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Prostate Cancer clinical trials

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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: 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.

NCT ID: NCT02488096 Completed - Prostate Cancer Clinical Trials

Improving Prostate Cancer Detection Using MRI-Targeted TRUS-Guided Biopsy

Start date: December 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies.

NCT ID: NCT02485964 Completed - Prostate Cancer Clinical Trials

A Pilot Study to Assess the Immunogenicity of Candidate PSA Peptides for a Prostate Cancer Vaccine

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

To measure antigen-specific interferon-secretion by enzyme-linked immunospot (ELISPOT) assay, which measures antigen-specific interferon-secretion.

NCT ID: NCT02485379 Completed - Prostate Cancer Clinical Trials

Assessment of Prostate MRI Before Prostate Biopsies

MRI-FIRST01
Start date: July 2015
Phase: N/A
Study type: Interventional

Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific Antigen (PSA) level, it is currently recommended to perform "blinded" systematically distributed biopsies with 10-18 samples obtained from predefined locations in the gland. These so-called systematic biopsies (SB) may lead to improper patient management by (i) missing clinically significant cancer, especially in the anterior half of the gland that tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer foci that may result in overtreatments, (iii) undersampling the tumor foci and thus underestimating their volume and aggressiveness. Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the aggressiveness of detected cancers than SB. However, these monocenter studies only provide low-level evidence and three recent independent reviews of literature concluded that there was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared to SB. This is particularly important since many academic and private centers in France already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that this approach becomes the norm without being properly evaluated and it is crucial and urgent to perform a controlled multicentric study to provide high-level evidence as to whether mp-MRI should or should not be obtained before prostate biopsy. One controlled multicentric study has been published recently in which SB and TB had been obtained by two different operators in 95 patients. TB yielded a significantly higher detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients with negative mp-MRI were not included. Research hypotheses: There is currently no robust multicenter trial comparing prostate TB based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre prospective trial comparing the results of SB and TB performed in the same patients by two independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a significantly higher percentage of patients than SB. Main objective: To compare the percentage of patients with "clinically significant cancer" (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.

NCT ID: NCT02479945 Completed - Prostate Cancer Clinical Trials

Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer

Start date: January 2012
Phase: N/A
Study type: Interventional

The investigators will compare tumor marker levels, including PSA, in samples taken from a peripheral upper limb vein and the internal iliac veins. These will be collected from patients who are scheduled for prostatectomy as part of their standard of care for prostate cancer. A selective internal iliac vein sampling procedure will be performed in Interventional Radiology. Venous samples will be correlated with prostatectomy specimens. The aim is to predict the side of the prostate containing tumor.

NCT ID: NCT02477137 Completed - Prostate Cancer Clinical Trials

Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer

PhONEME
Start date: July 20, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of an interactive ICT-platform for use in a smartphone or tablet in patients treated with radiotherapy for prostate cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report symptoms in an application which provides self-care advice and instant access to professionals.