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Prostate Cancer clinical trials

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NCT ID: NCT03182998 Not yet recruiting - Prostate Cancer Clinical Trials

Decision Aids to Improve Knowledge in Patients With Prostate Cancer

Start date: June 11, 2017
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

NCT ID: NCT03181867 Not yet recruiting - Prostate Cancer Clinical Trials

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

Start date: June 23, 2017
Phase: Phase 2
Study type: Interventional

Background: Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment. Objectives: To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy. Eligibility: Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery Design: Participants will be screened with medical history and physical exam. They will have blood taken. Participants will be divided into 2 groups. - Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy. - Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy. Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line. Participants will be contacted for follow-up after scans. Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV. Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan. Participants will have data about their prostate cancer collected for up to 1 year.

NCT ID: NCT03180398 Not yet recruiting - Prostate Cancer Clinical Trials

Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

This is a pilot study of implement multi-parametric MR imaging for organ delineation and tumor response assessment of prostate cancer patients being treated with radiation therapy. The study aims to generate intraprostatic lesions maps based on imaging, perform the treatment planning to compute the highest feasible simultaneous boosting dose to intraprostatic lesion and characterize longitudinal changes in imaging characteristics.

NCT ID: NCT03179410 Not yet recruiting - Prostate Cancer Clinical Trials

PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer

PICK-NEPC
Start date: August 31, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of avelumab in patients with metastatic neuroendocrine-like prostate cancer. Eligible men will be started on avelumab every 2 weeks and will stay on therapy until progression or intolerable side effects. The central hypothesis is that PD-L1 inhibition with avelumab will be efficacious based on radiographic responses in a subset of men with metastatic neuroendocrine-like prostate cancer and be reasonably well tolerated, meeting criteria for further study in larger phase 2 and 3 trials based on meeting pre-specified efficacy rates and prolonged PFS in some men.

NCT ID: NCT03174054 Not yet recruiting - Prostate Cancer Clinical Trials

The Value of PSMA-PET Compared With Multi-parametric MRI in the Detection Prostate Lesions

Start date: June 1, 2017
Phase: N/A
Study type: Observational

Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to increased PSA levels or clinical suspicion, are false negative, despite malignancy. Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging devices. A sonar-guided prostate biopsy based on multi-parametric MRI images improves detection of malignancy. Ga68 PSMA-PET test uses a radioactive marker that binds to the prostate's cells and is shown to be a primary prostate tumor site in addition to metastasis. We believe that the combination of measures from a single Ga68 PSMA and multi-parametric MRI test can lead to further improvement in malignancy, better biopsy guidance, and optimal treatment for the patient.

NCT ID: NCT03173807 Not yet recruiting - Prostate Cancer Clinical Trials

Prostate Nutrition and Exercise STudy (ProNEST)

ProNEST
Start date: August 31, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to test the feasibility of nutrition and exercise counseling program for reducing the incidence of metabolic syndrome in prostate cancer patients on Androgen Deprivation Therapy.

NCT ID: NCT03160365 Not yet recruiting - Prostate Cancer Clinical Trials

Innovative Planning and Guidance System for Prostate Focal Brachytherapy

FOCUS
Start date: September 4, 2017
Phase: N/A
Study type: Interventional

A key feature of low-dose brachytherapy is that irradiation affects only a local area around the inserted radiation sources. The exposure of healthy tissues around these sources is then reduced. However, the number of adverse events remains high (about 79% of patients with sexual problems and 30% of patients with urinary incontinence) and brachytherapy is no better than other treatment options for Preservation of the urethral apparatus (about 40% of patients). The current technique for the implantation of radioactive sources, which has not been revised since the early 1980s, consists in imaging the prostate at the beginning of the intraoperative procedure with transrectal ultrasound in order to evaluate the size and shape of the prostate . This information is then used to identify the best distribution of the dose of radiation to be administered to each patient. This treatment planning step is based on a procedure where the operator manually places 50 to 100 grains of iodine in the prostate. These grains are inserted transperinally under transrectal 2D ultrasound control, using needles through a transperineal grid with several needle guides evenly spaced 5 mm apart. This is an arduous task because this manual grain placement procedure must take into account the dose to be administered to the prostate without exceeding the dose limit for the surrounding organs at risk (rectum, urethra). In addition, the overestimation of the dose formality called TG-43 and the inaccurate grain placement can contribute to the creation of cold spots where no dose is administered. It may be responsible for recurrences of prostate cancer after brachytherapy treatment. Although brachytherapy dosimetry has been extensively researched, the TG-43 dose formalism has been the benchmark for the last 20 years. Moreover, from an economic point of view, the high side-effects rates of the treatment of prostate cancer result in particularly expensive post-treatment costs. The search for improved solutions for the treatment of prostate cancer remains a major societal challenge. In recent years, a very attractive therapeutic alternative between active surveillance and overall treatment is gaining popularity among experts: focal therapy. It is a localized treatment, limited to cancerous areas, in order to preserve healthy functional tissues inside and outside the organ and thus the quality of life of the patient. Focal therapy is also often the preferred solution for recovery therapy (second intervention). Finally, focal therapy has great potential to reduce the cost and duration of the intervention, as well as the cost of follow-up. In recent years, several energies have been proposed as being adapted to focal therapy, such as high intensity focal ultrasound, laser ablation and cryotherapy. Brachytherapy, which already gives above average results in the treatment of whole glands, has been identified as a very good candidate for this new therapeutic paradigm. In brachytherapy, radioactive grains are implanted in the prostate using transperineal catheters. The rapid reduction of the dose according to the distance of the radioactive seeds gives the physician a great flexibility to control the radiation accurately. It allows intermediate approaches between global and focal treatments, providing great scalability, and it is a good candidate for recovery therapy. Recent studies have shown that focal brachytherapy allows more than half of the needles and seeds to act more strongly on the target while irradiating Significantly less The urethra and rectum. Clinical studies on this subject are still limited and further research is needed to confirm the performance of this approach.

NCT ID: NCT03157947 Not yet recruiting - Prostate Cancer Clinical Trials

Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

Start date: September 2017
Phase: N/A
Study type: Interventional

A pilot study testing the effect of an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice. Subjects will be followed for approximately 1 year during standard care in-clinic office visits. Study results and subject surveys will be analyzed to determine clinical utility of the tool.

NCT ID: NCT03151356 Not yet recruiting - Prostate Cancer Clinical Trials

Prostate Health Index for Prostate Cancer Diagnosis

PHI-1
Start date: July 2017
Phase: N/A
Study type: Observational

Prostate biopsies are the gold standard for prostate cancer (PCa) diagnosis. They are performed according to the results of the measurement of prostate-specific antigen (PSA) in the serum of patients with PCa suspicion. More than half of the prostate biopsies reveal eventually negative because of the poor specificity of prostate-specific antigen assay. The Prostate Health Index (PHI) is a new diagnostic tool that has been described as a good predictor of prostate biopsy outcome. No large study has been performed so far in France. This study aim to evaluate Prostate Health Index diagnostic performances in a large multicentric French cohort of patients undergoing prostate biopsies because of clinical and/or biological suspicion of prostate cancer. Prostate Health Index will be measured in patients directed to prostate biopsies according to usual practices. Inclusion of 400 patients within 6 months in 12 French centers is expected. The ability of Prostate Health Index to predict prostate cancer at biopsy will be evaluated in terms of intrinsic and extrinsic diagnostic performances including sensitivity, specificity, predictive values, diagnostic accuracy, area under receiver operating curves and decision curve analyses.

NCT ID: NCT03148795 Not yet recruiting - Prostate Cancer Clinical Trials

A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

Start date: May 2017
Phase: Phase 2
Study type: Interventional

The purpose of this international, phase 2, open-label, 2-arm, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).