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Prostatic Neoplasms clinical trials

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NCT ID: NCT00976755 Completed - Prostate Cancer Clinical Trials

Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer

Start date: September 14, 2009
Phase: Phase 2
Study type: Interventional

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects of everolimus and to see how well it works as first-line therapy in treating patients with prostate cancer.

NCT ID: NCT00975429 Completed - Prostate Cancer Clinical Trials

Study Using WST11 in Patients With Localized Prostate Cancer

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The aim of this trial is to determine the optimal treatment conditions to achieve prostate cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted Photodynamic therapy (VTP) treatment in patients with localized prostate cancer. The secondary objectives are to assess the safety and quality of life following WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the duration of the VTP procedure.

NCT ID: NCT00974311 Completed - Clinical trials for Castration-Resistant Prostate Cancer

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy

AFFIRM
Start date: September 30, 2009
Phase: Phase 3
Study type: Interventional

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

NCT ID: NCT00973882 Completed - Prostate Cancer Clinical Trials

Carboplatin-Etoposide Combination in Hormone-Resistant Prostate Cancers

Start date: April 2005
Phase: Phase 2
Study type: Interventional

The aim of our study is to assess the efficacy and toxicity of a chemotherapy regimen combining carboplatin and etoposide in patients with metastatic hormone-resistant prostate cancer and neuro-endocrine differentiation. Eligible patients are treated with the combination of carboplatin AUC4 on day 1 and etoposide 100 mg/m2 on day 1, day 2 and day 3 repeated every 3 weeks for a maximum of 6 cycles. Efficacy endpoints include Prostate Specific Antigen (PSA) and neuro-endocrine marker response (defined as a 50% or greater decrease from baseline serum values), objective response rate (according to RECIST criteria), and toxicity.

NCT ID: NCT00972309 Completed - Prostate Neoplasms Clinical Trials

A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer

Start date: May 11, 2009
Phase: Phase 1
Study type: Interventional

Background: - PSA (prostate specific antigen) is a protein found on normal and cancerous prostate cells. Levels of this protein are used to identify men who are at risk for prostate cancer and to monitor responses to treatment in men who have been diagnosed with prostate cancer. - Research has shown that men who continue to have an elevated PSA level following primary treatment for prostate cancer are at increased risk for cancer progression. Studies have shown that the change in PSA levels over time, or PSA doubling time (PSADT), can be accurate in predicting how quickly the cancer is likely to progress. Individuals with a PSADT of less than 3 months are at extremely high risk for disease progression and death from prostate cancer. Individuals with a PSADT of greater than 15 months have a very low risk of death from prostate cancer. - T-cell receptor alternate reading frame protein (TARP) is a protein that is found in about 95% of prostate cancers and is known to stimulate the immune system. The TARP prostate cancer vaccine is made from pieces of the TARP protein called peptides and includes peptides that have been modified to make them more effective at stimulating immunity. Although these TARP peptides have been shown to stimulate the immune systems of mice, information is needed to determine if they also stimulate the immune system in humans. Since it is unclear what is the best way to give peptide vaccines, the TARP peptides will be given with substances known to stimulate the immune system or in a vaccine made with the patient s own cells. Objectives: - To determine the immune systems response to vaccination with TARP peptides. - To determine the safety and toxicity of TARP peptide vaccination. - To determine if vaccination with the TARP prostate cancer vaccine can slow down PSADT in men with an intermediate PSADT of 3 to 15 months. Eligibility: - Males 18 years of age and older who have completed their primary treatment for prostate cancer, have stage D0 disease, are Human leukocyte antigen (HLA) A*0201 positive and who have a PSADT greater than 3 and less than 15 months. Design: - Patients will be randomized to one of two treatment arms: - Arm A will receive the TARP vaccine with other substances that stimulate the immune system. - Arm B will receive the TARP vaccine that includes a patients own white blood cells. - First week of study, after screening for eligibility has been completed: - Day 1: Apheresis procedure to extract white blood cells to test the immune response to the vaccine. - Day 3: Flu vaccine to allow researchers to determine how well a patients immune system is working. - Clinic visits in Weeks 3, 6, 9, 12, and 15 for physical examination, blood samples, and administration of the TARP peptide vaccine. - Physical examination and blood samples only in Weeks 18 and 36. - Additional blood samples and apheresis procedures in Weeks 24 and 48. - A 6th dose of TARP peptide vaccine will be administer to those patients who have a response to vaccination at week 24. - No follow-up or long-term study is associated with this study.

NCT ID: NCT00970203 Completed - Prostate Cancer Clinical Trials

Dendritic Cell (DC)-Based Vaccines Loaded With Allogeneic Prostate Cell Lines in Combination With Androgen Ablation in Patients With Prostate Cancer

Start date: September 2009
Phase: Phase 2
Study type: Interventional

This study will evaluate the feasibility, safety, and efficacy of intradermal vaccination of prostate cancer patients with alpha-type-1-polarized dendritic cells (DC1) loaded with apoptotic allogeneic tumor (LNCap). The study will target men with recurrent prostate cancer, who failed local therapy, have no measurable metastasis, but have a rising PSA with a doubling time of less than 10 months. The selection of this study group enables us to evaluate time to PSA progression, a highly relevant, clinical primary endpoint of efficacy in this two arm study. In order to facilitate infiltration of vaccination-induced T cells into tumor site(s) and to reduce tumor-specific tolerance, subjects will receive the vaccine in combination with limited androgen ablation (AA) with a LHRH analogue for 3 months. Subjects will be randomly assigned to one of two cohorts. In cohort A subjects will be first treated with limited AA alone for 3 months, and at the time of PSA relapse (PSA ≥ 1 ng/dL) will receive the DC vaccine in conjunction with AA. In cohort B, the sequence of treatment will be reversed. Efficacy will be estimated as the within-subject difference in time to PSA relapse following the combination treatment as compared to the AA alone, thus, each subject will serve as his own control. All subjects will commence the DC1-based vaccination 2 weeks prior to treatment with the LHRH analogue. Each subject will receive 1 intradermal (i.d.) dose of the vaccine at weeks 1, 5, 9, and 13 for a total of 4 doses. Additional courses of vaccination may be administered to subjects without evidence of disease progression every 3 months (±1 month) for up to 12 months depending on the number of doses originally produced and available after the 4 intended protocol doses. All doses of the vaccine will be administered intradermally (i.d.).

NCT ID: NCT00967018 Completed - Prostate Cancer Clinical Trials

A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

Start date: August 2009
Phase: Phase 3
Study type: Interventional

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

NCT ID: NCT00964002 Completed - Prostate Cancer Clinical Trials

Efavirenz in Treating Patients With Metastatic Prostate Cancer

FAVE
Start date: May 2008
Phase: Phase 2
Study type: Interventional

RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.

NCT ID: NCT00963911 Completed - Breast Cancer Clinical Trials

Validation of a Screening Tool in Geriatric Oncology

ONCODAGE
Start date: August 5, 2008
Phase: N/A
Study type: Interventional

RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer. PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.

NCT ID: NCT00963755 Completed - Prostate Cancer Clinical Trials

F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer

Start date: August 2009
Phase:
Study type: Observational

The purpose of this study is to demonstrate that realization of guided biopsies by multimodal imaging with 18F-fluorocholine PET / CT and MR Imaging/spectroscopy would allow to increase the rate of detection prostate cancer compared with the current approach and give an information about location and tumoral volume before surgery.: