View clinical trials related to Genital Diseases, Male.
Filter by:The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design, dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior to or concurrent with enrolling patients in Part II. In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in each cohort) will be enrolled.
The purpose of this study is to determine whether testosterone plus finasteride treatment will improve musculoskeletal health, neuromuscular function, body composition, and metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. The investigators hypothesize that this treatment will improve bone mineral density, enhance muscle size and muscle function, and improve body composition, without causing prostate enlargement.
The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery. Prostate cancer is a common and important health issue facing men in the United States. Most patients with prostate cancer are identified when the disease is limited to the prostate gland itself (localized prostate cancer). A standard treatment for some patients with localized prostate cancer is removal of the prostate gland in an operation known as a "radical prostatectomy." A sub-set of patients with localized prostate cancer can be identified who are at high-risk of suffering a recurrence of prostate cancer after radical prostatectomy. For these patients, additional treatments are being investigated to combine with surgery in the hopes of increasing the chances for cure. Several kinds of chemotherapy medicines have been used for advanced prostate cancer which returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the epothilone class of chemotherapy medicines that has shown encouraging results for the treatment of advanced prostate cancer and other cancers in clinical trials. This trial will include men with high-risk localized prostate cancer who will receive treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal of this trial will be to determine if analysis of genes and proteins in prostate cancer tissue taken before and after treatment can be used to predict ixabepilone response. In addition, this trial will evaluate the safety and feasibility of administering ixabepilone prior to radical prostatectomy for patients at high-risk of developing recurrent prostate cancer. The study has three phases: Screening, Treatment and Follow-up - Screening: Eligibility will be verified - Treatment: Subjects will receive Ixabepilone, which will be administered every 21 days for 4 cycles prior to surgery - Follow up: Subjects will be followed every 6 months for up to 5 years. In addition, tissue will be collected at the time of surgery for genetic and protein studies. Blood will also be collected pre and post therapy for proteomic and/or genetic studies.