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870 active trials for Prostate Cancer

Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis

Background: - Some genes may be associated with a greater chance of side effects during cancer treatment. These genes may also make certain treatments less effective. Researchers want to collect blood or cheek swab samples from people having cancer treatment to study these genes. Objectives: - To obtain a blood or cheek swab sample to study genetic differences that may affect cancer treatment. Eligibility: - Individuals with cancer who are being treated at the National Cancer Institute. Design: Participants will provide a blood sample for study. Participants who have blood-based cancer, such as leukemia, will provide a cheek swab sample. If the blood or cheek swab sample does not have enough genetic material for analysis, an additional sample may be collected.

Start: May 2012

Integrated Cancer Repository for Cancer Research

The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.

Start: November 2013

Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy

Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been identified, including low intratumor expression of antigens and elevated expression of inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is capable of delivering high, conformal radiation doses (>8 Gy) of tumor ablative radiation may be an effective means of conditioning a tumor bed to a state favorable to the initiation of robust antitumoral immune responses.

Start: January 2013

Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer

Prostate cancer is the most common cancer in men and the second leading cause of cancer death in men. The purpose of this research study is to compare prostate cancers treated with hormone therapy versus prostate cancers treated with hormone therapy plus drugs that directly target cancer cells.

Start: September 2014

Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)

This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. The investigators have found that T cells modified in this way were able to cure a cancer similar to Chronic Lymphocytic Leukemia in mice. However, this is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.

Start: June 2010

Prostate Cancer Upgrading Reference Set

Research repository designed to establish prostate cancer upgrading reference set and development of a risk prediction tool. Repository will include clinical information and biologics on a cohort of 240 men, to predict presence of high grade cancer at time of prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time of biopsy.

Start: August 2014

Trial of Modifications to Radical Prostatectomy

This study aims to determine how different ways of performing prostate cancer surgery affect patient outcomes, such as recurrence of cancer or regaining control of bladder function (continence) after surgery. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is uncertainty about some methods of surgery. All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to what is the best approach. This trial will evaluate whether the following two aspects of surgical technique influence outcome: Lymph node template. Prostate cancer can sometimes spread to the lymph nodes near the prostate. Surgeons often remove these lymph nodes to make sure that no cancer is left in the body. However, there is uncertainty about which lymph nodes to remove (the "template"). In particular, not all surgeons think that it is important to remove a large number of lymph nodes. Some believe that prostate cancer found in the lymph nodes is not aggressive. As a result, these surgeons feel that removing additional lymph nodes does not improve the chance that a patient will be cured. In the study patients will either have the standard lymph node dissection or a modified approach. Port site incision. Some surgeries are conducted with the help of what is called a surgical "robot", or using a laparoscopic approach (sometimes known as "keyhole" surgery). The surgeons have to make small cuts ("incisions") in order to insert their surgical instruments. Some surgeons believe that the way in which this cut is made can affect the chance that a patient will develop a hernia in the months after surgery. This is when tissues in the abdomen protrude through the incision, creating a small bulge that has to be surgically corrected. In the study, patients will either have the incision made vertically or horizontally. Antibiotics. About a week after surgery, you will return to the hospital to have your catheter removed. To guard against the chance of infection, you will be given antibiotics. These do help prevent infection, but are also harmful. Doctors are unsure whether to give a short course of antibiotics or whether patients really need several days of treatment. In the study, patients will receive antibiotics for either one or three days.

Start: July 2011

Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.

Start: September 2011

A Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to look for markers of how Ra-223 improves the lives of men with prostate cancer. This study makes use of Ra-223 in the standard FDA-approved way, but adds non-standard testing in an attempt to gain insight about how the drug works and how best to track patients who are receiving the drug.

Start: April 2015

Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Brazil, Canada, Ireland, Sweden, Switzerland, the United Kingdom (UK), and the US. Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of three years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment, every three months for the first and second year then every six months. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

Start: July 2017

Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer

Background: - Enzalutamide is a hormone therapy that is used to treat advanced prostate cancer. It is given after chemotherapy and surgery to help the body destroy the cancer cells. A new possible way of treating prostate cancer is using a vaccine that may help stimulate the immune system. It will help white blood cells recognize and kill the cancer cells in and around the prostate. Researchers want to see whether this vaccine, given with enzalutamide, is more effective at treating advanced prostate cancer than enzalutamide alone. Objectives: - To compare the safety and effectiveness of enzalutamide with and without vaccine therapy for advanced prostate cancer. Eligibility: - Men at least 18 years of age who have advanced castration-resistant prostate cancer. Design: Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be used to monitor the cancer before treatment. Participants will be separated into two groups. One group will have enzalutamide and the study vaccine. The other group will have enzalutamide alone. All participants will take enzalutamide once a day. They will take the drug during 4-week cycles of treatment. Treatment will be monitored with frequent blood tests and imaging studies. Participants will continue to take the study drug for as long as the cancer does not grow and the side effects are not severe. The vaccine group of participants will also have the new study vaccine. They will have a single injection on the first day of the first study cycle. There will be regular booster injections afterward. There will be one on day 15 of the first cycle, the first day of the second cycle. The vaccine will then be given every 4 weeks for the next four cycles, and then every 12 weeks (every 3 cycles) thereafter. Participants will continue to have the study vaccine for as long as the cancer does not grow and the side effects are not severe.

Start: August 2013

Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

Background: EP0057 consists of a sugar molecule cyclodextrin linked to a chemotherapy drug called camptothecin. The combined molecule or "nanoparticle drug conjugate" travels through the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule. Olaparib is a drug that may stop cancer cells from repairing the DNA damage caused by chemotherapy. Researchers want to see how safe it is to give EP0057 and olaparib together and to see how well the combination treats a specific type of lung cancer called small cell lung cancer (SCLC). Objectives: To test the safety and maximum dose of EP0057 and olaparib together. To test how well they treat small cell lung cancer. Eligibility: Adults 18 and older with small cell lung cancer. Design: Participants will be screened with standard cancer care tests. Participants will get the 2 study drugs in 28-day cycles. EP0057 will be given every 2 weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a day most days. Participants will keep a pill diary. For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits. At study visits, participants may have: Blood and hair samples taken History and Physical exam Questions about health and side effects Pregnancy test Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin. CT scan Injection of EP0057 (twice per cycle) Olaparib prescription <TAB> Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will have a physical exam and blood tests. They may have a tumor biopsy. The study team will call the patient every 3 months for follow up after completing the study treatment.

Start: May 2016

A Novel Augmented Reality System (ARssist) for the Assistant Surgeon in Robotic Assisted Surgery

Robotic prostatectomy is a surgery for treating localized prostate cancer. The ARssist system is a novel augmented reality system designed for the assistant surgeon, allowing delivery of augmented reality information via Microsoft HoloLens 2 (a head mount display developed by Microsoft) to better delineate the 3-D operative environment and enable better visualization. To date, there is no prospective study on the clinical performance and utilization of the ARssist system. This study is to evaluate the clinical feasibility and safety of the ARssist system during robotic surgery with the da Vinci Xi system.

Start: September 2021

Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI >25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.

Start: September 2018

Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection

Robotic prostatectomy (RARP) is a surgery for treatment localized prostate cancer. Bilateral pelvic lymph node dissection (BPLND) will also be performed if there is an estimated risk of occult nodal metastases exceeding 5%. BPLND in general is a well-tolerated procedure. Lymphatic leak is one of the possible complications after lymph node dissection (BPLND). Lymphocele is a collection of lymphatic fluid after operation. Hemopatch is a material used during operation that may prevent lymphorrhoea. This is a randomizedcontrolled trial that aims at investigating the application of Hemopatch to raw lymphatic tissue in preventing lymphorrhoea. Patients would be divided into 2 groups: with or without the use of Hemopatch during operation. They will be followed up on day 30 to monitor the course of recovery and any complications.

Start: February 2020

WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy

This is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo RP. Patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for RP.

Start: April 2019

Streaming Web-based Exercise At Home: A Pilot Study

This is a single-arm pilot study to evaluate the use of web-based video conferencing as a method of exercise training delivery. This study will include 10 female breast cancer survivors and 10 male prostate cancer survivors. For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.

Start: July 2020

Continuous Monitoring of Prostate Position During Radiotherapy

This study is investigating measurement of prostate motion during radiotherapy using the implanted gold markers. If motion is greater than 3mm then the beam will be stopped and position corrected (gating).

Start: January 2013

Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.

Start: January 2016

Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

The purpose of this research study is to learn about: 1) How standard radiation treatment to prostate (primary radiotherapy) or the pelvis after prostatectomy (postoperative radiotherapy) may cause changes in MRI and PET imaging traits that might be used in the future to predict response. 2) Comparison of such MRI and PET imaging traits with the number of circulating tumor cells (CTCs) present in the blood prior to treatment and the changes in these counts after treatment. 3) How MRI and PET imaging characteristics and changes are related to the expression of genes in the cancer tissue obtained before treatment from prostate biopsy or a prior prostatectomy before treatment. 4) How the response of prostate cancer treatment relates to the imaging and CTC changes.

Start: June 2016