7 Clinical Trials for Various Conditions
This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V).
The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).
Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression.
Background: - Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die. Radiation can be effective, but some tumors may be harder to treat with radiation or even with surgery. This happens to a small number of men who have either radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not know if the tumor has recurred only in the prostate or has spread to another area. Also, men whose prostate cancer has recurred only after radiation may have different treatment options. This study will use improved imaging studies to better understand why some men do not respond as well to initial radiation treatments. Objectives: - To use detailed imaging studies to look at the results of local radiation therapy for prostate cancer. Eligibility: * Men at least 18 years of age who are scheduled to have radiation for prostate cancer. * Men at least 18 years of age whose prostate cancer has returned after earlier treatments. Design: * All participants will have a medical history and physical exam. Blood and urine samples will be collected. Imaging studies will be used to evaluate the cancer at the start of the study. * All participants will have an initial full magnetic resonance imaging (MRI) scan of the prostate. Tumor and healthy tissue samples will be collected. * Those whose cancer has recurred after treatment will discuss possible treatment options with the study doctors. * Participants who are scheduled to have radiation will have radiation therapy. This will be given according to the current standard of treatment. * After radiation, participants will have regular follow-up tests and imaging studies. They will have another full MRI scan 6 months after the end of radiation treatment.
This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed of the prostate in patients who have developed biochemical failure of their prostate cancer. The main objective of this study is to determine the maximum tolerated dose and dose limiting toxicity for the combination of satraplatin and radiation therapy and to determine the recommended dose for subsequent Phase II trials.
This Phase 1 trial will evaluate the safety and tolerability of PSA-Activated PSA-PAH1 in subjects who have shown biochemical failure and have either completed at least one primary radiation therapy for prostate cancer and have evidence of recurrent local prostate cancer without metastases.
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...