View clinical trials related to Prostate Cancer.
Filter by:This is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer. Participants will receive regular standard of clinical care. The only study-specific procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission tomography/computed tomography) scan. Participants will be followed for two hours after the infusion for identification of any immediate adverse events (AE), and will be contacted by telephone after 7 to 14 days to enquire about any delayed AEs. PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. The standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the PET/CT scan.
The study drug, radium-223, gives off radiation that helps to kill cancer cells in the prostate. It is already available for patients to receive as a treatment for prostate cancer that has not responded to testosterone lowering treatment and has spread to the bones. This type of cancer is called metastatic castration-resistant prostate cancer, also called mCRPC. Sometimes, researchers continue studying an available treatment to learn more about how it affects patients' daily lives. In this study, the researchers want to learn more about how radium-223 affects the patients' ability to do their daily tasks. The patients in this study will already be receiving treatment with radium-223 as part of their routine care. The tests and measurements in this study will be done by the patients' own doctors. The researchers will collect information about the patients' treatment and results. The study will include patients with mCRPC who have at least 2 tumors in their bones. These patients will have recently started treatment with radium-223. The patients will have also had surgery or treatment to lower their testosterone levels. But, the treatment did not help their cancer. The study will include about 105 men in Colombia who are at least 18 years old. All of the patients will receive radium-223 through a needle put into the vein, also called an intravenous injection. They will visit their doctor's office up to 8 times during 28 weeks. At these visits, their doctors will ask how they are feeling and what medications they are taking, and will take blood samples. The doctors will also give the patients surveys about their physical, social, and emotional health and about the symptoms of their prostate cancer.
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Once the MTD is defined, the dose expansion phase is used to define the recommended phase 2 dose.
This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.
177Lu PSMA 617 is a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body. The purpose of this study is to find out whether 177Lu PSMA 617can slow the growth of prostate cancer compared to standard chemotherapy treatment
Several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in France. The oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. It is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. It shows why resistant mechanisms to treatment need to be elucidated. MicroRNA (miR) are short RNA, implicated in messenger ribonucleic acid (mRNA) regulation. Evidence is emerging that miR is implicated in prostate cancer response to treatment. It would be interesting to determine if a miR profile can predict treatment response to chemotherapy and/or to novel hormonal agents.
This is a phase 1 study to assess the safety and tolerability of ARX517 in adult subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
The miR Scientific Sentinel™ Prostate Cancer Classifier Platform (Sentinel™ PCC4 Assay) is a new molecular assay that interrogates 442 small non-coding RNAs extracted from urinary exosomes and provides urologists an early, very precise indication of disease status in men presenting with suspicion of prostate cancer. The assay classifies the disease status as having no molecular evidence of prostate cancer (NMEPC) or molecular evidence of low-, intermediate- or high-risk of aggressive, potentially lethal prostate cancer. The primary objective of this study is to assess the clarity of explanation of the biological background and clinical impact of the Sentinel™ PCC4 Assay, and the comfort level of urologists with the clinical data and report form, including the ease of understanding of results, and the potential use in clinical management of prostate cancer. Men being seen by urologists in the course of their normal practice, presenting with suspicion of prostate cancer (based on DRE and/or elevated Prostate Specific Antigen (PSA)) and scheduled for core-needle biopsy will be asked to consent to the clinical study and provide one or more 50 mL sample of non-DRE urine along with relevant anonymized clinical data with the study team. The urine samples will be shipped to miR Scientific laboratories in Rensselaer NY, for exosomal sncRNA extraction and interrogation. The molecular status of the participant will be reported as a Sentinel™ PCC4 Risk Level. The second primary objective of this study is to establish the performance characteristics of the Sentinel™ PCC4 Assay in the Puerto Rican population for identifying men with NMEPC, and men with evidence of high-risk prostate cancer. Participants will receive the standard of care (SOC), including measurement of PSA, DRE and TRUS-guided systematic or MRI-guided targeted biopsy. Based on the histopathology report of the core-needle biopsy, read by pathologists associated with local institution, participants with no positive cores will be designated "cancer-free"; otherwise patients with cancer in one or more cores will have the clinical data associated with the SOC collected (including the Gleason grade group, tumor staging, PSA, race and CAPRA risk assessment score). The CAPRA score will be compared to the molecular classification provided by the Sentinel™ PCC4 Assay.
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
Prostate cancer is the most common cancer in men in the United States. Suppression of male hormone levels by using GnRH agonist ("hormone blocking therapy") for a few years is routinely used to treat prostate cancer. While the treatment is very effective, it decreases muscle mass and increases fat mass. This results in a decrease in insulin action (also called insulin resistance) and increases the likelihood of diabetes. It may also contribute to risk of developing heart disease. The investigators propose to conduct a trial that will:- 1. study the mechanisms through which GnRH agonists cause insulin resistance. 2. Evaluate a treatment that can decrease insulin resistance. This is a randomized, placebo controlled, double-blind trial. Forty-four men with prostate cancer will be recruited in the trial before starting GnRH agonist therapy. Participants will undergo metabolic studies to evaluate insulin action (called insulin clamp), abdominal fat tissue biopsy to study insulin action at the cellular level and blood draws. The study volunteers will then be given either a placebo tablet or pioglitazone tablet to take once a day for the next six months. The metabolic tests, blood test and fat tissue biopsy will be obtained again at the end of the study.