Active clinical trials for "Prostatic Neoplasms"

The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.

NC ProCESS is a cohort of patients from diverse backgrounds diagnosed with early prostate cancer, who were enrolled from January 2011-June 2013. These patients were recruited throughout North Carolina, and also in partnership with institutions across the country. Patients enrolled before they start treatment, and are then followed prospectively through treatment and then afterwards. This observational study collects information on quality of life, cancer control, and health care received inclusive of treatment and management of subsequent effects including complications and recurrence. The objective of this study is to examine comparative outcomes among different modern prostate cancer treatment options in this cohort of patients.

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.

The purpose of the study is to collect information on prostrate biopsy tissue for use in developing a method determining the difference in normal and cancerous prostrate tissue using the ClariCore System.

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.

This study aims to answer the research question: Are Japanese bone metastatic CRPC patients satisfied with their Ra-223 treatment, and what factors drive such satisfaction? It also aims to determine patient anxiety regarding prostate cancer while on treatment with Ra-223, and assess the effect on quality of life.

This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy. The indication for treatment with Radium-223 will be at the physician's decision. All patients treated with Radium-223 can be included in this registry. The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.

1.0 Background & Introduction Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from radiolabelled tracers. This technology allows biologic processes to be visualized and measured on whole body images. Common radiotracers in use today in the USA and Europe are radiolabelled choline derivatives such as the analogs 18F-fluoromethylcholine (FMCh) and 18F-fluoroethylcholine (FECh), or more broadly FCH. Both of these fluorinated choline analogs have been extensively studied and display seemingly identical biological, radiopharmaceutical and radiochemical properties. Both have been extensively studied in human prostate cancer, with FMCh having slightly more published data than FECh. Imaging with radiolabelled choline derivatives is used to determine sites of abnormal choline metabolism and can be used to characterize prostate cancer, for which there is extensive data in the literature. PET/CT with radiolabelled choline derivatives is considered standard of care by some experts where available, however at the JGH, anatomic imaging with CT and MRI, and bone scan are the current diagnostic imaging modalities in use for this patient population. Prostate cancer cells have increased choline uptake compared to normal tissues, forming the molecular basis for this technique. The Gleason score, a histopathologic measure of tumor aggressiveness, is one of the most important prognostic factors in the disease. The objective of this study is to evaluate if the degree of uptake measured by maximum standard uptake value (SUVmax) on FCH PET/CT in prostate cancer correlates with Gleason score at initial biopsy. 2.0 Study Objectives The objective of this study is to evaluate if the patient-wide SUVmax on 18F-FCH PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score. This is of interest because non-invasive risk stratification may be possible in the future. 3.0 Study Design This will be a single-site JGH-only open label study in which one (1) 18F-FCH PET/CT will be performed on study participants. A PET/CT scan takes about 3 hours. 4.0 Safety & Ethics The radiation dose to patients from fluorinated choline derivatives compares favorably to the major PET tracer in widespread clinical use, 18F-fluorodeoxyglucose (18F-FDG). The safety of fluorinated choline derivatives is not disputed and the investigators expect the number of adverse events in this study to be at (or near) zero. There is no established toxicology for diagnostic doses of fluorinated choline derivatives. There are no salient ethical considerations identified. The treating physicians are free to order any diagnostic or therapeutic intervention on study patients, and care will not be modified or restricted in any way. Treating physicians are free to incorporate information acquired with this study or discard it if it is not relevant. Care of the patients may be improved with additional information provided by FCH PET/CT, but it is otherwise unchanged. No vulnerable populations will be included in the study. 5.0 Confidentiality All information (medical history, physical examination, and PET/CT results) will be kept strictly confidential and only authorized personnel will have access. The reports of the PET/CT will be contained in a password protected radiology & nuclear medicine RIS database (RadImage) where all other diagnostic imaging reports are securely stored. Clinical PET/CT reports will be stored indefinitely, whereas all other study data will be kept locked by the PI and destroyed after 10 years. 6.0 Population, Sample Size and Recruitment A maximum of 225 competent adult male medically stable prostate cancer patients with available Gleason Scores will be entered into the study. Patients will be recruited by urologists in the clinical setting. Initial contact and consent will be by the department of urology.

There have been calls from patients, payers, healthcare providers, and policy makers for an evaluation of newer, high-cost radiation technologies compared to conventional forms of radiation therapy. National attention has focused on the use of intensity modulated radiation therapy (IMRT) into routine daily clinical practice for prostate cancer. The goal of the present study is to determine whether the type of radiation treatment received by the patients can result in a reduction in patient-relevant side effects following prostate irradiation. The analysis will be performed by obtaining patient answered surveys looking at side effects.

The purpose of this study is to provide real world data on treatment with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients. The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) (post chemo patients). This study will also evaluate treatment duration with enzalutamide in patients pre- and post-chemo.