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Prostatic Neoplasms clinical trials

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NCT ID: NCT02294461 Active, not recruiting - Clinical trials for Progressive Metastatic Prostate Cancer

An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants

Start date: April 23, 2014
Phase: Phase 3
Study type: Interventional

Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.

NCT ID: NCT02278185 Active, not recruiting - Clinical trials for Adenocarcinoma of the Prostate

Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer

Start date: November 11, 2015
Phase: Phase 2
Study type: Interventional

This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies have shown that patients with prostate cancer, who have been treated with standard medical therapy that lowers testosterone levels, have an increased risk of these changes. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells instead of lowering testosterone levels. It is not yet known whether prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who receive standard androgen deprivation therapy.

NCT ID: NCT02274779 Active, not recruiting - Prostate Cancer Clinical Trials

Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer

OLIGOPELVIS
Start date: August 20, 2014
Phase: Phase 2
Study type: Interventional

There is an increasing number of reports describing the existence of a proportion of prostate cancer patients who present with a reduced number of metastases (<5 lesions) at relapse. This oligometastatic status has also been recognized in other tumor types such as melanoma, soft tissue sarcoma, liver, lung, and breast cancer, and has influenced the management of these malignancies in that a more radical treatment such as surgical resection has been employed. Positron Emission Tomography-Computed Tomography (PET-CT) studies with tracers such as choline or acetate are reliable tools to help with the diagnosis of oligometastatic disease after biochemical treatment failure in prostate cancer. An aggressive treatment combining androgen depriving therapy (ADT) and and high-dose irradiation to the oligometastatic lesions, as detected by PET-CT, may be proposed for these oligometastatic patients. Such a treatment strategy may hypothetically succeed to prolong the failure-free interval between two consecutive ADT courses, or even cure selected patients with limited metastatic burden. In this study the investigators plan to assess biochemical or clinical relapse-free survival at 2 years of prostate cancer with 1-5 oligometastases treated concomitantly with high-dose conformal Radiation Therapy and LH-RH agonists.

NCT ID: NCT02266745 Active, not recruiting - Clinical trials for Advanced Solid Tumors

A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

Start date: July 2014
Phase: Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase is complete and no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).

NCT ID: NCT02257736 Active, not recruiting - Prostatic Neoplasms Clinical Trials

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Start date: November 26, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).

NCT ID: NCT02255890 Active, not recruiting - Prostate Cancer Clinical Trials

Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device

Start date: November 2014
Phase:
Study type: Observational [Patient Registry]

The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline. Secondary objectives are to establish which indications lead to treatment with IRE Nanoknife® setting and safety assessment measured by number of complications and adverse events.

NCT ID: NCT02254785 Active, not recruiting - Clinical trials for Metastatic Castration-Resistant Prostatic Cancer

Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer

Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess and compare the clinical benefit rate in patients with metastatic castrate-resistant prostate cancer and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to determine which treatment is most active in this population. Clinical benefit rate is defined as PSA or measurable radiological response of any duration or stable disease for > or equal to 12 weeks, in the absence of other indicators of progression. There is option to cross-over onto the other arm if the patient progresses.

NCT ID: NCT02243033 Active, not recruiting - Prostate Cancer Clinical Trials

Phase II Laser Focal Therapy of Prostate Cancer

LITT or FLA
Start date: May 2016
Phase:
Study type: Observational

Target recruitment: 1000 subjects. The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize that laser focal therapy can be used to achieve oncologic control in carefully selected patients. MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses light to heat a target area to try to destroy cancerous cells. The laser system that will be used is called the Visualase® Thermal Therapy System. This system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers. However; this study is the first time this system has been studied for use in the treatment of prostate cancer with a trans-rectal approach. MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.

NCT ID: NCT02242773 Active, not recruiting - Prostate Cancer Clinical Trials

MRI Based Active Selection for Treatment Trial

MAST
Start date: November 12, 2014
Phase: N/A
Study type: Interventional

The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would be likely to require treatment earlier.

NCT ID: NCT02233725 Active, not recruiting - Prostatic Neoplasms Clinical Trials

MRI / Ultrasound Fusion With Contrast-Enhanced Ultrasound Guidance

Start date: July 2014
Phase: Phase 1
Study type: Interventional

Prostate cancer is the most common cancer in men. It is most often detected by an abnormal digital rectal exam or an elevated Prostate-Specific Antigen -determine by a blood test. When it is suspected that someone may have prostate cancer, a biopsy is ordered. This biopsy is performed by the Radiologist with ultrasound guidance through the rectum. In some patients, a Magnetic Resonance Imaging (MRI) scan of the prostate may be ordered to further evaluate the prostate. In some situations, the MRI and Ultrasound images will be fused (digitally merged) together during the ultrasound procedure to help localize the questionable lesions. Recent research has used an additional component known as a contrast agent - an intravenously injected inert substance - which is identifiable by ultrasound. This inert substance is more obvious in areas of increased blood flow, which is a common finding in cancerous lesions. In this research project, we would like to determine whether the use of contrast-enhanced ultrasound is beneficial in improving accuracy of the biopsies taken and the relative correlation to the MRI/ Ultrasound-fused images.