Cone Beam CT for Daily Image Guidance - Prostate Cancer
Prostatic NeoplasmsConformal dose escalated radiation therapy (CRT) is standard treatment for patients with low and intermediate risk prostate cancer. CRT requires accurate daily localization of the prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone Beam CT also provides important information on daily position of organs within the pelvis. This study aims to assess the feasibility of cone beam CT for daily localization of the prostate as well as document changes in size and location of pelvic organs during an entire course of CRT.
A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory...
Hormone Refractory Prostate CancerBone MetastasesThis study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.
Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer
Prostate CancerThis study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.
A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance
Prostate CancerThis study is a clinical trial to determine whether a 12-week group therapy intervention for patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal of the study is to further our understanding of anxiety in men who have been diagnosed with prostate cancer and are undergoing Active Surveillance. Men who have elected Active Surveillance for their management of prostate cancer are eligible to participate in this study. After signing informed consent, all participants will complete two brief questionnaires (The Memorial Anxiety Scale for Prostate Cancer [MAX-PC] and the General Anxiety and Depression Scale 7 [GAD-7] to measure their anxiety levels. If the participant scores above a certain number, they will be asked to participate in the study. Patients will be randomly assigned to either a control group, who will receive no treatment, but continue to follow up with their urologist to manage their prostate cancer as usual, or the treatment group. The treatment group will receive 12 one-hour group therapy sessions that will take place once a week for 12 weeks with a licensed psychologist free of charge. They will be instructed to follow up with their urologist as previously determined for their prostate cancer management. Patients in both groups will be monitored for anxiety completing three questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If patients require further therapy beyond the group treatment sessions, the investigators may refer them to a psychologist or psychiatrist for further treatment.
Hypertension Management in Cancer Patients
Blood PressureHypertension6 moreThe investigators propose to leverage new technology using the Qardio app for iPhone and Android devices to automatically upload blood pressures, using a well-validated blue tooth blood pressure monitor (QardioArm), directly into the Duke electronic health record system (EPIC). Further, the investigators propose to develop an automated EHR (electronic health record) messaging system utilizing the home blood pressures that will be sent to the participant's PCP, with copies to the participant and the primary oncologist. This is a 12-week prospective non-randomized implementation study. 40 patients who are 18-74 years old who fall under the following criteria will be screened: 10 women with Stage 1-III breast cancer who are receiving either an anthracycleine of antiHER2 therapy, 10 men with prostate cancer on ADT, 10 individuals with CLL on ibrutinib therapy, and 10 individuals who are hematopoietic stem cell transplantation (HSCT) survivors. In Phase 1 (Weeks 1-4) of the study, participants will self-monitor their blood pressure using the QardioArm wireless upper arm blood pressure monitor 3 times per week. In Phase 2 (Weeks 5-12), the investigators will implement the auto-messaging system triggered by an abnormal weekly average systolic or diastolic blood pressure. The investigators will adapt the conceptual framework of Muldoon and colleagues whereby home blood pressure monitoring is combined with office blood pressures to optimize data for the primary care provider's clinical decision making. {Participants will be asked to complete a paper survey, upon enrollment, that will include life chaos and medication adherence questions. There will also be an end-of-study feedback survey (usability and acceptability questions through REDCap) for both the participants and their primary care providers. This is an implementation study with a descriptive analysis. The data generated from the study will be used in future studies, including testing of different interventions aimed at optimizing blood pressure control among patients on active cancer therapy. This study presents no greater than minimal risk to the subjects and adverse events are not anticipated.
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients...
Low Anterior Resection SyndromeMalignant Anal Neoplasm9 moreThis phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.
Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration...
Prostate CancerBackground: Enzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver the effective dose. This can be difficult for people already taking multiple drugs. And swallowing may be difficult for some people. Researchers want to test out a new way of giving enzalutamide by mouth. They want to see if giving a person the liquid taken from inside the standard 4 gelatin capsules is handled by the body in the same way as giving them the capsules whole. Objectives: To compare how capsule and liquid forms of enzalutamide are handled by people with prostate cancer. Eligibility: Men at least 18 years old with prostate cancer Design: Participants will be screened with a heart test (electrocardiogram), medical history, and physical exam. A tissue sample or lab reports will be reviewed. During the study, participants will repeat screening tests and have urine tests. Participants will be randomly assigned to get the study drug in one of two orders: either the as capsules then the liquid form (Arm A) or as the liquid form then the capsule form (Arm B). Participants will be counseled about birth control. The study will have 2 periods with a minimum 42 day break in between. On Day 1 of Period 1 and Day 1 of Period 2, participants will be admitted to the hospital. They will get one dose of the study drug. They cannot eat or drink anything except water for at least 10 hours before and for 4 hours after the study drug. Their blood will be sampled over 24 hours. Lunch and dinner will be served. Participants will answer questions after taking the liquid form. Participants will have blood drawn on Day 3, Day 8, and Day 42.
Protection of Rectum From High Radiation Doses Using a Spacer
Prostatic NeoplasmsGenital Neoplasms3 moreThe purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.
Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
FatigueHot Flashes1 moreRATIONALE: Acupuncture may help relieve hot flashes in patients with prostate cancer. PURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes in patients with prostate cancer who are undergoing androgen deprivation.
Combination Study of AZD5069 and Enzalutamide.
Metastatic Castration Resistant Prostate CancerACE is a multi-centre proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer(mCRPC). The investigators will be investigating the safety and toxicity of the combination.