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Prostate Cancer clinical trials

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NCT ID: NCT02473003 Active, not recruiting - Breast Cancer Clinical Trials

Physical Training and Cancer-a Multicenter Clinical Trial

Phys-Can
Start date: March 2015
Phase: N/A
Study type: Interventional

Excessive tiredness (fatigue) is a common problem in cancer patients and can affect quality of life negatively. There is limited knowledge about the physical mechanisms that cause fatigue, and there is no medical treatment. Physical activity can reduce the inconvenience, but the investigators need to learn more about the type and intensity of exercise that works the best as well as how to motivate patients to exercise. The overall aim, is to evaluate the efficacy and cost-effectiveness of individually tailored high (H) and low/medium (LM) intensity physical training, with or without behavioural medicine (BM) support strategies, during adjuvant oncological treatment on; Cancer Related Fatigue (CRF),Quality of Life (QoL), mood disturbance, adherence to the cancer treatment, adverse effects, disease outcome, return to a daily life after completed treatment and return to work. The investigators will also describe changes in inflammatory markers and cytokines related to physical training and gene expressions following training to investigate whether these serve as mediators for the effects of physical training on CRF and QoL. This will be evaluated in newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at three different centres in Sweden; Uppsala, Lund/Malmö and Linköping. A 2x2 factorial design will be used, 600 patients will be randomised to H, H+BM, LM or LM+BM. Patients will train two times per week during 6 months. This project will give; new knowledge about aspects for individuals to gain improved well-being and quality of life, facilitated return to work, and possibly reduced risk of cancer recurrence. This in turn would result in lower burden on the health care system, reduced societal costs and have a positive impact on public health. Implementation of the results into clinical practice will be facilitated by the close collaboration between researchers and clinicians, and the fact that the study is performed in clinical settings.

NCT ID: NCT02460861 Active, not recruiting - Prostate Cancer Clinical Trials

Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy

iPROLOGX
Start date: November 2011
Phase: N/A
Study type: Interventional

This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA). The prostate-cancer-negative control group with bladder cancer.

NCT ID: NCT02454543 Active, not recruiting - Prostate Cancer Clinical Trials

Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases

g-RAMPP
Start date: May 2015
Phase: N/A
Study type: Interventional

The aim of the study is to investigate, the effect of radical prostatectomy with extended lymphadenectomy on cancer-specific survival, time to castration-resistance, time to progression and quality of life in patients with a limited bone metastatic prostate cancer. In addition the influence of patient- and disease-related factors on clinical outcome (prognostic effect) and on the comparison therapy (predictive effect) will be examined. Amendment05: Due to the slow tumor biology of prostate cancer, the follow-up period of 5 years is not sufficient to reach the primary endpoint of the study. For this reason, the follow-up is extended for a further 5 years with 2 visits per year.

NCT ID: NCT02452008 Active, not recruiting - Prostate Cancer Clinical Trials

Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Start date: May 3, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).

NCT ID: NCT02430480 Active, not recruiting - Prostate Cancer Clinical Trials

Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer

Start date: June 3, 2015
Phase: Phase 2
Study type: Interventional

Background: - There are several ways to treat prostate cancer. Researchers want to see how well a certain kind of imaging helps detect prostate cancer. They also want to see if a particular drug combination used before surgery will benefit people with prostate cancer that hasn't spread in the body (non-metastatic). The combination will be androgen deprivation therapy and enzalutamide. - The combination of androgen deprivation therapy and enzalutamide has been shown to make patients with advanced (metastatic disease) live longer. The investigators want to see if using it earlier can increase cure rate of surgery and identify genetic or molecular characteristics that are associated with better outcomes. Objectives: - To develop better ways of detecting prostate cancer before and after pre-operative treatment. Eligibility: - Men at least 18 years old with non-metastatic prostate cancer. They must be candidates for a radical prostatectomy. Design: - Participants will be screened with medical history, physical exam, and blood tests. They will have scans and X-rays. - Before starting the study drugs, participants will have: - Vital signs taken, medical history, and blood tests. - Electrocardiogram (ECG) heart test, with patches stuck on the skin. - Small piece of tumor removed (biopsy) using image guidance from magnetic resonance imaging (MRI) and ultrasound. - 3T multi-parametric magnetic resonance imaging (mpMRI). Participants will lie on a table that slides into a metal cylinder. A probe will be inserted in the rectum. They will be in the scanner for about 60 minutes, lying still. The scanner makes loud knocking sounds. Participants will get earplugs. - Participants will take the 2 study drugs for 6 months. - Enzalutamide is taken as 4 pills once a day. - Androgen deprivation therapy is given by injection 2 times over 6 months. - During these 6 months, participants will visit the clinic monthly. They will have physical exam, vital signs, and blood drawn. - After finishing the study drugs, participants will have another 3T mpMRI. Then they will have prostate removal surgery.

NCT ID: NCT02425592 Active, not recruiting - Prostate Cancer Clinical Trials

Active Surveillance in Prostate Cancer, Imaging to Detect Radiographic Progression as an Endpoint (ASPIRE)

ASPIRE
Start date: April 2015
Phase:
Study type: Observational

The objective in this study is to determine if MRI-identified progression can decrease frequency or need for repeated prostate biopsy in men on active surveillance (AS). Our hypothesis is that MRI alone is adequate to detect progression of prostate cancer in men on active surveillance (AS) after a MRI-US fusion prostate biopsy.

NCT ID: NCT02415621 Active, not recruiting - Prostate Cancer Clinical Trials

Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer

Start date: April 13, 2015
Phase: Early Phase 1
Study type: Interventional

Abiraterone is approved in the United States by the U.S. Food and Drug Administration (FDA) to treat metastatic prostate cancer at 1000 mg daily. The purpose of this study is to find out if an on and off schedule of taking abiraterone would prolong the participant's cancer's response to this drug and maintain their functionality to perform their daily activities.

NCT ID: NCT02408497 Active, not recruiting - Prostate Cancer Clinical Trials

Use of Non-invasive 4D Ultrasound Clarity System in Prostate IMRT/RapidArc Therapy

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

A single arm phase II study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT.

NCT ID: NCT02366494 Active, not recruiting - Prostate Cancer Clinical Trials

Micro RNAs to Predict Response to Androgen Deprivation Therapy

Start date: April 29, 2015
Phase:
Study type: Observational

Identify exosomal micro RNA that predict responses to ADT

NCT ID: NCT02353819 Active, not recruiting - Prostate Cancer Clinical Trials

Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets For High Risk Prostate Cancer

Start date: October 2015
Phase: Phase 1
Study type: Interventional

Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information and high speed Graphics Processing Unit based computation treatment planning systems. We also plan to determine the safety of treatment to the prostate. Health-related quality of life will be measured as part of current clinical practice. - Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal using 90 day acute toxicity endpoint - Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal region at each treatment fraction by using cone-beam CT (CBCT) information and high speed GPU based computation treatment planning systems - Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate - Determine the feasibility and safety of temporal enhanced ultrasound for prostate lesion tracking during radiation therapy - To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS), distant metastasis (DM) free survival, and overall survival (OS) - Health-related quality of life (HRQOL) will be measured as part of current clinical practice Patients in each dose cohort will all be treated as a single group for dose escalation. There will be two levels of dose escalation-to prostate lesions and to pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences. The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will receive an additional 0.5Gy per treatment (total of 2.5Gy per escalation).