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Prostatic Neoplasms clinical trials

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NCT ID: NCT00096551 Completed - Prostatic Neoplasms Clinical Trials

A Phase I Feasibility Study of an Intraprostatic PSA-Based Vaccine in Men With Prostate Cancer With Local Failure Following Radiotherapy or Cryotherapy or Clinical Progression on Androgen Deprivation Therapy in the Absence of Local Definitive Therapy

Start date: November 1, 2004
Phase: Phase 1
Study type: Interventional

Background: - Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in patients with advanced prostate cancer. - Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in inducing antitumor effects than the s.c. route of administration, especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given s.c. This may be due to: - Making the tumor cell an antigen presenting cell via upregulation of both antigen (signal 1) and costimulatory molecules (signal 2). - Making the tumor cell more susceptible to killing via upregulation of ICAM. - The increased expression of perforin in peptide-specific T cells that came into contact with the TRICOM-infected targets. - Potentially allowing the immune system to select for other tumor encoded antigens to generate a polyvalent immune response. Objectives: - 1: Safety and feasibility of an intraprostatic vaccine strategy. - 2: To assess the change in PSA-specific T-cell response as measured by ELISPOT assay. - 2: To evaluate T-cell infiltration histologically in patients who have pre- and post-vaccine prostate biopsies. Eligibility: - Must have either a) biopsy proven, locally recurrent prostate cancer following local radiation as defined by the ASTRO consensus criteria as 3 consecutively rising PSA levels or b) have refused or not be candidates for local definitive therapy (surgery or radiation therapy) and have clinically progressive disease on androgen deprivation therapy (eg. three increases in PSA over nadir, separated by at least one week). For patients with previous RT, the biopsy confirming local recurrence must be done at least 18 months after the completion of RT. - Since this may also generate a systemic immune response, patients with minimal extraprostatic disease may be enrolled. - Hepatic function: Bilirubin < 1.5 mg/dl, AST and ALT< 2.5 times upper limit of normal Design: - Dose escalation Phase I design. Each cohort will consist of 3-6 patients, with cohorts 4 & 5 restricted to include only HLA-A2 + patients; maximum accrual is 30 - Patients in all cohorts receive initial priming with rV- PSA(L155)/TRICOM and rF-GM-CSF s.c. - The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSA(L155)/TRICOM. - Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSA(L155)/TRICOM - Last (5th) cohort u...

NCT ID: NCT00096499 Completed - Clinical trials for Adenocarcinoma of the Prostate

SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel

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

Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well SB-715992 works in treating patients with metastatic prostate cancer that did not respond to docetaxel or paclitaxel

NCT ID: NCT00095667 Completed - Clinical trials for Recurrent Prostate Cancer

Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer

Start date: November 2004
Phase: Phase 2
Study type: Interventional

Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.

NCT ID: NCT00093561 Completed - Prostate Cancer Clinical Trials

Lycopene in Preventing Prostate Cancer in Healthy Participants

Start date: August 2004
Phase: Phase 1
Study type: Interventional

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer. PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.

NCT ID: NCT00093457 Completed - Prostate Cancer Clinical Trials

Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

Start date: August 10, 2004
Phase: Phase 2
Study type: Interventional

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.

NCT ID: NCT00091390 Completed - Prostate Cancer Clinical Trials

Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer

Start date: July 2004
Phase: Phase 2
Study type: Interventional

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.

NCT ID: NCT00090545 Completed - Prostate Cancer Clinical Trials

A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer

Start date: September 1, 2004
Phase: Phase 2
Study type: Interventional

BAY 43-9006 (Sorafenib) is an experimental cancer drug produced by Bayer Health Care Corporation. It represents a new class of anticancer agents known as bi-aryl ureas. This study will investigate its effect on prostate cancer and its side effects. Researchers expect to enroll a maximum of 46 men with prostate cancer for this study. The duration of the study will depend on its results. Before beginning to take the drug, patients will be admitted to the hospital for 2 days, have a medical examination and give blood samples, and have a tumor or bone marrow biopsy. On the first day of the study, patients will begin taking the drug as 2 tablets twice daily, morning and evening. Blood will be taken throughout the day to determine the drug's level in the bloodstream. Patients will be discharged from the hospital on the second day, and will continue to take the drug twice daily until instructed to stop. During each of the first 4 weeks, patients will be required to have their blood pressure checked. At the end of the first 4 weeks, patients will have a physical examination and blood tests, as well as a second tumor or bone marrow biopsy. After the first 4 weeks, patients will continue with their drug regimen. At the end of each 4-week cycle, patients will have a physical examination and blood tests. Patients will also have x-Rays, computed tomography (CT) scans, and/or magnetic resonance imaging (MRIs) at every other 4-week examination or as required. Patients will be asked to keep a diary recording the time and amount of their medication for this study.

NCT ID: NCT00090376 Completed - Prostate Cancer Clinical Trials

Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy

Start date: December 2003
Phase: Phase 2
Study type: Interventional

In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is being assessed to see if it can help preserve erectile function after prostatectomy.

NCT ID: NCT00090363 Completed - Prostate Cancer Clinical Trials

ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

Start date: July 2004
Phase: Phase 2
Study type: Interventional

This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

NCT ID: NCT00089674 Completed - Prostate Cancer Clinical Trials

AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

Start date: August 1, 2004
Phase: Phase 3
Study type: Interventional

This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.