Prostate Cancer

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Prostate Cancer Clinical TrialsGeneral Purpose:

Nearly a quarter of a million men in the United States will find themselves diagnosed with prostate cancer in 2012, and tens of thousands will die as a result of the disease. When detected and treated early, prostate cancer has a high survival rate, which is reassuring to many men who receive a diagnosis of prostate cancer. Prostate cancer clinical trials seeks to find new and better ways to detect and treat prostate cancer.

Also encouraging is the fact that there is a vast amount of research currently being conducted pertaining to all aspects of prostate cancer. Research is aimed at identifying what causes prostate cancer to develop, as well as better methods to prevent, screen, and diagnose the disease.

Additionally, an extremely active area of prostate cancer research focuses on improving existing treatments in order to minimize unwanted side effects, such as impotency, as well as developing more effective methods of delivering radiation therapy, chemotherapy, and hormone therapy.

What Will Prostate Cancer Clinical Trials Be Like?

When participating in a prostate cancer clinical trial, there are a few basic tests and procedures you may receive; however, the ultimate design of the particular study will determine which specific procedures you will undergo. Some of the following tests and procedures may be used during prostate cancer clinical trials:

  • Physical exam and detailed family history information
  • Digital rectal exam (DRE)
  • Blood test to measure the amount of prostate-specific antigen (PSA) in the blood.prostate cancer clinical trials PSA is found in increased amounts among men who have prostate cancer, and is often used as part of screening efforts to detect the presence of prostate cancer, as well as to monitor the effects of treatment.
  • Blood and/or tissue sample for the purposes of conducting genetic testing.
  • If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
  • Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.
  • Imaging procedures such computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.   
  • Ultrasound
  • Biopsy

Typical Protocol for Prostate Cancer Clinical Trials:

Prostate cancer research is abundant, in terms of the numbers of clinical trials currently underway, as well as the breadth and depth of topics being investigated. Sample clinical trials might include the following:

  • A clinical trial evaluating men with prostate cancer who have a specific grouping of genetic mutations as well as men with prostate cancer who do not have those same mutations in order to determine if a) those with the genetic mutations have a poorer response to standard treatment and b) those with the genetic mutations are more likely to have their disease spread to other sites of the body.
  • A long-term study designed to evaluate if a high intake of vitamin D places him at a lower risk of developing prostate cancer.
  • A clinical trial designed to evaluate if a man’s blood level of calcium has an impact (either positively or negatively) on how they respond to chemotherapy for prostate cancer.
  • A study designed to determine if the use of specific hormonal medications can reduce the risk of prostate cancer in African American men with a family history of the disease.
  • A clinical trial designed to compare two separate types of PSA testing to determine which one more accurately detects the presence of prostate cancer.
  • A clinical trial designed to evaluate a newer, more targeted method of delivering radiation therapy to the prostate in order to determine if a) it more effectively treats prostate cancer than standard radiation therapy delivery methods and b) if it results in fewer radiation-related side effects.
  • A clinical trial comparing standard chemotherapy for prostate cancer to a new combination of chemotherapy drugs to determine a) which has a greater impact on the growth of the cancer and b) which has fewer side effects.

A brief word about randomized trials and placebos:

Many clinical trials, like prostate cancer clinical trials, involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy prostate cancer clinical trialsa patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

The type of prostate cancer clinical trials you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when prostate cancer clinical trialssearching for clinical trials. Examples of the details you will want to have on hand include:

  • The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

Suggested Search Terms:

“prostate cancer treatment,” “prostate cancer chemotherapy,” “prostate cancer radiation therapy,” “prostate cancer management,” “prostate cancer surgery,” “advanced prostate cancer,” “prostate cancer hormone therapy,” “prostate cancer watchful waiting,” “prostate cancer diet,” “prostate cancer screening,” and “prostate cancer side effects,” “prostate cancer clinical trials.”

Current Search Term:

“Prostate Cancer”

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Repurposing Metformin as Anticancer Drug: in Advanced Prostate Cancer

Condition:   Prostate Cancer
Intervention:   Drug: Metformin
Sponsor:   Mansoura University
Recruiting - verified April 2017

A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer

Condition:   Prostate Cancer
Interventions:   Drug: Leuprolide Acetate;   Drug: Prednisone;   Drug: Docetaxel;   Drug: Apalutamide
Sponsors:   Dana-Farber Cancer Institute;   Janssen Pharmaceutica
Not yet recruiting - verified April 2017

Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy

Condition:   Prostate Cancer
Intervention:   Other: Exercise Intervention
Sponsor:   Dana-Farber Cancer Institute
Not yet recruiting - verified May 2017

Nivolumab in Prostate Cancer With Mutations in DNA Repair Defects (ImmunoProst Trial)

Condition:   Prostate Cancer
Intervention:   Drug: Nivolumab
Sponsors:   Hospital Moinhos de Vento;   Bristol-Myers Squibb
Not yet recruiting - verified January 2017

ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

Condition:   Prostate Cancer
Interventions:   Drug: ODM-201;   Drug: ADT
Sponsors:   European Organisation for Research and Treatment of Cancer - EORTC;   Bayer
Not yet recruiting - verified November 2016

Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy

Condition:   Prostate Cancer
Interventions:   Drug: Apalutamide;   Drug: Leuprolide;   Drug: Prednisone;   Drug: Abiraterone Acetate;   Procedure: Radical Prostatectomy;   Other: Observation-Post RP
Sponsors:   Dana-Farber Cancer Institute;   Janssen Scientific Affairs, LLC
Recruiting - verified May 2017

Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers

Condition:   Prostate Cancer
Intervention:   Other: Prostate MRI
Sponsor:   Turku University Hospital
Recruiting - verified July 2016

A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

Condition:   Prostate Cancer
Interventions:   Drug: LY2452473;   Drug: Placebo
Sponsors:   Dana-Farber Cancer Institute;   National Institute of Nursing Research (NINR)
Recruiting - verified May 2017

Evaluation of Diet and Exercise in Prostate Cancer Patients

Condition:   Prostate Cancer
Sponsors:   AbbVie;   Canadian Urology Research Consortium;   JSS Medical Research Inc.;   CMX Research
Recruiting - verified April 2017

Early Changes In Multiparametric MRI In Prostate Cancer

Condition:   Prostate Cancer
Interventions:   Device: MRI;   Other: PSA Blood Test
Sponsors:   Dana-Farber Cancer Institute;   National Institutes of Health (NIH)
Active, not recruiting - verified January 2017

UK Genetic Prostate Cancer Study: Epidemiology and Molecular Genetics Studies

Condition:   Prostate Cancer
Sponsors:   Institute of Cancer Research, United Kingdom;   Cancer Research UK;   Royal Marsden NHS Foundation Trust
Recruiting - verified August 2016

Phase II Study to Evaluate Conventional Radiation Therapy Followed by Radiosurgical Boost in Clinically Localized Prostate Cancer

Condition:   Prostate Cancer
Intervention:   Radiation: Radiotherapy with IMRT and CyberKnife Boost
Sponsor:   Georgetown University
Active, not recruiting - verified May 2017

Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study

Condition:   Prostate Cancer
Sponsors:   AbbVie (prior sponsor, Abbott);   CMX Research;   JSS Medical Research Inc.
Completed - verified September 2016

Stereotactic Body Radiotherapy for Prostate Cancer

Condition:   Prostate Cancer
Intervention:   Radiation: stereotactic body radiotherapy
Sponsor:   Mercy Research
Recruiting - verified March 2017

S9346A Blood Samples From Patients With Metastatic Prostate Cancer Previously Treated With Bicalutamide and Goserelin

Condition:   Prostate Cancer
Interventions:   Genetic: gene expression analysis;   Genetic: polymorphism analysis;   Other: laboratory biomarker analysis
Sponsors:   Southwest Oncology Group;   National Cancer Institute (NCI)
Completed - verified October 2016

Prostate Cancer Symptom Management for Low Literacy Men

Condition:   Prostate Cancer
Interventions:   Behavioral: PC-PEP - Prostate Cancer Patient Education Program;   Behavioral: Usual care
Sponsors:   Baylor College of Medicine;   American Cancer Society, Inc.;   Michael Debakey Veterans Affairs Medical Center
Active, not recruiting - verified November 2016

Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

Condition:   Prostate Cancer
Interventions:   Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE;   Radiation: Proton (prostate bed) to 70.2 CGE;   Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE;   Radiation: Proton to 66.6 CGE
Sponsor:   University of Florida
Recruiting - verified March 2017

Prostate Cancer Prospective Cohort

Condition:   Prostate Cancer
Sponsors:   Washington University School of Medicine;   Johns Hopkins University;   National Cancer Institute (NCI);   Wake Forest University
Recruiting - verified April 2017

Study of 2 Different Doses of Revlimid in Biochemically Relapse Prostate Cancer

Condition:   Prostate Cancer
Intervention:   Drug: Revlimid
Sponsors:   Sidney Kimmel Comprehensive Cancer Center;   Celgene Corporation
Completed - verified June 2016

Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer

Condition:   Prostate Cancer
Interventions:   Dietary Supplement: calcitriol;   Drug: mitoxantrone hydrochloride;   Drug: prednisone
Sponsors:   OHSU Knight Cancer Institute;   National Cancer Institute (NCI)
Completed - verified May 2017

Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer

Condition:   Prostate Cancer
Intervention:   Drug: 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)
Sponsor:   Weill Medical College of Cornell University
Completed - verified February 2017

Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer

Condition:   Prostate Cancer
Interventions:   Drug: Pemetrexed;   Dietary Supplement: Folic Acid;   Dietary Supplement: Vitamin B12
Sponsors:   Christopher Sweeney, MBBS;   Eli Lilly and Company;   Walther Cancer Institute
Completed - verified June 2016

Lycopene in Treating Patients With Metastatic Prostate Cancer

Condition:   Prostate Cancer
Intervention:   Dietary Supplement: lycopene
Sponsors:   Alliance for Clinical Trials in Oncology;   National Cancer Institute (NCI)
Completed - verified July 2016

Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels

Condition:   Prostate Cancer
Interventions:   Dietary Supplement: soy protein isolate;   Dietary Supplement: casein proteins
Sponsors:   Alliance for Clinical Trials in Oncology;   National Cancer Institute (NCI)
Completed - verified July 2016

Green Tea Extract in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Condition:   Prostate Cancer
Intervention:   Dietary Supplement: green tea extract
Sponsors:   Alliance for Clinical Trials in Oncology;   National Cancer Institute (NCI)
Completed - verified July 2016

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