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Home > "P" Clinical Trials Conditions > Protein Measures of Outcome of Radiation Therapy for Prostate Cancer  Protein Measures of Outcome of Radiation Therapy for Prostate Cancer
Protein Measures of Outcome of Radiation Therapy for Prostate Cancer
For Condition: Prostatic Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine whether proteins in the blood or urine can indicate the response to radiation therapy for localized prostate cancer. The results may help researchers determine the potential gain from improvements in radiotherapy and identify which patients may or may not benefit from aggressive treatment. Patients with localized prostate cancer who will have or have had radiation therapy to treat their disease may be eligible for this study. Participants will give a medical history and undergo a physical examination, including a digital rectal examination, determination of prostate-specific antigen (PSA) level, and in some cases, a bone scan. They will provide a urine sample and a blood sample. The samples will be used to identify what proteins are present in the blood and urine of men with prostate cancer and whether these proteins differ in men 1) who have not yet been treated for their disease, 2) who are free of disease after radiation therapy, and 3) whose prostate cancer has recurred
Details: There is a need for an early measure of outcome after definitive radiotherapy for localized prostate cancer. Such a surrogate marker would permit us to better measure the potential gain from improvements in radiotherapy, and to identify patients who may benefit from aggressive salvage therapy. It may also identify patients who are destined to fail local therapeutic strategies. Current surrogate measures, such as PSA level, digital rectal examination, and prostate biopsies, have limited sensitivity and specificity in detecting persistent or recurrent disease at an early stage. A new technology of protein profiling offers an important and powerful direction for the identification of new surrogate biomarkers. Samples consisting of blood and urine will be collected from cohorts of patients with localized prostate cancer either before or following definitive radiotherapy. These samples will be examined by SELDI using a panel of chemical chromatographic surfaces (protein capture chips). The protein patterns obtained by SELDI will be analyzed in order to identify shared protein patterns in a cohort of patients with a common clinical outcome, and to identify changes reproducible between patients that herald biochemical or clinical failure.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA Patients with a history of localized prostate cancer prior to, or having completed, definitive radiotherapy. EXCLUSION CRITERIA Inability to provide informed consent. Patient who have unobtainable data regarding previous therapy and/or clinical outcome.
Total Enrollment: 150
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020226; 02-C-0226
Study Start Date: June 7, 2002
Record last reviewed: April 15, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039806
Other Prostatic Neoplasms Studies:
1. A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma.
2. A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 Given Orally Once Daily in Subjects with Metastatic Prostate Cancer
3. A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
4. YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
5. Ketoconazole Plus Docetaxel to Treat Prostate Cancer
Related Studies:
Other Prostatic Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Protein Measures of Outcome of Radiation Therapy for Prostate Cancer
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