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Prostatic Neoplasms clinical trials

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NCT ID: NCT02440308 Active, not recruiting - Prostate Carcinoma Clinical Trials

68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

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

This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin positron emission tomography (PET)/magnetic resonance imaging (MRI) in imaging patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

NCT ID: NCT02435472 Active, not recruiting - Clinical trials for Localized Prostate Cancer

Active Surveillance Exercise Clinical Trial

ASX
Start date: June 21, 2016
Phase: N/A
Study type: Interventional

This phase 2, open-label, dual-center, two-arm randomized controlled trial (RCT) investigates the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance). Prostate genomic signatures represent the functional activity of all genes in the genome and are converted into genomic risk scores which correspond to the probability of a progression event (chance of having more aggressive disease). A structured exercise program may alter the genomic risk score and improve prediction of aggressive disease.

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: NCT02420977 Active, not recruiting - Clinical trials for Advanced Prostate Cancer

Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer

Start date: December 6, 2018
Phase: Early Phase 1
Study type: Interventional

This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.

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: NCT02410291 Active, not recruiting - Clinical trials for Latent Cancer (Prostate)

Impact on Instructional Video on Patients' Compliance With Preparation During CT Planning for Prostate Cancer

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

Rectal toxicity limits dose escalated intensity modulated radiotherapy (IMRT) for prostate cancer. The dose volume constraints that predict for rectal toxicity require minimizing prostate motion and rectum and bladder filling of IMRT .5-15 . The volumetric changes and internal organ motion during prostate IMRT increases risk of PSA failure in patients with large rectums at the planning CT scans. Patient preparation for IMRT planning is crucial .The literature is limited regarding the effectiveness of educational intervention with behavioral reinforcement for patients, and a gap if exists literacy level is considered. Patients often cannot comprehend verbal or written instructions and have difficulties following through with recommended regimens.23 Using multimedia such as Internet, audio-visual media such as DVD and even the telephone can enhance patients' knowledge and understanding about importance of preparation for IMRT for prostate ca. Thomas's study showed that in patients undergoing radiotherapy and chemotherapy, the video group had lower anxiety scores compared with the non video group. At SOCC patients have been provided with verbal information about bladder and rectum preparation for prostate planning CT scan and IMRT. Patients should have a "fullish" bladder and empty rectum at the time of CT simulation. If the rectal diameter is > 4cm, the patient will be asked to empty his stool/gas and re-scanned. The 3- months review of patients preparedness for prostate IMRT showed that only 13/55 patients were adequately prepared but 42/55 (76%) of patients needed to be re-scanned due to inadequate bladder (21/42, 50%) or rectum filling 28/42, 67%) . Also, 2/13 (15%) patients were still not prepared at the second resimulation despite that they received a phone call with the instructions. The investigators plan to investigate if a multimedia education strategy will decrease costly resimulation rate for patients with prostate cancer.

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: NCT02362620 Active, not recruiting - Clinical trials for Advanced Prostate Cancer

PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.

PROSTAC
Start date: May 2014
Phase:
Study type: Observational

PROSTAC is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with docetaxel or cabazitaxel

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).