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Prostate Cancer clinical trials

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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: 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.

NCT ID: NCT01717677 Terminated - Prostate Cancer Clinical Trials

Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

PREFERE
Start date: October 2012
Phase: N/A
Study type: Interventional

4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk

NCT ID: NCT01709734 Terminated - Prostate Cancer Clinical Trials

A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer

ARMOR2
Start date: December 2012
Phase: Phase 2
Study type: Interventional

A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.

NCT ID: NCT01705652 Terminated - Prostate Cancer Clinical Trials

Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients

Nexrutine
Start date: July 2011
Phase: Phase 2
Study type: Interventional

The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. The Secondary Objective is to confirm the tolerability of this regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of Nexrutine®. Molecular response is defined as changes in the molecular pathways.

NCT ID: NCT01705405 Terminated - Prostate Cancer Clinical Trials

Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

FEE
Start date: October 2012
Phase: N/A
Study type: Interventional

Visualize surgical needles inserted in the prostate, under the ultrasound modality.

NCT ID: NCT01704027 Terminated - Prostate Cancer Clinical Trials

Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer

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

The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer

NCT ID: NCT01699672 Terminated - Breast Cancer Clinical Trials

Group-based or Individual Information About Disease and Treatment Plan

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

The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment. Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.

NCT ID: NCT01681433 Terminated - Prostate Cancer Clinical Trials

OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone

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

This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to continuing abiraterone acetate and prednisone treatment in men with metastatic castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA) progression

NCT ID: NCT01677845 Terminated - Prostate Cancer Clinical Trials

Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

Start date: May 2012
Phase: Phase 1
Study type: Interventional

The aim of this study is to determine the maximum tolerated dose of hypo-fractionated radiation therapy and the toxicity of the treatment program. Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT). Dose escalation will be as follows: There will be 3 cohorts consisting of 3 patients each.