 in 3 (2.2%), pT2a-c in 21 (15.7%), pT3 and pT4 in 105 (78.3%) and 5 (3.7%). pN0 and pN+ was diagnosed in 38 (28.3%) and 96 (71.7%) pts. There was no significant difference between type of ADT and final pathohistology. Clavien-Dindo Grad 3a-b and 4 complications were observed in 13 (9.7%) and 2 (1.5%) pts. CSS was 88.1% and cPFS was 53%. None of the pts developed locally recurrent disease. Overall survival was reduced in M1 high volume (61.9% vs 92.8%, p=0.002) and pN+ (85.7% vs 96.7%, p=0.001). cT≥3b (HR=2.24, p=0.02) and M1 high volume (HR=2.35, p=0.01) were associated with reduced cPFS; M1 high volume (HR=1.49, p=0.03) and relative PSA decrease £60% (HR=1.37, p=0.03) were associated with reduced CSS. Conclusions: cRP can be performed with minimal morbidity. mHSPC patients with clinically localized high risk PCA, low metastatic burden and good response to nADT benefit most from this approach. The risk for symptomatic local relapse is low. Limitation of the study is its retrospective design. </jats:p

Testis-sparing surgery in adult patients with germ cell tumors: Systematic search of the literature and focused review

Testis-sparing surgery (TSS) is a guideline-recommended treatment option for men with synchronous or metachronous bilateral testicular germ-cell tumor (GCT) or GCT in a solitary testicle. The tumor volume should not exceed 50% of the total testicular volume and serum concentrations of both testosterone and luteinizing hormone should be within the normal ranges. After tumor enucleation, patients should undergo adjuvant radiation of the testicle in case of germ cell neoplasia in situ. The local relapse rate is approximately 4% if TSS is performed properly. Physiological serum testosterone concentrations are achieved in more than 85% of patients, and approximately 50% of men with intact spermatogenesis can achieve paternity. The risk of systemic metastases is not increased by TSS. Patient summary: Testis-sparing surgery is the treatment of choice for men with testicular cancer in both testes or in men who have just one testis. In more than 85% of patients this approach results in maintenance of normal testosterone levels

Evaluation of miRNA-371a-3p (miR371a) assay to predict final pathohistology in patients undergoing primary nerve-sparing retroperitoneal lymphadenectomy (nsRPLND) for stage IIA/B seminomas and non-seminomas.

427 Background: NS-RPLND represents a guideline recommended treatment option in marker negative low volume metastatic seminomas and nonseminomas (NSGCT). However, about 30% of clinical stage IIA patients demonstrate equivocal findings of uncertain dignity so that they might undergo unnecessary treatment. Elevated serum concentrations of the molecular marker miR371 have been reported to correlate with the clinical stage even in small volume metastases. It was the purpose of our pilot study to evaluate the predictive accuracy of miR371 in a cohort of patients who underwent nsRPLND for clinical stage IIA/B germ cell tumors of the testis. Methods: Between 1-9/2022, 16 patients with marker negative clinical stage IIA/B seminomas (n=10) and NSGCT (n=6) underwent primary nsRPLND with a modified template resection via an open surgical approach. Blood specimens (20ml) were drawn on the day immediately prior to surgery and processed according to the manufacturer’s protocol. miRNA is extracted and purified with the Maxwell RSC MiRNA Plasma and Serum Kits prior to its transcription into cDNA using cDNA Solution, Reverse Transcriptase and RNase Inhibitor. Subsequently, this cDNA is amplified. Using qPCR techniques, the miRNA 371a is quantified using Roche Lightcycler 480 II. Using the Lightcycler software, the median Cp (CP = crossing points) of the triplicates is calculated and converted into a RQ value (RQ= relative abundance). Results: nsRPND was performed in all patients without significant Clavien-Dindo IIIa-V complications. Mean OR time was 131 (105-195) minutes, mean blood loss was &lt; 150ml, transfusion rate was 0%. Mean number of dissected lymph nodes was 17 (7-32), mean diameter of positive lymph nodes was 2.1 (0.8-4.1) cm. Histology revealed metastatic seminoma or nonseminoma in 12/16 (75%). In 4 patients histology revealed non-malignant disease (n=2), teratoma, and lymphoma. miR371 was positive in all 12 (100%) pts with metastases and it was negative in 3/4 (75%) pts without metastases. One patient with small volume CS IIA seminoma was false negative. Conclusions: This is the first report to demonstrate that miR371can be used as a personalized and individual biomarker to predict the presence of small volume retroperitoneal lymph node metastases in CS IIA/B seminomas and in nonseminomas. Patients with positive findings should undergo active treatment whereas negative findings should result in close follow-up. Date are currently validated in a multi-institutional trial. </jats:p

Mapping European Association of Urology Guideline Practice Across Europe: An Audit of Androgen Deprivation Therapy Use Before Prostate Cancer Surgery in 6598 Cases in 187 Hospitals Across 31 European Countries

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