Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Prostatic Hyperplasia

Hyperplasia

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Inclusion criteria for the suspicion cohort include clinical suspicion for PCa and indication for PCA diagnostics based on any of the following: 1) elevated PSA (\>2.5 ng/ml), 2) palpable prostate tumor/nodule, 3) image finding suggestive of PCa.

The suspicion cohort will include a total of 300 subjects who will undergo PCa diagnostics including prostate MRI, and transrectal ultrasound (TRUS) guided prostate biopsies. After the diagnostic procedures all subjects are categorized to one of the following groups: 1) subject without PCa, 2) subject with clinically non-significant PCa (ISUP grade 1/Gleason 3+3), 3) clinically significant PCa (ISUP grade \>1/\>Gleason 3+3).

Based on the outcome of the PCa diagnostics and planned clinical treatment, subjects may be eligible to other cohorts as well.

Inclusion criteria for the cancer cohort include clinically significant prostate cancer planned to be treated with radical prostatectomy with or without pelvic lymph node dissection. The cancer cohort will include a total of 50 subjects.

Inclusion criteria for the benign (TURP) cohort includes benign prostate hyperplasia (BPH) planned to be treated with transurethral resection of the prostate (TURP). The benign/TURP-cohort will include a total of 50 subjects.

Inclusion criteria for the benign/cystectomy cohort includes bladder cancer planned to be treated with removal of the urinary bladder and prostate (cystoprostatectomy). The benign/cystectomy cohort will include a total of 25 subjects.

Prostate MRI scan is performed according to the protocol used in earlier studies (PMID 31158230). In addition to the PCa diagnostics, the scan will include abdominal imaging to body composition analysis (visceral and subcutaneous fat and psoas muscle). Baseline blood and urine samples are collected in Turku University Hospital laboratory.

MRI scan and laboratory visit

The visit follows routine outpatient clinic protocol. The results from MRI and laboratory findings are discussed and the potential benefits and harms from prostate biopsies are evaluated. After a mutual decision, prostate biopsies are performed.

Prostate biopsies

Baseline blood and urine samples are collected at the time of surgery. Robotic assisted laparoscopic prostatectomy (RALP) is performed according to routine protocol. Routine diagnostic histopathological procedures will be followed, and study tissue samples are obtained in the department of pathology.

Radical prostatectomy and blood, urine and tissue sampling

Baseline blood and urine samples are collected the time of surgery. TURP is performed according to normal protocol. Routine diagnostic histopathological procedures will be followed in the department of pathology. Additionally, tissue samples (a total of 10 resection chips) will be collected for study analyses. Due to the study, no additional tissue samples are removed, i.e. study samples are from the tissues removed as clinically indicated.

TURP and blood, urine and tissue sampling

Baseline blood and urine samples are collected at the time of surgery. Radical cystoprostatectomy is performed according to routine protocol. Routine diagnostic histopathological procedures will be followed, and study tissue samples are obtained in the department of pathology.

Radical cystoprostatectomy and blood, urine and tissue sampling

Peter J. Bostrom, MD, PhD

Tarja Lamminen, PhD

Peter J Bostrom, MD, PhD

Antti Salminen, MD

Peter J. Boström, MD, PhD

This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.

Prostate cancer (PCa) is a significant health care system challenge. PCa is the most common male cancer in Finland and most western countries. Interestingly, although the incidence of indolent (latent) PCa is very similar throughout the globe, there is a remarkable global age-adjusted incidence variation (up to 40-fold difference between highest and lowest incidences).

Epidemiological data suggest that aging in men is associated with neoplastic processes in the prostate but only a subset of men will develop a true malignancy potentially affecting their life-span or quality of life. Genetic factors have a significant effect on PCa risk, but very likely life-style (e.g. diet and physical activity) affect PCa risk as well, but the mechanisms mediating protective or harmful effects of life-style remain unclear.

Gut microbiota, i.e. the collection of microbes colonizing the gastrointestinal tract, has been acknowledged to play significant role in many metabolic pathways and pathogenetic processes in the human body. Although there is some evidence suggesting that gut microbiota affects therapy responses (especially androgen deprivation) in PCa, it´s potential role in prostate carcinogenesis is not well documented. Our previous studies suggest that gut microbiota composition is different in men with and without PCa potentially contributing to the Pca risk, and that changes in steroid hormone synthesis may be one mechanism how gut microbiota affects PCa risk.

PROMIC is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and PCa. The main aim is to validate our preliminary findings of association between gut microbiota and PCa. We also study metabolic characteristics in the gut, systemic circulation, and prostate tissue in men with different gut microbiota signatures. The study is carried out in Turku University Hospital and University of Turku.

1. Blood and urine samples: Serum, plasma and whole blood samples will be collected to measure steroid hormone concentrations, global analysis of molecular lipids and polar metabolites, and for DNA sequence analysis.
2. Stool samples:Stool samples will be collected and stored in OMNImetGUT and OMNIgeneGUT and eSwab tubes. Samples will be used for sequencing and for antimicrobial susceptibility testing.
3. Tissue samples: Fresh frozen tissue samples will be collected from subjects going to surgery (TURP, RALP, Cystoprostatectomy) for sequencing and mass spec analysis.

Prostate Metabolism, Cancer Risk and Gut Microbiota

Metabolic characteristics in the systemic circulation in men with different gut microbiota signatures

Metabolic characteristics in the prostate tissue in men with different gut microbiota signatures

Gut microbiota signature in men with clinically significant prostate cancer, clinically non-significant prostate cancer, and benign prostate histology

Metabolic characteristics in the gut in men with different gut microbiota signatures

University of Turku

Turku University Hospital

Digestive System Diseases

Gastroesophageal Reflux

Urinary Bladder Neoplasms

Postoperative Complications

Urologic Neoplasms

Urogenital Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

i-gel

C-LMA

Reyhan Polat, MD

Murat Alper, Prof.

1. i-gel
2. C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.

120 ASA I-II adult patients. Patients were randomised into two groups

1. i-gel
2. C-LMA Volume controlled ventilation, general anesthesia Asses Gastroeosephageal reflux, sore throat, coughing, dysphagia,dysphonia recorded.

Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications

Comparation the Effect of C-LMA and I-gel in Regurgitation and Postoperative Complications

the airway device will be examined for a precence of blue dye

The ph of the secretions on the airway device will be measurd with a Ph-meter

The airway device will be examined with fiberoptic endoscope after placement

Diskapi Yildirim Beyazit Education and Research Hospital

Doctor

Behaviors and Mental Disorders

Diseases and Abnormalities at or Before Birth

Erectile Dysfunction

Congenital Abnormalities

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Genital Neoplasms, Male

Urological Agents

All Drugs and Chemicals

Tamsulosin

Mirabegron

Adrenergic Agents

Adrenergic beta-3 Receptor Agonists

Adrenergic beta-Agonists

Adrenergic Agonists

Neurotransmitter Agents

oral mirabegron 50 gm plus tamsulosin 0.4 mg once daily for 8 weeks

oral toltordine 4 mg plus tamsulosin 0.4 mg daily for 8 weeks.

oral mirabegron 50 gm plus tamsulosin 0.4 mg once daily for 8 weeks.

placebo

Ahmed Shokeir, PhD

To study the impact of mirabegron, a B3-adrenoceptor agonist, in the treatment of ED in patients with LUTS secondary to BPH and concomitant ED.

Erectile dysfunction (ED) is a major world-wide problem. In United Stated of America, ED affects 26/1000 man yearly (Gonzalgo et al., 2003). The prevalence of ED increases with age from 2-9% in men between 40-49 year, to 20-40% between 60-69 and between 50-100% over 70 years (Gur et al., 2006; Hojanned et al., 2000; Gades et al., 2009; Braun et al., 2000). Many factors may contribute in the occurrence of ED including neuronal, vascular, myogenic and psychological causes (Gur et al., 2016; Johannes et al., 2000, Lewis et al., 2000; Wu et al., 2010; Mallis et al., 2005).

Researchs during the past decade have ﬁrmly established that ED and ejaculatory dysfunction (EJD) are highly prevalent in aging men, particularly those with LUTS of BPH. Furthermore, it has been demonstrated that LUTS of BPH is an independent risk factor for male sexual dysfunction (Hansen BL. et al., 2004).

Although the underlying mechanisms responsible for the relationship between LUTS and male sexual dysfunction are not fully elucidated, possible common links are present including activation of a-adrenergic receptors, endothelial dysfunction, and alterations in sex hormone concentrations and receptor subtypes. Thus, it is now recommended that men presenting with LUTS should be evaluated for sexual dysfunction and those presenting with sexual dysfunction should be evaluated for LUTS (Price DT., et al., 1993).

Also , it is now recognized that certain oral therapies for LUTS/BPH can adversely affect sexual function in patients who are already at increased risk for sexual dysfunction. Moreover, the correction of LUTS was associated with improvement of ED. (De Rose AF., et al., 2002) Healthcare providers should discuss sexual function with BPH patients both before and during treatment. (Raymond C. Rosen et al., 2005) So, use of ED-treating drugs (phosphodiestrase -5 inhibitors) is now a guideline recommendation in the lines of treatment of BPH/LUTS alone or in combination with α blockers. (EUA guidelines, 2015, Gratzke C et., al., 2015).

Phosphodiesterase 5 inhibitors (PDE5i) are effective in treatment of ED. They treat ED through enhancement of the effect of nitric oxide (NO) by inhibition of cyclic guanosin monophosphate (cGMP) breakdown, therefore, increase blood flow through penile arteries. PDE5i are the first-line treatment of ED. Nevertheless, many patients may discontinue the treatment because of side effects, poor response or cost.

It has been shown that B3-adrenoreceptors are mainly localized in the smooth muscle cells of human corpora cavernosa (HCC) (Cirino et al., 2003). The activation of B3-adrenoceptors cause relaxation of the vascular smooth muscle of HCC. Investigators showed that a B3- adrenoreceptors agoinst named "BRL37344" induces relaxation of the HCC. This relaxation has been shown to be linked to inhibition of the RhoA-Rho-associated protein kinase (ROCK) pathway (Cirino et al., 2003). The effect of BRL37344 is mediated by cGMP-dependent but NO-independent mechanisms, altering CC smooth muscle tone and promoting erectile function (Cirino et al., 2003). Thus, b3-adrenoceptor agonists may also serve as potentially useful drugs for the treatment of ED.

Mirabegron is a selective B3-adrenoreceptor agonist and is currently approved in many parts of the world for treatment of overactive bladder (Chapple et al., 2013; Khullar et al., 2013; Chapple et al., 2013; Nitti et al., 2013). Mirabegron displayed 20-200 times higher relative efficacy for human B3-adrenoceptor than that BRL37344 (Takasu et al., 2007). Mirabegron increases intracellular cAMP levels and activates cAMP-dependent protein kinase A resulting in relaxation of the human urinary bladder through a cascade of mechanisms including decrease in intracellular cytoplasmic Ca2+ (Imran et al., 2013; Matanake et al., 2013).

Recently , Gur et al studied the effect of mirabegron on HCC in vitro study and also examined the impact of the drug in vivo, after intracavernosal injection of rats. Authors showed that mirabegron caused marked relaxation of HCC by activating B3-adrenoceptors independently of No pathway. So it appears that mirabegron may be apotential safe and effective therapeutic agent for ED. (Gur et al., 2016) Herein, we designed this protocol to evaluate the role of mirabegron in treating ED in men with BPH/LUTS with concomitant ED.

Mirabegron for Treatment of Erectile Dysfunction in Patients With LUTS Secondry to BPH: A Randomized Study

measured by International Index of Erectile Function (IIEF).

measured by International Prostate Symptom Score (I-PSS)

Mansoura University

Infections

Communicable Diseases

Diarrhea

Signs and Symptoms, Digestive

Anti-Infective Agents

Antineoplastic Agents

Anti-Bacterial Agents

Levofloxacin

Ofloxacin

Antibiotics, Antitubercular

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.

Koenraad van Renterghem, PhD

To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or \> 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.

Main objective:

To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or \> 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).

Secondary objective:

To investigate post-operative bacteriuria after TURB and TURP in our population.

Principal inclusion criterium:

Patients undergoing TURP or TURB.

Primary exclusion criterium:

TURP: pre-operative catheter or \> 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).

Primary endpoint:

Post-operative infection.

Secondary endpoint:

Post-operative bacteriuria.

Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)

A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial

Urosepsis, fever (t°\> 38.5) or epididymitis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostate Metabolism, Cancer Risk and Gut Microbiota	NCT06116851	Prostate Cancer Prostate Hyperp...	MRI scan and la... Prostate biopsi... Radical prostat... TURP and blood,... Radical cystopr...	18 Years -	Turku University Hospital
Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications	NCT01876836	Bladder Tumour Prostate Hyperp...	i-gel C-LMA	19 Years - 70 Years	Diskapi Yildirim Beyazit Education and Research Hospital
Mirabegron for Treatment of Erectile Dysfunction in Patients With LUTS Secondry to BPH: A Randomized Study	NCT03600766	BPH Erectile Dysfun... Prostate Hyperp... Erectile Abnorm... Prostatic Neopl...	Mirabegron placebo	50 Years - 70 Years	Mansoura University
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)	NCT04212403	Urosepsis Bladder Cancer Prostate Hyperp... Antibiotic Resi... Antibiotic Resi... Antibiotic-asso... Antibiotic Toxi...	Levofloxacin	18 Years -	Jessa Hospital
Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications	NCT01876836	Bladder Tumour Prostate Hyperp...	i-gel C-LMA	19 Years - 70 Years	Diskapi Yildirim Beyazit Education and Research Hospital

Spots Global Cancer Trial Database for prostate hyperplasia