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Prostatic Neoplasm clinical trials

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NCT ID: NCT05566405 Completed - Prostatic Neoplasm Clinical Trials

The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy

Start date: July 27, 2020
Phase: N/A
Study type: Interventional

Prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. The gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. The open retropubic approach, still performed today, can be completed under either general anaesthesia or combined (spinal/epidural) anaesthesia without any clear guideline on which one should be preferred. In this study the investigators aim to evaluate general anaesthesia and combined (spinal/ epidural) anaesthesia in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the oncological outcome and safety of the procedure.

NCT ID: NCT04398173 Completed - Prostatic Neoplasm Clinical Trials

Detection Rate of Prostate Cancer in Men Undergoing MRI

Start date: November 1, 2014
Phase:
Study type: Observational

To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy. Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.

NCT ID: NCT03982095 Completed - Physical Activity Clinical Trials

Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer

PCa_LS
Start date: September 4, 2019
Phase:
Study type: Observational

Prostate cancer (PCa) is among the most widespread in the male population and represents 20% of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT) is a common strategy of treatment that is used for increase survival. However, ADT is associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline and reduced quality of life, with an increased the risk for falls and fractures, cardiometabolic syndrome and cardiovascular events. The numerous side effects from ADT could potentially be countered by the regular Physical Exercise (PE), with favorable effects on body composition, physical performance, bone health and cognitive function. However, to maintain the results obtained, PE must be undertaken regularly, becoming a healthy habit of life. The patient motivation is therefore a fundamental element for guaranteeing adherence to the intervention and its integration into people's lifestyle. The study aim is to analyzed patients with PCa at the time of diagnosis regarding their lifestyle, includes regular PE, and motivation to make changes about their habits. In addition, the investigators will describe the perceived barriers by patients about this change. The data collected will allow the development of an experimental intervention of PE, associated with therapeutic education, and assess its impact on the health of patient undergoing ADT, considering the realistic possibilities of application in the daily life of these patients, testing its feasibility and safety, the compliance and the satisfaction of the patients.

NCT ID: NCT03947515 Completed - Prostatic Neoplasm Clinical Trials

Urinary and Prostate Microbiotes and Prostate Cancer

MICROPROSTK
Start date: February 4, 2021
Phase: N/A
Study type: Interventional

In recent decades, the cancer process has been linked to microbial infections, particularly in gastric and Helicobacter pylori cancers, but also in cervical cancers promoted by exposure to Human papilloma virus (HPV). More recently, it has been shown that bacteria in the intestinal microbiota could promote the development of colorectal cancer by modulating the inflammatory response within the intestinal mucosa. Among male cancers, prostate cancer is the leading cause in France with 54,000 new cases per year. In addition, the dogma that urine is sterile has been broken and the notion of the presence of a "urinary microbiota" in asymptomatic patients is now accepted. While the risk factors associated with this cancer have not yet been clearly elucidated, recent evidence in the literature agrees that chronic inflammation associated with prostate infection plays a key role as a factor that may promote the development and/or progression of prostate cancer. Most recently, a study shows for the first time that a group of 6 bacteria is found significantly higher in the urine of patients with prostate cancer than in patients with prostate adenoma. Interestingly, clinical microbiology studies conducted at the bacteriology laboratory of the University Hospital of Nice on A. schaalii have shown that this species is also isolated in the urine of patients with bladder and prostate cancers. The investigators wish to study the association of the 6 bacterial species mentioned above with prostate cancer by directly analyzing the prostate tissue of patients with this condition. the staff will carry out a multicenter case-control study by recruiting a total of 260 patients in 4 centres (Nice coordinating centre, Marseille, Tours and Nîmes): 130 in the prostate cancer group and 130 in the prostate adenoma control group. This project is a research involving the human person of category 2. The innovative aspect of the work consists in detecting and quantifying in situ in the prostate tissue the presence of these 6 bacterial species per culture and per PCR in real time, comparing the prostate microbiota in terms of richness and diversity between cancer patients and those without cancer. Ultimately, this study opens up exciting prospects with the possibility of determining a microbial origin of prostate cancer and considering antibiotic therapy for anti-cancer purposes such as H. pylori and gastric cancer.

NCT ID: NCT03693742 Completed - Prostate Cancer Clinical Trials

MSG Use With 18F-DCFPyL PET/CT Imaging

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

18F-DCFPyL is an agent that binds to prostate specific membrane antigen (PSMA). Due to high levels of PSMA in prostate cancer, treatments targeting PSMA have been developed to deliver therapy to these specific target cells. Unfortunately when this treatment is delivered there is radiotracer uptake in the salivary glands and kidneys, not related to cancer, which causes dry mouth and causes patients to stop treatment. It is proposed that having tomato juice containing monosodium glutamate (MSG) may reduce radiotracer uptake in the salivary glands and kidneys and reduce damage to these tissues.

NCT ID: NCT03693703 Completed - Prostatic Neoplasm Clinical Trials

Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer

Start date: April 18, 2018
Phase: N/A
Study type: Interventional

To compare the detection rate of biparametric (bp) magnetic resonance imaging (MRI) for clinically significant prostate cancer (PCa) with that of multiparametric (mp)-MRI, in biopsy-naïve patients. Today, bp-MRI is not the standard diagnostic procedure, however preliminary studies showed its non-inferiority with respect to mp-MRI. Its implementation on a wide scale could significantly reduce examination costs (no iv contrast agent and no endorectal coil), and study time. Secondary objectives will be: - to assess specificity of a blood test based on microRNA (miR) score in biopsy-naïve patients, using pathological assessment after MR-guided biopsy as reference standard. If specificity of the miR score is higher than that of PSA, then fewer patients will undergo unnecessary MRI, thus increasing the efficiency of the diagnostic pipeline for PCa; - to develop a clinical decision support system (CDSS) based on MRI and circulating miR evaluation, to stratify patients according to their risk of PCa progression, using pathological assessment after prostatectomy as reference standard. Patients will be stratified into two classes of risk: i) low-risk PCa, in which patients may benefit from a conservative approach (i.e. active surveillance), and ii) medium/high-risk PCa in which patients should undergo radical treatment (i.e. surgery or radiation therapy).

NCT ID: NCT03397030 Completed - Prostatic Neoplasm Clinical Trials

Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer

Start date: January 5, 2017
Phase: N/A
Study type: Interventional

The goal of this study is to demonstrate the impact of a home based exercise program versus wait-list control to modulate circulating prognostic biomarkers in men with prostate cancer under active surveillance.

NCT ID: NCT03388346 Completed - Prostate Cancer Clinical Trials

68Ga PSMA in Preprostatectomy Patients

Start date: February 16, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

NCT ID: NCT03361969 Completed - Prostatic Neoplasm Clinical Trials

Evaluation of Effects of Estetrol on Testosterone Suppression and Quality of Life in Prostate Cancer Patients Treated With an LHRH Agonist.

Start date: April 16, 2018
Phase: Phase 2
Study type: Interventional

This is a phase IIa, double-blind, randomised, placebo-controlled, multi-center study to evaluate the effects of estetrol on testosterone suppression and quality of life in prostate cancer patients treated with an LHRH agonist. Patients will be treated with estetrol or placebo for 6 months.

NCT ID: NCT03348722 Completed - Prostatic Neoplasm Clinical Trials

Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer START

START
Start date: May 15, 2015
Phase:
Study type: Observational

The purpose of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer.