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Prostatic Neoplasms clinical trials

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NCT ID: NCT01546623 Completed - Prostate Cancer Clinical Trials

A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously treated with hormonal therapy.

NCT ID: NCT01545154 Completed - Prostate Cancer Clinical Trials

The Use of Transperineal Ultrasound for Radiation Therapy Treatment Planning and Image Guidance in the Treatment of Prostate Cancer

Start date: February 2012
Phase: N/A
Study type: Observational

This study is being done to find out if transperineal ultrasound (TPUS) can help define the prostate gland for radiation treatment planning and improve upon current methods of image guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are lying on their back in the position they will receive their treatment. Image-guidance is required for the treatment of prostate cancer because the prostate shifts position depending on how full the bladder and rectum are. Image-guided radiation therapy has been done at Fletcher Allen Health Care for approximately three years. Most commonly, transabdominal ultrasound images are obtained every day and compared to an ultrasound that was done on the day of treatment planning. Adjustments in radiation field position can be done on a daily basis by comparing these images. Transperineal ultrasound has never been used for image-guidance. The investigators completed an earlier study and have developed a TPUS device and process that allow us to get clear ultrasound pictures of the prostate gland. The TPUS has three potential advantages over the transabdominal method the investigators currently use: 1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get clearer images, however it is difficult for some men with prostate cancer to comfortably keep a full bladder. It is also particularly difficult to get good images in larger men who have long distances from the skin surface to the prostate gland. TPUS is not dependent on a man having a full bladder and should be less dependent on the size of the man. 2. TPUS images and the planning CT images can be acquired simultaneously. This is not possible with the abdominal probe because it gets in the way of the CT machine. Simultaneous imaging eliminates the possibility of the prostate gland shifting positions during the time between imaging studies. 3. TPUS can be in place and acquire images during patient treatment (the abdominal probe gets in the way of the treatment machine) and may in the future allow us to watch the prostate gland during treatment. If the investigators discover that they can accurately view the prostate gland in real time, TPUS may ultimately allow us to treat even smaller radiation fields and possibly decrease the risk of radiation complications. Patients in this study will be treated for their prostate cancer with the standard image guidance techniques used at Fletcher Allen Health Care: transabdominal ultrasound and/or X-ray imaging of gold marker seeds that have been placed the prostate gland. In addition to standard care, all men in this study will have TPUS and CT scans done a total of four times over 12 weeks to compare these methods of prostate localization over the course of radiation treatments. Some men may choose to take part in an additional study that will also include MRI of the pelvis to compare with the TPUS and CT. Because the prostate gland can be more clearly defined on MRI, some institutions (not Fletcher Allen) routinely have patients with prostate cancer get MRI scans for treatment planning. This has not been proven to improve the care of men with prostate cancer and it is possible that TPUS will provide similarly clear images. The potential advantages to TPUS imaging for prostate localization over MRI include the fact that it is done at the same time as the CT for treatment planning (so eliminates the possibility of movement of the prostate gland from the time of the MRI to the time of the CT) and can be done at a much lower cost.

NCT ID: NCT01543776 Completed - Clinical trials for Stage IV Prostate Cancer

Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer

Start date: January 2012
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.

NCT ID: NCT01543659 Completed - Prostate Cancer Clinical Trials

Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer

Start date: February 21, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to define the safety and accuracy of 89Zr-DFO-huJ591 PET scans. By improving our ability to find cancer cells, the investigators hope to be able to improve treatment for patients in the future. The study doctors want to determine whether a new kind of scan, called a 89Zr-DFO-huJ591 PET scan, can specifically see prostate cancer that has spread to other parts of the body, especially the bones. The study doctors will also look at how the 89Zr-DFO-huJ591 reacts with the body and how long it stays in the body. The investigators will also ask the patient to have a biopsy performed. The study doctors will compare the findings the investigators see on the scans with findings on the optional tissue biopsy. Finally, the investigators will compare the pictures from a 89Zr-DFO-huJ591 PET scan with those of a standard PET scan (called FDG PET) and standard CT scans or magnetic resonance (MRI) scans or bone scans, depending on which standard scans the doctor has ordered. PET scanning uses a small amount of radiation attached to a molecule that is taken up by the cancer. In this trial, the patient will undergo two types of PET scans. One uses FDG. FDG is a standard tracer for PET scans. The patient will also undergo another type of PET scan that is experimental. This experimental PET uses a radioactive protein called J591. The radiation source is a type of metal called zirconium-89 (89Zr). The whole tracer, J591 plus the 89Zr, is abbreviated as 89Zr-DFO-huJ591. This tracer is what is being studied. The tracer used in a scan should find where the cancer is in the body.

NCT ID: NCT01541007 Completed - Clinical trials for Metastatic Castration Resistant Prostate Cancer

A Study Looking at Novel Scheduling of Cabazitaxel for Patients With Metastatic Prostate Cancer

ConCab
Start date: April 2012
Phase: Phase 2
Study type: Interventional

Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4 patients treated with Cabazitaxel in this study required dose reductions or dose delays or stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see if we can improve tolerability so that patients will receive a higher percentage of the treatment as planned.

NCT ID: NCT01540994 Completed - Prostatic Neoplasm Clinical Trials

Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Start date: January 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.

NCT ID: NCT01540071 Completed - Clinical trials for Castration Resistant Prostate Cancer

Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer.

NCT ID: NCT01538628 Completed - Prostate Cancer Clinical Trials

SpaceOAR System Pivotal Study

Start date: January 2012
Phase: Phase 3
Study type: Interventional

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)

NCT ID: NCT01535898 Completed - Prostate Cancer Clinical Trials

Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Head and Neck, and Prostate Cancers

Start date: February 2012
Phase: N/A
Study type: Observational

Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer or prostate cancer. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.

NCT ID: NCT01535040 Completed - Breast Cancer Clinical Trials

Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Start date: August 1, 2012
Phase: Phase 2
Study type: Interventional

RATIONALE: Memantine hydrochloride may help people stop smoking by decreasing the symptoms of nicotine withdrawal. PURPOSE: This randomized, pilot phase II trial studies how effective memantine hydrochloride works compared to placebo in helping cancer survivors stop smoking.