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Prostate Cancer clinical trials

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NCT ID: NCT01739062 Active, not recruiting - Prostate Cancer Clinical Trials

The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

ProCaRis
Start date: February 2013
Phase: N/A
Study type: Interventional

The preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic screening. Genetic risk assessment may be a better way to identify men with low risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can reduce the number of patients who get a PSA test as part of unsystematic screening.

NCT ID: NCT01737242 Active, not recruiting - Prostate Cancer Clinical Trials

UK Genetic Prostate Cancer Study: Epidemiology and Molecular Genetics Studies

UKGPCS
Start date: January 1993
Phase:
Study type: Observational

The UKGPCS was set up to find genetic alterations which occur in patients who have prostate cancer. A man's risk of developing prostate cancer increases if he has a first-degree relative (father or brother) who was diagnosed with prostate cancer at a young age. This is why we are looking for men who are affected at a young age or who have a family history of prostate cancer, since it is more probable that these prostate cancers are due to an inherited genetic cause rather than an environmental cause. We also ask all men who come to the Royal Marsden Hospital to be treated for prostate cancer if they would like to take part in the study so that we can also look to see if we find genetic alterations in older men, and those who do not have a family history of prostate cancer.

NCT ID: NCT01735396 Terminated - Prostate Cancer Clinical Trials

Abiraterone Acetate Trial in African American Prostate Cancer Patients

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patients with castration-resistant prostate cancer treated with abiraterone acetate. Patients will receive abiraterone acetate until the time of disease progression, in the absence of prohibitive toxicities. Patients will be followed for disease progression and survival.

NCT ID: NCT01734681 Withdrawn - Prostate Cancer. Clinical Trials

Phase 2 Study of G-202 in Patients With Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer

Start date: May 2013
Phase: Phase 2
Study type: Interventional

Prostate cancer that has returned after local treatment usually responds to hormone blocking treatment, but most patients eventually experience disease progression. Further chemotherapy does not normally lead to a cure or dramatic improvement in the disease and there is a need to identify new drugs that are beneficial for these patients without unacceptable side effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is administered to the patient and gets activated within the body at specific locations, resulting in a higher concentration of the cytotoxic form at a tumour location whilst avoiding general side effects. G-202 is an example of prodrug chemotherapy. It does not have many general side effects because it is converted to a cell toxin only at the tumour or other specific locations in the body. G-202 is activated by Prostate Specific Memory Antigen (PSMA), a substance expressed by prostate cancer cells and in the blood vessels of most solid tumours, but not by normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug G-202 will allow the drug to kill cancer cells, particularly prostate cancer cells. This study will evaluate the activity and safety of G-202 in men with castration-resistant prostate cancer (CRPC), which means the cancer has progressed after hormone blocking treatment, but who have not yet received chemotherapy and who have no or only a few symptoms from their CRPC. The study will evaluate clinical activity and safety of G-202 administered on three consecutive days of a 28-day cycle.

NCT ID: NCT01733836 Withdrawn - Prostate Cancer Clinical Trials

Prostate Cancer Active Surveillance Metformin Trial

Start date: January 2013
Phase: Phase 2
Study type: Interventional

To determine whether the use of metformin in patients with low-risk prostate cancer can delay progression to clinically significant prostate cancer.

NCT ID: NCT01729676 Completed - Prostate Cancer Clinical Trials

Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation

FACT
Start date: May 2013
Phase: N/A
Study type: Observational

French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).

NCT ID: NCT01729442 Completed - Prostate Cancer Clinical Trials

Assessment of HIFU-induced Prostate Necrosis With Shear-wave Ultrasound Elastography

IDITOP-1
Start date: October 2012
Phase: N/A
Study type: Interventional

Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for prostate cancer that is currently assessed in two indications: as a first-line treatment (either total or focal) for patients who are not eligible for surgery and as a salvage treatment of local recurrences after radiotherapy. It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the position and volume of tissue destruction at the end of prostate HIFU ablation. This can provide live feedback regarding the amount of residual non ablated tissue after HIFU treatment, which could allow immediate re-treatment in case of unsatisfactory result. CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan, Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is necessary to wait 20 to 30 minutes before re-treating the patient. Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose of this study is to evaluate the accuracy of SWUE in depicting the position and volume of therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation. The present study is an exploratory, monocentric, prospective, descriptive study. Three groups of 10 patients with prostate cancer will be evaluated: patients referred for first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal treatment) and patients referred for salvage HIFU after radiotherapy. SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and D0 SWUE. The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by SWUE and CEUS. The secondary endpoints are: - The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0 and D+1, - Adverse events related to SWUE. The study will last 40 months.

NCT ID: NCT01727154 Terminated - Prostate Cancer Clinical Trials

Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

PRIME
Start date: October 2012
Phase:
Study type: Observational

The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

NCT ID: NCT01726894 Active, not recruiting - Prostate Cancer Clinical Trials

Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation

Nano
Start date: October 2013
Phase: N/A
Study type: Interventional

To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™).

NCT ID: NCT01724619 Terminated - Prostate Cancer Clinical Trials

Update and Biodistribution of [F-18]FMDHT pET/CT in Normal Healthy Volunteers and Patients With Metastatic Prostate Cancer - A First in Human Subject Study With [F-18] FMDHT

Start date: November 2012
Phase: Early Phase 1
Study type: Interventional

Prostate cancer represents a significant health problem in the United States. This year 179,000 men in the United States will be diagnosed with prostate carcinoma and approximately 25% of them will die of the disease. In addition, the incidence and mortality of prostate carcinoma has been increasing steadily in the United States. Prostate-specific antigen (PSA) levels are commonly used as a biomarker for the detection of prostate cancer. Nonetheless, there is a significant false negative and false positive diagnosis since PSA levels elevate in benign prostatic hyperplasia and prostatitis and decrease in patients taking medications and herbal remedies. Twenty percent of biopsy-proven prostate carcinoma have PSA levels within the normal range, thus confounding the diagnosis based on the PSA screening test. Current diagnostic methods that include transrectal ultrasound (TRUS) and TRUS guided prostate biopsy are logistically difficult and insensitive. These are further complicated by equivocal prostatic biopsy findings such as prostatic intraepithelial neoplasia (PIN) or normal PSA with high clinical suspicion. A tracer with high specificity to prostate cancer related structures at a cellular level would enhance our understanding of the pathophysiology of prostate cancer and would contribute to the detection, localization and quantification of the disease and its metastases. This information will be invaluable in selecting the appropriate treatment regimen. This study will test the utility of [F-18]FMDHT to image prostate cancer and will evaluate if this radiotracer can differentiate primary prostate cancer in the prostate gland from normal prostate gland itself. More specifically, we will study the distribution kinetics of [F-18]FMDHT in normal healthy humans and in patients with prostate cancer. As per exploratory IND requirements, we performed toxicity assessment of FMDHT through an outside laboratory (ILS, Inc.) and the results of that study are attached as Appendix A. Based on our and others data, we hypothesize that: 1. [F-18]FMDHT PET/CT will distribute initially in various normal tissues following blood flow pattern and will clear rapidly from tissues with no AR. 2. [F-18]FMDHT PET/CT will detect metastatic disease that expresses AR. 3. [F-18]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions compared to surrounding normal prostate. In order to progress [F-18]FMDHT into clinic, we are performing a pilot 'first-in-human' biodistribution study in subjects with and without prostate cancer.