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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR calculated for the subgroup of participants with a confirmed objective tumor response. Pain severity recorded on a numerical scale ranging from 0 no pain to 10 pain as bad as you can imagine.
FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate. Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy resistant or intolerant. ECOG 0 or 1. Chemotherapy within 3 weeks.
Impending complications from bone metastases. Ongoing urinary obstruction. CNS involvement. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials.
Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. Epub Dec 9. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Recruitment Status : Terminated Study A was prematurely discontinued due to futility on 27 September Prostatic Neoplasms. Drug: Prednisone Drug: sunitinib Drug: Placebo. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Drug: Placebo Thousands Oaks, California, United States, Westlake Village, California, United States, Arlington Heights, Illinois, United States, Study record managers: refer to the Data Element Definitions if submitting registration or results information.
To establish feasibility and maximum tolerated dose MTD of steroid therapy that provides symptomatic improvement in oropharyngeal cancer OPC survivors with late lower cranial neuropathy LCNP. To examine endpoints that may be sensitive to functional or symptomatic gains with steroid therapy for late LCNP in OPC survivors by characterizing changes in symptoms, functional status, quality of life QOL , neurophysiology, and imaging studies after steroid therapy.
To establish a hypothesis-generating database of physiologic, functional, and patient-reported outcomes PROs among head and neck cancer HNC survivors with late lower cranial neuropathy treated with steroid therapy. Patients receive prednisone orally PO or by feeding tube once daily QD on days and then taper off over 2 weeks or methylprednisolone intravenously IV over 1 hour on days in the absence of disease progression or unacceptable toxicity.
Nerve conduction study NCS scores are based on a 4-point scale ranging from 'none' best to 'severely prolonged' or 'severely reduced' worst. LROM scores are rated on an ordinal scale from 0 worst to best. EQ-5D is rated on a continuous scale from 0 worst to best. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : May 13, See Contacts and Locations. Study Description. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy.
Detailed Description:. Drug Information available for: Prednisone Methylprednisolone. FDA Resources. Arms and Interventions.
❿Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate. Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy resistant or intolerant. ECOG 0 or 1. Chemotherapy within 3 weeks. Impending complications from bone metastases. Ongoing urinary obstruction. CNS involvement. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. Epub Dec 9. National Library of Medicine U. National Institutes of Health U.
Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Recruitment Status : Terminated Study A was prematurely discontinued due to futility on 27 September Prostatic Neoplasms.
Drug: Prednisone Drug: sunitinib Drug: Placebo. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Drug: Placebo Thousands Oaks, California, United States, Westlake Village, California, United States, Arlington Heights, Illinois, United States, Kernersville, North Carolina, United States, Goyang-si, Gyeonggi-do, Korea, Republic of, Seongnam, Gyunggido, Korea, Republic of, L'hospitalet de Llobregat, Barcelona, Spain, May 13, Key Record Dates.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study.
Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details. Last Update Posted : May 13, See Contacts and Locations. Study Description. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy. Detailed Description:.
Drug Information available for: Prednisone Methylprednisolone. FDA Resources. Arms and Interventions. Other Names:. Outcome Measures. Secondary Outcome Measures : Improvement in tongue innervation on electromyography EMG findings [ Time Frame: Up to 3 years ] EMG scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'.
MILS scores are rated on continuous scale from 0 worst to best. MDADI scores are rated on a continuous scale from 20 worst to best. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations.
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Scores ranged from 0 not at all to 4 very much. The 12 prostate cancer symptoms items focus on pain 3 items , urination problems 3 items , sexual functions 2 items , weight loss, appetite, overall comfort, and bowel movement. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state no problems ; 3 indicates worst health state "confined to bed".
Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. No new or unexpected safety issues were identified.
First Posted : May 13, Results First Posted : March 8, Last Update Posted : March 8, Study Description. This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study. MedlinePlus related topics: Prostate Cancer Steroids.
FDA Resources. Arms and Interventions. Outcome Measures. Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR calculated for the subgroup of participants with a confirmed objective tumor response. Pain severity recorded on a numerical scale ranging from 0 no pain to 10 pain as bad as you can imagine.
FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate. Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy resistant or intolerant. ECOG 0 or 1. Chemotherapy within 3 weeks. Impending complications from bone metastases. Ongoing urinary obstruction.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials.
Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Last Update Posted : May 13, See Contacts and Locations. Study Description. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy. Detailed Description:. Drug Information available for: Prednisone Methylprednisolone. FDA Resources. Arms and Interventions. Other Names:. Outcome Measures. Secondary Outcome Measures : Improvement in tongue innervation on electromyography EMG findings [ Time Frame: Up to 3 years ] EMG scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'.
MILS scores are rated on continuous scale from 0 worst to best. MDADI scores are rated on a continuous scale from 20 worst to best. Eligibility Criteria.
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. For participants who were alive, overall survival was censored at the last contact. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. Duration of Response DR [ Time Frame: Baseline, every 8 weeks up to weeks ] Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause.
Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.
DR calculated for the subgroup of participants with a confirmed objective tumor response Change From Baseline in Pain Severity [ Time Frame: Day 1 through Day 7 every 28 days every cycle up to 29 months ] Pain severity recorded on a numerical scale ranging from 0 no pain to 10 pain as bad as you can imagine. Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days. Scores ranged from 0 not at all to 4 very much.
The 12 prostate cancer symptoms items focus on pain 3 itemsurination problems 3 itemssexual functions 2 itemsweight loss, appetite, overall comfort, and bowel movement. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state no problems ; 3 indicates worst health state "confined to bed".
Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. No new or unexpected safety issues were identified. First Posted : May 13, Results First Posted : March 8, Last Update Posted : March 8, Study Description. This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen.
This is a second-line study. MedlinePlus related topics: Prostate Cancer Steroids. FDA Resources. Arms and Interventions. Outcome Measures. Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause.
DR calculated for the subgroup of participants with a confirmed objective tumor response. Pain severity recorded on a numerical scale ranging from 0 no pain to 10 pain as bad as you can imagine.
FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate. Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy resistant or intolerant.
ECOG 0 or 1. Chemotherapy within 3 weeks. Impending complications from bone metastases. Ongoing urinary obstruction. CNS involvement. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer.
J Clin Oncol. Epub Dec 9. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Recruitment Status : Terminated Study A was prematurely discontinued due to futility on 27 September Prostatic Neoplasms. Drug: Prednisone Drug: sunitinib Drug: Placebo. Phase 3. Study Type :. Interventional Clinical Trial.
Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Drug: Placebo Thousands Oaks, California, United States, Westlake Village, California, United States, Arlington Heights, Illinois, United States, Kernersville, North Carolina, United States, Goyang-si, Gyeonggi-do, Korea, Republic of, Seongnam, Gyunggido, Korea, Republic of, L'hospitalet de Llobregat, Barcelona, Spain, May 13, Key Record Dates.
Prednisone is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune. Deltasone Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and. Wyacort. Drug: Prednisone. Given PO. Other localhostortisone; 1, 2-Dehydrocortisone; Adasone. Treatment Arm A - sunitinib + prednisone. Drug: Prednisone. 5 mg BID, oral. Other Name: Deltasone. Drug: sunitinib. mg/day, oral, administered on a. The postulated mechanisms of action of corticosteroids in brain tumors include Prednisone (Deltasone, Rayos, Prednisone Intensol). Contacts and Locations. Actual Study Completion Date :. This is a second-line study. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Last Update Posted : May 13, Arms and Interventions. ECOG 0 or 1.Study record managers: refer to the Data Element Definitions if submitting registration or results information. To establish feasibility and maximum tolerated dose MTD of steroid therapy that provides symptomatic improvement in oropharyngeal cancer OPC survivors with late lower cranial neuropathy LCNP. To examine endpoints that may be sensitive to functional or symptomatic gains with steroid therapy for late LCNP in OPC survivors by characterizing changes in symptoms, functional status, quality of life QOL , neurophysiology, and imaging studies after steroid therapy.
To establish a hypothesis-generating database of physiologic, functional, and patient-reported outcomes PROs among head and neck cancer HNC survivors with late lower cranial neuropathy treated with steroid therapy. Patients receive prednisone orally PO or by feeding tube once daily QD on days and then taper off over 2 weeks or methylprednisolone intravenously IV over 1 hour on days in the absence of disease progression or unacceptable toxicity. Nerve conduction study NCS scores are based on a 4-point scale ranging from 'none' best to 'severely prolonged' or 'severely reduced' worst.
LROM scores are rated on an ordinal scale from 0 worst to best. EQ-5D is rated on a continuous scale from 0 worst to best. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think!
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : May 13, See Contacts and Locations.
Study Description. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy. Detailed Description:. Drug Information available for: Prednisone Methylprednisolone. FDA Resources. Arms and Interventions. Other Names:. Outcome Measures. Secondary Outcome Measures : Improvement in tongue innervation on electromyography EMG findings [ Time Frame: Up to 3 years ] EMG scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'.
MILS scores are rated on continuous scale from 0 worst to best. MDADI scores are rated on a continuous scale from 20 worst to best. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Layout table for location contacts Contact: Katherine A Hutcheson karnold mdanderson. Hutcheson karnold mdanderson. Anderson Cancer Center. More Information. National Library of Medicine U.
National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Phase 1 Phase 2. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Experimental: Supportive care steroid therapy Patients receive prednisone PO or by feeding tube QD on days and then taper off over 2 weeks or methylprednisolone IV over 1 hour on days in the absence of disease progression or unacceptable toxicity.
Contact: Katherine A. Principal Investigator: Katherine A. November 5, Key Record Dates.
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