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Prostate Cancer clinical trials

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NCT ID: NCT02512835 Completed - Breast Cancer Clinical Trials

Understanding the Value of Community Vital Signs in Primary Care

Start date: October 2015
Phase: N/A
Study type: Observational

Social determinants of health (e.g. the income, education, and environment of patients) may exert greater influence on health outcomes than traditional clinical factors (e.g. lab results, diagnoses, and family history). Calls for integrating primary care and public health are therefore increasing, but merging these domains of care is logistically difficult. Research is lacking on the incremental benefit of adding public health data at the practice level-- in improving either health outcomes or care delivery. This proof of concept pilot will merge data from electronic health records (EHRs) with community vital signs, a set of metrics that describes key community resources that affect health. The investigators will identify resource poor communities, or cold spots, based on four variables (education, poverty, life expectancy, and access to healthy foods) at the census tract level - referred to as a community vital sign. The hypothesis is that patients coming from cold spots are more likely to have worse health outcomes and that clinicians will deliver better care if they know a patient's community context and his/her specific social needs. This study will involve 12 primary care practices in Northern Virginia that care for more than 170,000 patients. Patient addresses will be geocoded for each practice and determine which patients reside in cold spots for each community vital sign. The variation for each community vital sign for each practice's patients will be calculated and a bivariate and regression analyses will be used to determine whether coming from a cold spot is associated with worse clinical quality metrics. 15 clinicians will be alerted when they see a patient from a cold spot, patients will complete a social needs survey, and clinicians will prospectively document through surveys whether such knowledge affects interpersonal interactions (such as time spent with patients and the use of clearer language) or clinical management (such as referrals to care coordination or community resources). By pragmatically integrating community vital signs into care, this innovative proposal will seek to understand which community data clinicians value, how these data might influence care, and how best to incorporate these data into clinical and population care.

NCT ID: NCT02512185 Completed - Prostate Cancer Clinical Trials

Towards Optimal Prescription of Chemotherapy in Prostate Cancer

TOPCOP
Start date: July 2015
Phase:
Study type: Observational

This study will examine the impact of modern treatments for metastatic Castrate Resistant Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function, objective physical function, and falls. Additionally, the investigators study whether frailty is associated with worse outcomes, and whether it is possible to predict the risk of severe chemotherapy toxicity in older men.

NCT ID: NCT02512120 Withdrawn - Prostate Cancer Clinical Trials

Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation

VCVAFVCV
Start date: August 2015
Phase: N/A
Study type: Interventional

Volume controlled ventilation(VCV) is a most common used ventilation mode during general anesthesia. But VCV can cause high airway peak pressure when patient under steep Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure and improve dynamic compliance. We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.

NCT ID: NCT02511665 Not yet recruiting - Prostate Cancer Clinical Trials

Metformin And Longevity

METAL
Start date: July 2015
Phase: Phase 4
Study type: Interventional

This is a randomized, placebo-controlled, double-blind, window of opportunity study investigating the biological mechanism of metformin in prostate cancer.

NCT ID: NCT02507427 Completed - Prostate Cancer Clinical Trials

Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)

Start date: July 26, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.

NCT ID: NCT02503748 Completed - Prostate Cancer Clinical Trials

Prostate Cancer E-Health-Tutorial

PROCET
Start date: July 2015
Phase: N/A
Study type: Interventional

In a participatory process involving urologists and former patients, the project team has developed an online information system ("tutorial") for patients with localized prostate cancer. In this field test, relevant outcomes are measured and the tutorial will be tested for its clinical applicability.

NCT ID: NCT02499848 Completed - Prostate Cancer Clinical Trials

Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer

Start date: July 2015
Phase: Phase 2
Study type: Interventional

To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.

NCT ID: NCT02499497 Completed - Prostate Cancer Clinical Trials

A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

Start date: February 29, 2016
Phase: Phase 2
Study type: Interventional

This research study is studying the use of a targeted therapy called LY SARM, which is an investigational drug from a new class of molecules called Selective Androgen Receptor Modulators (SARMs) as a possible improvement in quality of life for participants who have undergone radical prostatectomy. Androgens are a group of hormones that play a role in male traits and reproductive activity. The names of the study interventions involved in this study are: - LY2452473

NCT ID: NCT02497638 Withdrawn - Prostate Cancer Clinical Trials

LIpitor and biGuanide to Androgen Delay Trial

LIGAND
Start date: December 2021
Phase: Phase 2
Study type: Interventional

This study is a randomized trial examining the administration of a combination of biguanide metformin and atorvastatin ("Lipitor") to men who are experiencing rising prostate-specific antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).

NCT ID: NCT02494921 Completed - Prostate Cancer Clinical Trials

LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC

Start date: November 20, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral daily doses in patients with metastatic castrate resistant prostate cancer (mCRPC) with prior resistance to abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination at the first dose level (dose level I), an alternative dosing schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week dosing schedule. The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the efficacy and further define the safety of the treatment combination. Patients will be treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there is no evidence of radiographic or clinical disease progression after 9 cycles of protocol therapy, patients may continue on single agent maintenance ribociclib until the time of disease progression. Patients will have the option of starting maintenance ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib used during maintenance will be the same dose as that immediately preceding cessation of docetaxel treatment.