View clinical trials related to Prostate Cancer.
Filter by:This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such as ultrasound, may help find prostate cancer and find out how far the disease has spread during surgery
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
Prostate cancer is one of the most common malignancies affecting men all over the World. Metastatic prostate cancer responds to androgen deprivation for a variable period (20-25 months). Prostate cancer that grows despite castrate levels of testosterone and that no longer responds to any form of hormonal manipulation is defined as castrate resistant prostate cancer (CRPC). Docetaxel combined with prednisolone has been shown to not only improve QOL and PSA response in CRPC, but also extend the overall survival1. However, the efficacy of the drug has not been universally effective, and nearly all patients have disease progression after docetaxel treatment. After failure of a docetaxel regimen, With the exception of cabazitaxel or abiraterone, which are not widely and easily availabe in Korea, little treatment regimen can be applied to the patients with reasonable response and benefits. Gemcitabine is a nucleoside analog with activity against a broad spectrum of solid tumors. When gemcitabine is used as first-line therapy for CRPC, disease control rate was 33% with median duration of 7.1 months. When it is combined with prednisone and zoledronic acid in pretreated patients with CRPC, the PSA response rate was 23% with a disease control rate of 57% in patients with measurable disease. Oxaliplatin is newer platinum agent that has favorable toxicity profile and evidence of activity in cisplatin-resistant cell lines. Droz et al. performed a multicenter phase II study in 54 patients with metastatic CRPC who were randomized to receive oxaliplatin either alone or with 5-FU. More than 50% of the patients had received prior chemotherapy including cisplatin. Despite heavy pretreatment, PSA desclines were noted in 11% and 19% of patients in each arm. Gemcitabine plus oxaliplatin combination was widely studied and has been reported to be safe and effective in various cancers. This study is to assess the efficacy and safety of GEMOX in docetaxel-refractory CRPC.
The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.
This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.
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.
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.
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.
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.
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.