What if I am harmed? Are there any tests requiring painful shots or blood samples? Will I be paid? Will I be reimbursed for gas? What kinds of medical problems would prevent participation in the clinical trial? Do I have to talk to my health insurance company before enrolling in a study?
What if I miss a dose? Can I drop out at any time? Are there placebos involved? If you decide that a clinical study may be right for you, make a list of questions and discuss them with the study doctor at your initial visit.
What happens after a study is complete? If it remains in development, the sponsor may build in a compassionate use extension for the study. This means that eligible patients may receive the study drug for a predefined amount of time without having to undergo any typical study procedures, such as blood tests or clinical ratings.
In some cases, a study doctor may dispense approved medication samples and provide additional consultation free of charge. These are just a few of the ways he or she might show appreciation for a patients involvement in a study.
What are the phases of the clinical trial process? There are three primary phases an investigational drug has to go through before it can be approved by the FDA, and a fourth phase that an approved drug may enter. Phase I In this phase of a clinical trial, the sponsor wants to determine the maximum tolerated dose for the medication. Mode of action how the drug exerts its effects , safety and side effects — these are some of the main issues that are of the utmost concern to drug makers at this stage of the clinical trial process.
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Grants Management Contacts. Prior Approvals. The purpose of this study is to evaluate androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. This research trial studies gene expression in patients with metastatic prostate cancer receiving cytochrome P CYP inhibition therapy.
Studying samples of tissue, blood, and urine in the laboratory from patients receiving CYP inhibition therapy may help doctors learn more about changes that occur in deoxyribonucleic acid DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.
The purpose of this study is to assess the effectiveness of treatment with docetaxel and prednisone, with or without vaccine therapy for patients who have hormone-resistant prostate cancer that has spread to other parts of the body.
Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from an antigen may help the body build an effective immune response to kill tumor cells. It is not yet known whether docetaxel and prednisone are more effective with This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A CgA after a definitive radiotherapy RT with or without androgen deprivation therapy ADT is associated with a higher risk of prostate cancer recurrence after RT.
CgA is also measured at various pre-defined post-RT time points. The study will analyze the followings: 1. Change in CgA level at various pre-defined post-RT time points from the baseline, 2.
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib. The purpose of this study is to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
The purpose of this study is to assess how well multiparametric magnetic resonance imaging MRI works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.
The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair defects in a population of men with metastatic Prostate Cancer PC , and to use the variants reported to assess biomarker eligibility for niraparib interventional studies. The purpose of this study is to investigate MR-guided cryoablation of biopsy proven Gleason 7 prostate cancers using the Galil MR-compatible cryoablation system to monitor the technqiue and prospectively collect the data.
The system is already FDA k approved for soft tissue ablation and has been utilized successfully at Mayo previously. This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body. 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.
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.
The endpoints selected reflect measurable short term effects of androgen deprivation therapy ADT , including quality of life and several metabolic parameters. In addition, the relative effect of each treatment strategy on PSA suppression as well as testosterone recovery and subsequent PSA progression after 12 months of therapy will be evaluated.
The purpose of this study is to establish the recommended phase 2 dose RP2D of niraparib combination therapies of Part 1 and to evaluate the antitumor activity and safety of niraparib combination therapies of Part 2.
This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer mCRPC. Stereotactic ablative body radiotherapy SABR , or stereotactic body radiotherapy SBRT , is a specialized form of radiotherapy used to treat prostate cancer with five treatments over two weeks, compared with a conventional eight-week or longer treatment course.
The purpose of this trial is to investigate the effect that proton-based SABR has on quality-of-life in patients with localized prostate cancer. The evaluation and treatment will otherwise follow standard of care, and is not considered investigational. Patients undergo evaluation and medical care in the same way that they would if they were not part of this trial.
This may include standard of The purpose of this study is to confirm that adding custirsen to standard first-line docetaxel and prednisone treatment can slow tumor progression in men who have prostate cancer, and enhance survival outcomes compared to standard first-line docetaxel and prednisone treatment alone.
This randomized phase II trial studies how well a controlled low calorie diet works in reducing side effects and increasing response to chemotherapy in patients with breast or prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Eating a special diet with low calories may reduce the side effects of chemotherapy and improve the response to treatment.
The objective of this study is to compare perioperative and oncologic outcomes of patients undergoing open and robotic prostatectomy for prostate cancer. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
The purpose of this study is to clinically test the use of a questionnaire to determine how well it detects differences in knowledge about prostate cancer among newly diagnosed individuals with the disease. The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.
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