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Prostate Cancer clinical trials

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NCT ID: NCT01484665 Completed - Prostate Cancer Clinical Trials

Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening

Start date: December 2011
Phase: N/A
Study type: Interventional

Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. However, no consensus exists as to how best educate and involve patients in the shared-decision making process. The goal of this study is to evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of African-American patients. The investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their decision about whether to receive PSA testing, and on the comfort level of physicians on their patient's decisions regarding PSA testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. If successful, this program may serve as a model for the broader implementation of such strategies across Minnesota and the country.

NCT ID: NCT01483586 Terminated - Prostate Cancer Clinical Trials

Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

Start date: November 2011
Phase: Phase 2
Study type: Interventional

This research is being done to evaluate the safety and efficacy of the investigational Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.

NCT ID: NCT01481441 Terminated - Prostate Cancer Clinical Trials

Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

AMC_2011_190
Start date: November 2011
Phase: N/A
Study type: Interventional

With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva. The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature. Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.

NCT ID: NCT01481233 Withdrawn - Prostate Cancer Clinical Trials

Oral Colchicine in Men With Castrate Resistant Prostate Cancer

Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.

NCT ID: NCT01480375 Completed - Prostate Cancer Clinical Trials

A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy

NaSBxP01
Start date: September 22, 2011
Phase: N/A
Study type: Interventional

he most common method for performing a prostate biopsy procedure is the ultrasound guided transrectal procedure. The information obtained from the standard prostate biopsy is deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy. Moreover, the detection of a tumor cannot predict accurately the tumor size and location1. It was proven that the exact location of the obtained cores, even in an initial biopsy, can influence the cancer detection rate2. An imaging tool that will enable a three-dimensional navigation in the prostate volume and selecting biopsy locations in view of previous core taken will allow building a "tumor map" '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate treatment can be chosen while avoiding over or insufficient treatment. However, to be able to produce an accurate mapping of the malignant tissue, a complementary optimized pathology method should be also implement in addition to the navigation system, it has been shown that a pre-embedding procedure that keeps the specimen orientation, unfolding, unity, and location along the needle notch improves the histological yield and hence the cancer detection rate3. The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows physicians to see the prostate gland together with the biopsy sites in a three dimensional (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as an adjunct to standard of care procedures, to work with standard rectal ultrasound probes, and to be incorporated side by side with the techniques currently employed. No change to the current employed procedures and techniques is required or suggested. In complementary to the Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the orientation, unfolding and unity of the sample was developed to increase the pathology utility. The study objective is to evaluate the contribution of the Navigo™ system, an aiding navigation tool for TRUS prostate biopsy, to an increase in the prostate cancer detection ability.

NCT ID: NCT01478828 Terminated - Prostate Cancer Clinical Trials

Pre-Prostatectomy Lovastatin on Prostate Cancer

Start date: July 13, 2012
Phase: N/A
Study type: Interventional

To determine the dose of continuous daily oral lovastatin needed to achieve MYC [v-myc myelocytomatosis viral oncogene homolog (avian)] down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.

NCT ID: NCT01478308 Withdrawn - Prostate Cancer Clinical Trials

Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer

Start date: June 2011
Phase: Phase 2
Study type: Interventional

This study is being conducted to determine the effectiveness of standard 3 weekly treatments using docetaxel and prednisone with metformin in patients with castration-resistant metastatic prostate cancer. It is also being conducted to determine the levels of toxicity of metformin when added to every 3 weekly docetaxel treatments in patients with endocrine resistent, metastatic prostate cancer.

NCT ID: NCT01477749 Completed - Prostate Cancer Clinical Trials

Sipuleucel-T Manufacturing Demonstration Study

Start date: June 2012
Phase: Phase 2
Study type: Interventional

To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

NCT ID: NCT01459653 Completed - Breast Cancer Clinical Trials

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor

Monitor-GCSF
Start date: March 2010
Phase: N/A
Study type: Observational

This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.

NCT ID: NCT01455792 Completed - Prostate Cancer Clinical Trials

Biopsy Study Comparing MRI and Ultrasound Soft Image Fusion Guided Biopsies and Gold Standard Prostate Biopsies.

Start date: September 2011
Phase: N/A
Study type: Interventional

Background: Prostate biopsies are usually performed due to accidentally discovered elevated prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal ultrasound (TRUS) guided biopsy is standard procedure, but possibility for precise documentation concerning the localization of the biopsies are lacking. Therefore, the same locations might be subject to multiple negative biopsies. There is a growing confidence that magnetic resonance imaging (MRI) of the prostate gland can identify significant, high-grade tumours, and studies have shown value in performing MRI before biopsies. Because image documentation is lacking, it is not possible to know which region actually being biopsied with conventional TRUS biopsy. MRI and 3D ultrasound soft image fusion guided biopsy, is a new promising method that will ascertain all regions of the prostate gland to be biopsied, and it is possible to perform accurate targeted biopsies when combined with MRI. Aims of the study Compare the biopsy results in the two groups: 1. To evaluate the overall rate of positive biopsies. 2. To evaluate the rate of re-biopsies. 3. To evaluate the detection rate of Gleason grade 4 and 5 tumours. 4. To evaluate the rate of positive targeted biopsies. 5. To evaluate the rate of positive random biopsies 6. To compare targeted and random biopsies between groups. 7. To compare patient tolerance, time consumption and cost of the two methods. 8. To evaluate the diagnostic accuracy of performing cytological imprints of targeted biopsies. Material and methods: A prospective randomized study including 300 consecutive patients referred to the initial biopsy. The patients are randomized to conventional TRUS biopsies and image fusion guided biopsy. All patients undergo a minimum 12-core re-biopsy procedure. In addition a targeted biopsy will be obtained in case of positive MRI of ultrasound.