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Prostatic Neoplasms clinical trials

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NCT ID: NCT03284151 Active, not recruiting - Prostate Cancer Clinical Trials

Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma

Start date: January 2015
Phase:
Study type: Observational [Patient Registry]

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

NCT ID: NCT03274687 Active, not recruiting - Clinical trials for Prostate Adenocarcinoma

Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer

Start date: July 28, 2017
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.

NCT ID: NCT03269422 Active, not recruiting - Prostate Cancer Clinical Trials

Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)

Start date: August 28, 2017
Phase: Phase 1
Study type: Interventional

The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.

NCT ID: NCT03263650 Active, not recruiting - Prostate Carcinoma Clinical Trials

Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC

Start date: October 3, 2017
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if olaparib, when given after treatment with cabazitaxel, carboplatin, and prednisone, can help to control aggressive variant prostate cancer (AVPC). The safety of these drugs will also be studied. This is an investigational study. Cabazitaxel and carboplatin are FDA approved and commercially available for the treatment of certain types of prostate cancer. Prednisone is FDA-approved and commercially available as a corticosteroid. Olaparib is FDA approved and commercially available for the treatment of certain types of ovarian cancer. The combination of cabazitaxel and carboplatin followed by olaparib in this study is investigational. The study doctor can describe how the study drugs are designed to work. Up to 96 participants will be enrolled on this study. All will take part at MD Anderson.

NCT ID: NCT03261271 Active, not recruiting - Obesity Clinical Trials

Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy

WARRIOR
Start date: August 28, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.

NCT ID: NCT03255135 Active, not recruiting - Prostate Cancer Clinical Trials

Initial Experience in Brazilian Single Center With High Intensity Focalized Ultrasound (HIFU) Prostate Cancer Therapy: Morbidity, Oncological and Functional Outcomes.

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

Prostate cancer (PCa) is the most prevalent non cutaneous cancer in occidental countries. In Brazil incidence was about sixty thousand new cases in 2016 and occupied second place as all cancer mortality, just behind lung cancer. Literature shows than younger patients tend to have more aggressive tumors rising cancer specific mortality scores. Main risk factors are age, life style (sedentary, high meat and fat intake) and family history (gene inheritance). Besides vast advances in precocious tumors detection, challenges remain in the definition of the biological status of the tumor, which is highly variable and full of prognostic implications. PCa heterogeneity is demonstrated by the uncertain natural history, varying from indolent lesion to aggressive metastatic and fast progression cancer resistant to conventional therapies. In an actual treatment scenario, prognostic identification is the cornerstone of daily practice treatment considering the natural history variability cited before and the discrepancy of long term slow growth (studies estimate eight to sixteen years of tumor growth to achieve metastatic disease) to high grade aggressive cancer. Considering all this background and taking in account the indolent evolution of low risk PCa new therapies emerge with promising outcomes. High-Intensity Focused Ultrasound (HIFU) have to be highlighted due to easy operation, good oncologic results and low complication profile. The method is based on real-time imaging guided high intensity ultrasound (US) causing overheat and cavitation in the focused tissue. Applied since 90's, mainly in German and French groups, initially programmed to treat hole gland preserving only urinary sphincter and bladder neck, showed recently some data on 1700 patients, 5 years biochemical recurrence free survival of 80% and best results including morbidity profile in low risk, low prostate volume and in the group with previous trans urethral prostate resection (TURP). This results are very similar to other radical treatment options with median follow up of 8 years, cancer specific survival 98% and metastasis free survival of 95% If local recurrence was identified another HIFU ablation or even radical treatment achieved good results in local control with acceptable morbidity profile. Focal treatment is a new entity in PCa therapy. One randomized trial compared focal treatment to active surveillance in 513 mans with PCa diagnosis. With a 24 month follow-up progression-free ratios (28% x 58%) and positive control prostate biopsy ratios (14% x 49%) were fairly superior in treatment group. This exiting novel data turns urological oncology paths to the new era of minimally harmful therapy with targeted focused procedure. At our knowledge there is no high evidence clinical trial comparing HIFU to active surveillance. The objective of this study is to evaluate prospectively the initial experience with 50 patients submitted to HIFU therapy for low risk prostate cancer in Brazilian single center considering the following aspects: One year of treatment prostate biopsy positiveness; Biochemical recurrence free survival using Phoenix and Stuttgart criteria in one year; Sexual function using IIEF-5 questionnaire and the usage of 5-phosphodiesterase inhibitors (5-PDI); Urinary symptoms using EPIC and IPSS questionnaires and free urinary flow; Quality of life based on SF-36 questionnaire evaluation; Post procedure morbidity using Clavien-Dindo classification.

NCT ID: NCT03254420 Active, not recruiting - Prostate Cancer Clinical Trials

Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.

RCMIGI
Start date: August 30, 2016
Phase: N/A
Study type: Interventional

The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. So the exact position and movement of the prostate can be determined during radiation therapy treatment. The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.

NCT ID: NCT03253978 Active, not recruiting - Prostate Cancer Clinical Trials

SPORT High-Risk Trial Evaluating SABR in Prostate Cancer

SPORT
Start date: January 18, 2016
Phase: N/A
Study type: Interventional

The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the effect of SABR on levels of markers of radiation exposure and bowel damage, along with other potential markers of outcome and side effects. Quality of life and any side effects that develop during and after treatment will also be assessed.

NCT ID: NCT03253744 Active, not recruiting - Prostate Cancer Clinical Trials

Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Start date: July 5, 2018
Phase: Phase 1
Study type: Interventional

Background: Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT). Objective: To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation. Eligibility: Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease. Design: Participants will be screened with blood tests, physical exam, and medical history. They may also have: Magnetic resonance imaging (MRI) scan of the prostate. Positron emission tomography (PET)/computed tomography (CT) scan. Participants will get an injection of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) for the PET scan. They will lie very still on their back on the scanner table. Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation. About 2 weeks later, participants will have a radiation treatment planning CT scan. Participants will answer questions about their urine function, bowel function, erectile function, and mood. Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks. Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires. Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated. Participants will continue to have routine visits until two years after treatment is completed....

NCT ID: NCT03246347 Active, not recruiting - Prostate Cancer Clinical Trials

A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer

Start date: August 23, 2017
Phase: Phase 2
Study type: Interventional

This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.