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Prostate Cancer clinical trials

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NCT ID: NCT02905318 Active, not recruiting - Prostate Cancer Clinical Trials

Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer

Start date: July 4, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out what effects a new drug, palbociclib, has on prostate cancer and will look at the side effects of treatment with palbociclib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by palbociclib and to see how the cancer cells respond to palbociclib.

NCT ID: NCT02903368 Active, not recruiting - Prostate Cancer Clinical Trials

Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy

Start date: October 19, 2016
Phase: Phase 2
Study type: Interventional

This multicenter randomized phase II trial investigates the impact of intense androgen deprivation on radical prostatectomy (RP) pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368).

NCT ID: NCT02903160 Completed - Prostate Cancer Clinical Trials

Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)

Start date: January 13, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the clinical benefits of using a rapidly cycling, non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the management of castration resistant prostate cancer. The hypothesis is that the identification of optimal combinations and sequencing of therapies can help prevent or delay the development of therapeutic drug resistance, and can be safely tolerated.

NCT ID: NCT02899312 Recruiting - Prostate Cancer Clinical Trials

PSMA PET/CT for Assessment of Recurrent Prostate Cancer

Start date: March 16, 2017
Phase:
Study type: Observational

Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients will have their PC return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate-specific antigen (PSA) levels. This study proposes to use Fluorine-18-2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pen tanedioic acid (18F-DCFPyL) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the PC has recurred.

NCT ID: NCT02895854 Active, not recruiting - Prostate Cancer Clinical Trials

LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients

BRAVEROBO
Start date: January 8, 2013
Phase: N/A
Study type: Interventional

The aim of this trial is to find out if there are any differences in the profiles of acute and late adverse effects among men with low and intermediate risk prostate cancer treated either with low dose-rate brachytherapy or hypofractionated external radiotherapy (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each treatment will be analysed.

NCT ID: NCT02895230 Completed - Prostate Cancer Clinical Trials

Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study

ADTCR
Start date: January 1, 2016
Phase:
Study type: Observational

The research focuses on the safety profile of androgen-deprivation therapy (ADT). The hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT modalities including intermittent ADT. ADT is a cornerstone therapy in prostate cancer management. Decisions about ADT should weigh improvements in cancer-specific outcomes against potential increased risks for cardiovascular diseases. The potential for harm from ADT should be more precisely defined according to the type of ADT. Those potential risks underscore the importance of better understanding benefits of ADT, especially in contexts where data are still lacking.ADT is also indicated in sexually deviant behavior.

NCT ID: NCT02887976 Completed - Prostate Cancer Clinical Trials

Extension of SoluMatrix TM Abiraterone Acetate in Patients Who Completed Study Number CHL-AA-201

Start date: September 2016
Phase: Phase 3
Study type: Interventional

An Open-label extension (OLE), expanded access study, to assess long-term safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in patients who completed study number CHL-AA-201.

NCT ID: NCT02886598 Completed - Prostate Cancer Clinical Trials

Safety and Efficacy of Firmagon® (Degarelix) for Injection

Start date: September 2016
Phase:
Study type: Observational

The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea.

NCT ID: NCT02886546 Not yet recruiting - Prostate Cancer Clinical Trials

Utility of Dynamic Variables Measured by Calibrated Pulse Contour Analysis of Oesophageal Doppler Monitor for Predicting Fluid Responsiveness During Robot-Assisted Laparoscopic Prostatectomy

Start date: September 2016
Phase: N/A
Study type: Interventional

Robot-assisted laparoscopic prostatectomy (RALP) is widely performed due to its many advantages, including a reduced need for blood transfusion and fewer surgical complications compared with conventional open prostatectomy. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important. Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV) are used to predict and guide fluid therapy during controlled ventilation. These variables arise from heart-lung interactions during positive pressure ventilation, which influence left ventricular stroke volume (SV). RALP requires carbon dioxide insufflation and the steep Trendelenburg position to optimise surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV, which are affected by changes in intrathoracic pressure, in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned. A recent study established that PPV and SVV derived by uncalibrated pulse contour analysis had a relatively poor capacity to predict fluid responsiveness during laparoscopy on dynamic preload indices. In contrast, another study SVV measured by oesophageal Doppler monitor (ODM) could predict fluid responsiveness during laparoscopic surgery. The CardioQ-ODM+ combines the proven ODM Doppler measurement of blood flow with pulse contour analysis, which is quickly and easily calibrated from the Doppler signal. We hypothesized that PPV and SVV measured by calibrated pulse contour analysis would be a good indicator of fluid responsiveness during laparoscopy with pneumoperitoneum. The primary objective of this study was to demonstrate that PPV and SVV measured by calibrated pulse contour analysis of CardioQ-ODM+ can accurately predict fluid responsiveness during RALP, which involves both pneumoperitoneum and the Trendelenburg position. Investigators also assessed the capacity of other dynamic variables (SPV [systolic pressure variation], and SVV determined by ODM Doppler flow, dynamic elastance [PPV/SVV] and corrected flow time [FTc]) to predict fluid responsiveness during RALP.

NCT ID: NCT02883166 Completed - Prostate Cancer Clinical Trials

Improving Bio-availability of the Expensive Oral Oncolytic Drug Abiraterone by Food Intake

SNACK
Start date: August 2016
Phase: Phase 1
Study type: Interventional

Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis. A pro-drug of abiraterone, abiraterone acetate (Zytiga®), was developed to overcome its poor bio-availability and is fully converted to the active moiety abiraterone. Abiraterone acetate tablets are administered at a fixed oral dose of 1000mg QD in a fasted state in combination with 10mg prednisolon daily. Abiraterone acetate has a low solubility in aqueous media and a low permeability. The bioavailability of abiraterone acetate is significantly influenced when ingested with food. Ingesting abiraterone acetate with a low fat or a high fat meal resulted respectively in a 5- or 10-fold increase in AUC0-∞. The high and low fat FDA meals used in these food effect studies differ largely from breakfasts taken in everyday life (ca. 800-1000 cal). A continental breakfast contains 160 to 320 calories of which 25-50% is fat, is more compatible with a normal lifestyle and therefore easily sustainable in daily practice. However, the effect of a continental breakfast on the absorption of abiraterone is unknown yet. Furthermore, increasing healthcare costs are a growing concern in all developed countries. Therefore effort should be invested to keep anticancer treatment affordable. A food intervention resulting in a better absorption and enhanced exposure to abiraterone, can lead to a reduced dose, which could significantly impact health care costs for a tumor which is as prevalent as metastatic prostate cancer. Therefore the investigators want to perform a bioequivalent study to investigate what dose of abiraterone with a continental breakfast equals the dose of 1000mg taken in fasted conditions.