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870 active trials for Prostate Cancer

Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy can fight prostate cancer by androgen deprivation. It is not yet known if neoadjuvant radiation therapy is a more effective therapy for high-risk prostate cancer. PURPOSE: Two-stage randomized trial to compare the effectiveness and safety of neoadjuvant radiotherapy and hormone therapy followed by radical prostatectomy in men with high-risk locally advanced prostate cancer

Start: July 2021

Improving Care After Inherited Cancer Testing

The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results. These interventions will be delivered to individuals with a documented pathogenic/likely pathogenic variant or variant of uncertain significance (VUS) in an inherited cancer gene.

Start: August 2021

18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

Start: May 2021

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

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.

Start: August 2016

Diffusion Basis Spectrum Imaging of the Prostate

Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.

Start: February 2020

Neoadjuvant SGLT2 Inhibition in High-Risk Localized Prostate Cancer

This is a study of the tolerability and safety of neoadjuvant dapagliflozin for patients with high-risk or very high risk prostatic adenocarcinoma prior to radical prostatectomy. The primary hypothesis is that four weeks of daily dapagliflozin prior to surgery is well-tolerated and safe to use in this patient population.

Start: April 2022

Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Background: Prostate cancer is the second leading cause of cancer death in 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.. PET/CT scan. Participants will get an injection of 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. Participantes will continue to have routine visits until two years after treatment is completed....

Start: July 2018

Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment

This study will use a population-based cohort design to study men with newly diagnosed low- and intermediate-risk prostate cancer at high-volume centers in Southern California (SCa) and New York State (NYS). Complications of contemporary treatments for prostate cancer and quality of life outcomes, such as general health, urinary, sexual, and bowel function, cancer anxiety, and treatment regret will be compared and tracked over the course of this study.

Start: May 2021

A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer

In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials. Main treatment period is completed and reported. Follow-up ongoing.

Start: April 2013

Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

The main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate (SCAP). Our study hypothesis is that SCAP constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy (EBRT).

Start: May 2021

Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients

This will be a confirmatory, prospective, open-label, single-arm, reader-blinded, multi-centre phase 3 study to assess the diagnostic accuracy and safety of Ferrotran®-enhanced MRI in comparison to unenhanced MRI in the detection of pelvic lymph node metastases in newly-diagnosed adult patients with prostate cancer and an intermediate to high risk for lymph node metastases, based on the D'Amico criteria.

Start: May 2020

Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Treatment With Docetaxel Followed by Enzalutamide

This is a prospective biomarker study of patients with metastatic castration-resistant prostate cancer (mCRPC) undergoing sequential treatment with docetaxel and enzalutamide. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study. The primary goal of this study is to evaluate the association of the AR-V7 status and androgen receptor (AR) gene alterations with PSA response to docetaxel and enzalutamide.

Start: September 2019

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.

Start: May 2021

A Study to Learn More About How Radium-223 Affects the Quality of Life of Colombian Patients With Prostate Cancer That Has Not Responded to Testosterone Lowering Treatment and Has Spread to the Bones, and to Better Understand Its Safety

The study drug, radium-223, gives off radiation that helps to kill cancer cells in the prostate. It is already available for patients to receive as a treatment for prostate cancer that has not responded to testosterone lowering treatment and has spread to the bones. This type of cancer is called metastatic castration-resistant prostate cancer, also called mCRPC. Sometimes, researchers continue studying an available treatment to learn more about how it affects patients' daily lives. In this study, the researchers want to learn more about how radium-223 affects the patients' ability to do their daily tasks. The patients in this study will already be receiving treatment with radium-223 as part of their routine care. The tests and measurements in this study will be done by the patients' own doctors. The researchers will collect information about the patients' treatment and results. The study will include patients with mCRPC who have at least 2 tumors in their bones. These patients will have recently started treatment with radium-223. The patients will have also had surgery or treatment to lower their testosterone levels. But, the treatment did not help their cancer. The study will include about 105 men in Colombia who are at least 18 years old. All of the patients will receive radium-223 through a needle put into the vein, also called an intravenous injection. They will visit their doctor's office up to 8 times during 28 weeks. At these visits, their doctors will ask how they are feeling and what medications they are taking, and will take blood samples. The doctors will also give the patients surveys about their physical, social, and emotional health and about the symptoms of their prostate cancer.

Start: July 2021

Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen deprivation therapy with goserelin and abiraterone with or without apalutamide prior to radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.

Start: January 2019

Docetaxel Ethanol-induced Symptoms; The Incidence and Risk Forecating Factor

To determine the incidence and risk factors of ethanol-induced symptoms, this multicenter, prospective, observational study is designed to include patients in Korea who are receiving chemotherapy with ethanol-containing docetaxel alone or in combination. Subjects who voluntarily provide written informed consent to provide information for this study and meet the inclusion/exclusion criteria will be given an enrollment number and will be followed during the observation period to collect study-related data in the Case Report Forms (CRFs) as predefined in the study protocol. Patients' decision to participate (or not) in this study will not affect their treatment (physician's prescriptions or diagnostic/therapeutic decisions).

Start: June 2020

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

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.

Start: August 2017

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Background: Immunotherapy drugs help the body to fight cancer. Scientists think that combining some of these drugs will make them work better than when used alone. This may be true for many types of cancer, including castration-resistant prostate cancer (CRPC). Objective: To test if the combination of the drugs BN-brachyury, M7824, N-803, and Epacadostat is safe and shrinks tumors. Eligibility: People ages 18 and older with CRPC or another metastatic cancer Design: Participants will be screened with: Medical history Physical exam CT or MRI scans Possible bone imaging Blood, urine, and heart tests Possible tumor biopsy Participants will be treated with a 2-, 3- or 4-drug combinations of the following study drugs in 2-week cycles: Participants will receive M7824 by IV once every 2 weeks. Participants will receive N-803 by injection once every 2 weeks. They will record any skin changes at the injection site in a diary. Participants will receive BN-brachyury as 4 injections to different limbs. They will get the first 3 doses 2 weeks apart. Then they will get doses every 4 weeks for 6 months, then every 3 months for 2 years, then every 6 months. Participants will take Epacadostat orally every 12 hours. They will keep a pill diary. Participants will have physical exams and blood and urine tests at the start of each cycle. They may have scans every 12 weeks. Participants will continue treatment until their disease gets worse or they cannot tolerate the side effects. Participants will have a follow-up visit 4-5 weeks after they stop treatment. They will have a physical exam and blood tests. They may be asked to return for scans every 3 months.

Start: May 2018

MRI for Assessing Prostate Cancer Response

Prostate cancer is one of most common cancers in America, affecting 1 in 6 men. External beam radiation therapy is one of the common methods to treat prostate cancer. Although radiotherapy is effective, side effects to the adjacent normal organs limit the therapeutic ratio. Those side effects are usually associated with the radiation damage of the normal tissue surrounding prostate, e.g. bladder, urethra and rectum etc. Both effectiveness and the side effects of radiation treatment are often accessed after whole course of radiotherapy, which makes the early intervention difficult. The current research project is a feasibility study of utilizing advanced magnetic resonance imaging (MRI) techniques to access radiotherapy treatment response of prostate cancer during and right after radiotherapy. Many advanced MRI techniques, e.g. spectroscopy (MRS), diffusion-weighted (DWI), dynamic contrast enhanced (DCE) perfusion weighted images, have been used in radiology departments for diagnostic purpose. This research project is to study the feasibility of using advanced MRI sequences to monitor tissue response during and after radiotherapy. The tissue changes revealed from MRI can provide physicians early information on possible tumor recurrence and normal tissue toxicity, therefore, the early intervention may be possible to spare normal tissue and cure the patient. The project is designed to combine several different advanced MRI imaging techniques systematically to study tissue changes during radiotherapy, which has not been seen elsewhere to date. Another important goal of this research project is to study the feasibility of associating functional MRI with radiation treatment dose distribution. Tissue response during radiation treatment depends on dose. The functional MRI can provide more information than simple anatomic information. Mapping the functional MRI spatially and associating them with 3D dose distribution in radiation treatment planning system is one important step to quantitative assess the relationship between radiation treatment and tissue changes due to the radiation.

Start: November 2012

Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors

This clinical trial will evaluate the adherence, usefulness, satisfaction and effect size for the Sleep Coach app as an intervention for insomnia in 30 adult post-treatment cancer survivors.

Start: May 2021