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86 active trials for Prostatic Neoplasms

Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer

The goal of this study is to find out if patients with prostate cancer being treated with the medications abiraterone and prednisone can discontinue hormone injections (examples include leuprolide, goserelin, triptorelin and degarelix). Abiraterone and prednisone are pills used to treat patients with prostate cancer. When abiraterone and prednisone are used, hormone injections are usually continued to maintain a low testosterone level in the blood. This study is being done to find out if testosterone in the blood will stay low while abiraterone and prednisone are used without continued hormone injections.

Start: June 2018

Curative Image Guided Radiotherapy for Prostate Cancer

The clinical importance of cone beam computer tomography based image guided radiotherapy (CT- IGRT) has not been established. The primary aim of the present trial is to investigate whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as secondary outcome. An open randomised phase III trial. The included men will be randomised to receive curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm).

Start: October 2012

Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer

The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high metastatic load (1? visceral and ?4 osseous metastases) in respect to quality of life, reduction of side effects and possible reduction in tumor progression.

Start: April 2016

Biodistribution/Reproducibility Ga-68 PSMA-HBED-CC

The purpose of this Radioactive Drug Research Committee (RDRC) study is to collect initial data regarding biodistribution, reproducibility, and dosimetry for the radiotracer Ga-68 PSMA-HBED-CC, an agent which may be useful for the early detection of metastatic prostate cancer. Investigators will use a test and re-test design in all patients to determine reproducibility of lesion detection and signal intensity, and will include dynamic imaging in some patients for the purposes of dosimetry. Patients with known metastatic prostate cancer will be recruited and imaged on two occasions within the course of 15 days.

Start: July 2016

Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression

The purpose of this study is to determine whether marine omega-3 fatty acids and 5-alpha-reductase inhibitor are effective in the progression of prostate cancer for low-risk prostate cancer patients.

Start: November 2010

Dynamic Whole Body Positron Emission Tomography/Computed Tomography Imaging

Quantitative parameters obtained with dynamic whole body imaging using positron emission tomography (PET) can provide additional and complementary information to standard PET. Dynamic imaging allows for better understanding of the behavior of the radio-pharmaceutical because it can be followed over time. Thought to be difficult to perform with currently available clinical equipment that can affect the clinical workflow, it has recently shown to be feasible. We want to test the feasibility of this imaging technique and evaluate its utility in identifying lesions with three different radio-pharmaceuticals as compared to standard static PET. This study will also determine the clinical impact of DWB PET on participant management by comparing the overall qualitative assessment performed by nuclear medicine physicians between the standard PET images and the DWB ones.

Start: November 2019

PSMA PET/CT for Assessment of Recurrent Prostate Cancer

Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients will have their PC return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate-specific antigen (PSA) levels. This study proposes to use Fluorine-18-2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid (18F-DCFPyL) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the PC has recurred.

Start: March 2017

18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, [18F] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Start: February 2019

Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy

The purpose of this study is to see how well PROSTVAC -V/F works in stopping prostate cancer from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F.

Start: July 2016

Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy

The primary objective of this trial is to determine if adjuvant apalutamide in prostate cancer patients at high risk of developing subsequent metastatic disease results in prolonged biochemically recurrence-free survival after radical prostatectomy (RPE) in comparison to standard of care (SOC).

Start: December 2020

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.

Start: November 2015

Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer

Background: - Men who continue to have an elevated or rising prostate specific antigen (PSA) level after their primary prostate cancer treatment are at increased risk for their cancer to progress. The time it takes to progress is highly variable. One way to predict this progression is based on the change in PSA levels over time. This is called the PSA doubling time (PSADT). Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the PSA has become detectable again or has started to rise after primary treatment, but has not spread to other organs. Objectives: - To test a vaccine s effectiveness on the rate of PSA increase using PSADT and tumor growth rates. Eligibility: - Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months. Design: Participants will be screened with blood tests, scans, physical exam, and medical history. Their prostate cancer will be confirmed. Participants will undergo apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm. Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects. Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12, 15, and 24. Both will be made from the participants own cells. Participants will be selected randomly to receive either active vaccine or placebo. For every two participants assigned to active vaccine, one participant will be assigned to placebo vaccine. Participants will get a Vaccine Report Card to to complete after receiving vaccine. The study lasts 96 weeks.

Start: July 2015

Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139

Background: - Few studies or literature are available about the long-term safety of repeated peptide vaccinations in people over a period of time. Long-term vaccination may be needed to control tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they want to give those same men the new version of the vaccine. They want to see if it produces different types of immune responses and also ensure that repeated vaccinations are safe. Objectives: - To find out the long-term safety of repeated TARP peptide vaccinations. Eligibility: - Men who took part in NCI protocol 09-C-0139. Design: Participants will be screened with blood tests, scans, physical exam, medical history, and an evaluation of how well they perform everyday activities. Participants will have apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm. Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects. Participants will get vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine will be made from the participants own cells. Participants will get a Vaccine Report Card to complete after receiving vaccine. The study lasts 96 weeks.

Start: May 2015

Stereotactic Radiotherapy for Oligometastatic Prostate Cancer

This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.

Start: November 2014

Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT

This is a non-comparative open-label multicenter Phase 2 clinical trial combining stereotactic body radiation therapy (SBRT) and pembrolizumab with or without intratumoral SD-101 in patients with newly diagnosed hormone-naive oligometastatic prostate cancer.

Start: May 2018

Intestinal Microbiota in Prostate Cancer Patients as a Biomarker for Radiation-INduced Toxicity (IMPRINT)

Radiotherapy (RT) of the abdomen and/or pelvis is known to cause acute and late gastrointestinal (GI) toxicities. While radiation dose and volume are known risk factors for developing such side effects, recent evidence suggests patterns of disturbance in the composition of the GI microbiota - so called "dysbiosis" - may also promote the host's susceptibility to GI toxicities through impaired intestinal barrier function and inflammation. The IMPRINT-study aims to expand the current knowledge on the role of intestinal bacteria and their metabolites involved in the pathophysiology of radiation-induced GI toxicities by longitudinally examining the microbiota composition (feces), the associated metabolome (blood, feces and urine) and bacterial extracellular vesicles (BEVs) (blood and feces).

Start: August 2020

A Study of CC-90011 and Comparators in Participants With Prostate Cancer

This is an open-label, positron emission tomography (PET) imaging Proof of Biology (POB) study to determine whether CC 90011 reverses, by the induction of androgen receptor (AR) expression, the castration resistance, due to lineage switch, in participants with mCRPC that have failed enzalutamide as last prior therapy. This study aims to assess whether CC-90011 can induce AR expression and, consequently, re-sensitize tumors to anti-hormonal therapy.

Start: December 2020

Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance

To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring

Start: May 2020

Multiparametric MRI in Men With Prostate Cancer Undergoing Active Surveillance

Start: January 2013

A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase and is no longer enrolling. The Dose Expansion Phase currently has two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC). Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection Phase: Phase 1/2

Start: July 2014