Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial).

Purpose: The optimal treatment for patients with low to early-intermediate risk prostate cancer (PCa) remains to be defined. The randomized PREFERE trial (DRKS00004405) aimed to assess noninferiority of active surveillance (AS), external-beam radiotherapy (EBRT), or brachytherapy by permanent seed implantation (PSI) vs. radical prostatectomy (RP) for these patients.

Termination rates and histological reclassification of active surveillance patients with low- and early intermediate-risk prostate cancer: results of the PREFERE trial.

Purpose: Active surveillance (AS) strategies for patients with low- and early intermediate-risk prostate cancer are still not consistently defined. Within a controlled randomized trial, active surveillance was compared to other treatment options for patients with prostate cancer. Aim of this analysis was to report on termination rates of patients treated with AS including different grade groups.

[PREFERE - Study on the rise].

The PREFERE study, which compares the treatment options for prostate cancer with low and early intermediate risk, has recorded a noticeable upswing in recruitment since mid-2015. Responsible for this are the revised inclusion criteria and the wide support for this study in Germany. The inclusion criteria opened the study to the use of imaging techniques (MRI, C‑Trus / Anna) and the inclusion of all Gleason 3 + 3 = 6 cancers, regardless of tumor extent.

[The importance of pathology in the German prostate cancer study PREFERE].

Prostate cancer is the most common carcinoma of elderly males and holds the third place in the ranking of cancer-specific mortality. However, total mortality rate of 3 % is low and half of the patients die from other diseases, which is for the most part due to significantly improved diagnostic methods and the increasing use of prostate-specific antigen (PSA) screening. This has led to a stage migration towards early tumor stages that are prognostically heterogeneous and require differentiated treatment.

[PREFERE - the German prostatic cancer study: questions and claims surrounding study initiation in January 2013].

The PREFERE study is a multicenter randomized study of patients with low or early intermediate risk for prostatic cancer. The four treatment options, radical prostatectomy, percutaneous irradiation therapy, permanent seed implantation and active surveillance recommended by the German S3 guidelines and international guidelines will be tested and compared with respect to effectiveness and potential side effects. Over a period of 4 years a total of 7,600 patients are to be recruited and assigned to 1 of these 4 therapy forms according to personal preference (by possible exclusion of 1 or 2 therapy options) in a 2-4 arm study design by randomization.

[Localised prostate cancer: the PREFERE trial].

Prostate cancer is the most common carcinoma of the elderly man and holds the third place in the ranking of cancer-specific mortality. However, mortality rates of 3 % are low, and half of the patients will die from intercurrent disease. Due to the significantly improved diagnostic methods and the increasing use of PSA screening, there has been a stage migration towards early tumour stages that are prognostically heterogeneous and require differentiated treatment.

[Clinical studies outside university clinics : What are the problems to implement this?].

The demand for high quality evidence-based surgical treatment in Germany and awareness of the poor quality of surgical trials highlight the basic necessity of randomized controlled trials. In six surgical trial centers a professional infrastructure for surgical trials is in the process of being established since 2006.The aim is the initiation of surgical multicenter trials which can be effectively conducted by local networking.

RPLND or primary chemotherapy in clinical stage IIA/B nonseminomatous germ cell tumors? Results of a prospective multicenter trial including quality of life assessment.

Background: In order to reduce therapy-related morbidity in patients with nonseminomatous testicular germ cell tumors in clinical stage IIA/B, we performed a prospective multicenter trial comparing the standard retroperitoneal lymph node dissection (RPLND) +2 cycles of chemotherapy (arm A) with 3-4 cycles of primary chemotherapy (arm B).

Methods: From February 1991 to July 1995, 57 participating centers from Germany and Austria recruited 187 evaluable patients. 109 received primary RPLND and 78 primary chemotherapy.

Second malignancies following pure seminoma.

Purpose: Second malignancies in patients with pure testicular seminoma were studied in order to look for adverse late effects of treatment and to study the significance of second malignancies during follow-up.

Patients, Methods: In a multicentric investigation, 839 consecutive patients with pure testicular seminoma were observed for a median follow-up of 3.9 years.

Prognostic factors in seminomas with special respect to HCG: results of a prospective multicenter study. Seminoma Study Group.

Objective: In a prospective multicenter trial, it was our intention to elucidate clinical prognostic factors of seminomas with special reference to the importance of human chorionic gonadotropin (HCG) elevations in histologically pure seminomas.

Methods: Together with 96 participating urological departments in Germany, Austria, and Switzerland, we recruited 803 seminoma patients between 1986 and 1991. Out of 726 evaluable cases, 378 had elevated, while 348 had normal HCG values in the cubital vein.

The value of tumor markers in testicular seminomas. Results of a prospective multicenter study.

Objectives: In the course of a prospective multicenter trial, the value of tumor markers in seminomas was assessed.

Methods: Human chorionic gonadotropin (HCG), lactate dehydrogenase (LDH) and placental alkaline phosphatase (PlAP) were determined before and after orchidectomy and in the follow-up. Patients with elevated alpha-fetoprotein were considered to have nonseminomas.

Elevated human chorionic gonadotropin concentrations in the testicular vein and in peripheral venous blood in seminoma patients. An analysis of various parameters.

Objective: Human chorionic gonadotropin (HCG) elevations in the testicular vein (TV) are correlated with those in the cubital vein (CV). Their significance was tested regarding various prognostic parameters.

Method: Within the framework of a large multicentre study to assess the prognosis of HCG-positive seminomas 726 eligible patients were recruited from 1986 to 1991.

Deoxyribonucleic acid ploidy in seminomas with and without syncytiotrophoblastic cells.

Seminomas with human chorionic gonadotropin-producing syncytiotrophoblastic cells have been discussed as a distinctive subgroup with a worse prognosis. In a series of 50 seminomas (30 with immunohistochemically detectable syncytiotrophoblastic cells and 20 without syncytiotrophoblastic cells) deoxyribonucleic acid (DNA) ploidy was determined by flow cytometry in paraffin-embedded histopathological material. Comparatively, in 28 cases the DNA content was assessed by image cytometry on Feulgen-stained slides.

Size and status of metastases after inductive chemotherapy of germ-cell tumors. Indication for salvage operation.

Secondary resection of metastases remaining after inductive chemotherapy of advanced germ-cell tumors has thus far been obligatory. The absence of malignant components in one-third of all residual tumors and the high risk of the operation have led several authors to reconsider the criteria for this approach. In a retrospective study of 153 cases (127 evaluable) we investigated the histology of the primary tumor and the size of the residual tumor with regard to residual histology and outcome.

Retroperitoneal lymph node staging of testicular tumours. TNM Study Group.

A prospective multicentre study was carried out to determine the efficiency of various diagnostic methods in the assessment of the retroperitoneal space. The diagnostic findings were confirmed histologically after retroperitoneal lymph node dissection (RLND). The sensitivity was 71% for bipedal lymphography, 41% for computed tomography (CT), 31% for abdominal ultrasound and 37% for alpha-fetoprotein/human chorionic gonadotrophin (AFP/HCG).

[The "false positive" tumor marker in malignant testicular tumor].

In addition to the histological diagnosis, alpha fetoprotein (AFP) and chorion gonadotropin (HCG) are used in clinical staging, therapy monitoring, and follow-up. Elevated markers without localization of metastases by imaging procedures are generally classified as progressive disease. However, other causes may be responsible for the elevated tumor markers: other malignant or benign diseases such as hepatocellular carcinomas, gastrointestinal tumors, bronchial carcinomas and benign diseases of the liver for AFP, and vesicular mole, hepatocellular, stomach, pancreatic and urothelial carcinomas for HCG.

[Therapy of non-seminomatous testicular tumor stage II A/B (pT+N1/2Mo)].

In these stages standard therapy (RLND + 2 courses PEB) reveals survival rates of more than 95%. The high rates of toxic side effects from two aggressive treatment strategies induce considerations about reducing therapy. We may be able to omit one of the therapeutic methods: (a) RLND alone can cure half of the patients; the others could have chemotherapy if progression is found.