Highlighted Prostate Cancer Trials and Studies  

Search for Prostate Cancer Clinical Trials

As part of Us TOO’s continued commitment to bring news of new interventions and treatments for the benefit of prostate cancer patients, we are pleased to share this news with you about the following opportunities to participate in clinical trials.

Organ confined/localized

  • We are not aware of any trials in this category at this time

Locally advanced

Rising PSA post-initial treatment

Hormone refractory/hormone resistant

Hormone refractory/hormone resistant AND Metastatic:

Metastatic

Psycho/social

Multiple trials


TRIAL DESCRIPTIONS

Organ confined/localized

  • We are not aware of any trials in this category at this time



Locally advanced

  • A Trial of Combined Cryotherapy and Intra-tumoral Immunotherapy with Autologous Immature Dendritic Cells (VDC2008) in Chemo-naďve Men with Prostatic Adenocarcinoma and Limited Metastases to Lymph Nodes and/or Bone (The “CRITICAL” Trial)


  • The purpose of this study is to determine whether intra-tumoral injection of subject’s own dendritic cells after cryotherapy of the prostate is safe and effective in the treatment of advanced prostate cancer. In theory, injected dendritic cells will internalize antigens from tumor cells damaged by cryotherapy and facilitate the initiation of a tumor-specific immune response. Subjects will also receive a low dose regimen of cyclophophamide pre- and post- cryotherapy to selectively reduce number of regulatory T cells (Treg), which have been implicated in dampening or halting immune responses. Using this combination of therapies, it is thought that a clinically significant anti-cancer immune response might be elicited.

    Click Here for clinical trials.gov listing with more information about this study

  • Cancer Vaccine Trial: A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer

    Stage D0 prostate cancer patients have no evidence of visceral or bony metastatic disease but have persistently elevated or rising PSA levels (biochemical progression) and are at increased risk for disease progression. TARP (T-cell receptor alternate reading frame protein) is expressed by both normal and malignant prostate cancer tissue and is found in about 95% of prostate cancer specimens. TARP is immunogenic and hence is a target antigen for vaccination. 

    Dr. Jay A. Berzofsky, Principal Investigator

    Read here for Cancer Vaccine Trial details


Rising PSA post-initial treatment

  • Phase II Trial of an Adenovirus/PSA Vaccine for Recurrent Prostate Cancer [012010]

    The University of Iowa and the Iowa City VA Medical Center are conducting a Phase II trial of a vaccine for the treatment of recurrent prostate cancer. Two protocols are active; one protocol treats hormone naďve patients who have experienced a recent, but continued rise in their serum PSA following initial treatment for their prostate cancer, and a second protocol treats men with hormone refractory prostate cancer. The hypothesis is that the vaccine will induce the production of anti-PSA and, therefore, anti-prostate cancer, immune responses that will cause the destruction of the cancer cells anywhere in the body.

    Interested patients can contact the Clinical Trial Coordinator Ms. Pamela Zehr at 319-353-8914, pamela-zehr@uiowa.edu or Dr. David Lubaroff at 319-335-8423, david-lubaroff@uowa.edu.

    Click Here for clinicaltrials.gov listing with more information about this study

  • IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

    The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.

    Inclusion Criteria:

    • Currently receiving and must have had continuous therapy with Gonadotropin-releasing hormone (GnRH) monotherapy for at least 6 months before screening, with a serum testosterone of < 50 nanograms/deciliter (< 2.0 nanograms per milliliter) or have undergone surgical removal of the testicles with a blood testosterone level of < 50 nanograms per deciliter (<2.0 nanograms per millimeter)

    • Have rising Prostate Specific Antigen (PSA) after local therapy and treatment with GnRH monotherapy (defined as a PSA of greater than or equal to 10 nanograms/milliliter obtained at screening or PSADT (prostate-specific antigen doubling time) of < or equal to 6 months with a baseline PSA of greater than or equal to 2.0 nanograms/milliliter)

    Exclusion Criteria:

    • Have prior or current evidence of local disease progression or metastatic disease as defined by modified response evaluation criteria in solid tumors (RECIST) criteria

    • Have received chemotherapy for treatment of castrate-resistant prostate cancer

    • Have a Prostate Specific Androgen Doubling Time (PSADT) of greater than 15 months

    http://www.clinicaltrials.gov/ct2/show/NCT01314118?term=prostate+cancer%2Cabiraterone&rank=19 




Hormone refractory/hormone resistant

  • Phase II Trial of an Adenovirus/PSA Vaccine for Recurrent Prostate Cancer [012010]

    The University of Iowa and the Iowa City VA Medical Center are conducting a Phase II trial of a vaccine for the treatment of recurrent prostate cancer. Two protocols are active; one protocol treats hormone naďve patients who have experienced a recent, but continued rise in their serum PSA following initial treatment for their prostate cancer, and a second protocol treats men with hormone refractory prostate cancer. The hypothesis is that the vaccine will induce the production of anti-PSA and, therefore, anti-prostate cancer, immune responses that will cause the destruction of the cancer cells anywhere in the body.

    Interested patients can contact the Clinical Trial Coordinator Ms. Pamela Zehr at 319-353-8914, pamela-zehr@uiowa.edu or Dr. David Lubaroff at 319-335-8423, david-lubaroff@uowa.edu.

    Click Here for clinicaltrials.gov listing with more information about this study

  • Cancer Vaccine Trial: A Randomized Phase II Trial Combining Vaccine Therapy With PROSTVAC/TRICOM and Flutamide vs. Flutamide Alone in Men With Androgen Insensitive, Non-Metastatic (D0.5) Prostate Cancer

    Many men receiving hormonal therapy for prostate cancer develop a rising PSA but have no evidence of disease on bone scan or CT scan. Currently, there is no standard of care for these patients. In a prior clinical study, we showed preliminary clinical data that combining hormone therapy with a vaccine targeting PSA may benefit patients with this stage prostate cancer. In our current trial, patients will be randomized to receive either flutamide alone (an FDA-approved pill that is active in prostate cancer) or in combination with a prostate cancer vaccine to determine if the addition of the vaccine can improve the outcome (prolong disease progression) compared with flutamide alone. The study will also seek to understand the immunologic effects of these treatments.

    Dr. Ravi A. Madan, Principal Investigator

    Read here for Cancer Vaccine Trial details

  •  

Hormone refractory/hormone resistant AND Metastatic:

  • 2 Metastatic PCa Studies for Investigational Oral Medication Now Enrolling Participants: Chemotherapy naive for metastatic disease and Post-Chemotherapy

    Two global research studies, called the elm•pc studies, are seeking men with metastatic castration-resistant prostate cancer to participate in the effort to evaluate a new investigational oral medication, TAK-700, given with prednisone.

    The studies will help determine if TAK-700, given with prednisone, can lengthen the lives of men with metastatic castration-resistant prostate cancer compared to prednisone alone.

    Men enrolled in either study will be assigned to one of two groups: those who will receive the investigational oral medication, TAK-700, with prednisone, and those who will be treated with prednisone alone. Prednisone is asteroid commonly used to treat advanced prostate cancer.

    TAK-700, an investigational oral lyase inhibitor, is being studied for individuals with metastatic prostate cancer.

    The elm•pc studies are being conducted by Millennium: The Takeda Oncology Company. To learn more about the elm•pc studies call 1-855-493-5672 or visit www.elmpctrials.com.

  • Cancer Vaccine Trial: A Randomized Phase 2.5 Study of [153]Sm-EDTMP (Quadramet) With or Without a PSA TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer

    Previous studies have shown that PSA-TRICOM vaccines can stimulate immune and clinical responses in patients with metastatic prostate cancer. However, many cancer cells seem to be able to evade this immune response. The goal of this trial is to see if vaccine with Quadramet can improve time to disease progression compared with Quadramet alone.

    Dr. James L. Gulley, Principal Investigator

    Read here for Cancer Vaccine Trial details



Metastatic

  • Ongoing enrollment for asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer (mCRPC) patients across as many as 250 clinical trial centers and up to 15 countries

    More information can be found on clinicaltrials.gov, or the study website www.continueyourfight.com

  • 2 Metastatic PCa Studies for Investigational Oral Medication Now Enrolling Participants: Chemotherapy naive for metastatic disease and Post-Chemotherapy

    Two global research studies, called the elm•pc studies, are seeking men with metastatic castration-resistant prostate cancer to participate in the effort to evaluate a new investigational oral medication, TAK-700, given with prednisone.

    The studies will help determine if TAK-700, given with prednisone, can lengthen the lives of men with metastatic castration-resistant prostate cancer compared to prednisone alone.

    Men enrolled in either study will be assigned to one of two groups: those who will receive the investigational oral medication, TAK-700, with prednisone, and those who will be treated with prednisone alone. Prednisone is asteroid commonly used to treat advanced prostate cancer.

    TAK-700, an investigational oral lyase inhibitor, is being studied for individuals with metastatic prostate cancer.

    The elm•pc studies are being conducted by Millennium: The Takeda Oncology Company. To learn more about the elm•pc studies call 1-855-493-5672 or visit www.elmpctrials.com.

  • ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain [071108]

    InSightec Ltd. is conducting an FDA approved phase III pivotal study (BM004) to evaluate the effectiveness and safety of ExAblate (MR guided Focused Ultrasound, MRgFUS) for the palliation of pain from metastatic bone tumors in patients who are not suitable candidates to receive additional radiation therapy. ExAblate MRgFUS uses (focused) ultrasound to treat tissue without surgical cutting (i.e. non-invasive procedure). The ExAblate use for the palliation of pain from bone metastases is experimental. The study hypothesis is that ExAblate is safe and effective in the treatment of pain resulting from metastatic bone tumors in patients that did not respond to radiation treatment or who are otherwise unsuitable for radiation treatment, with a low incidence of co-morbidity.

    This clinical trial is open for enrollment at study sites nationwide. 

    Click Here for a study summary and a list of participating sites.
    Click Here for more information about the studies and about bone metastases


Psycho/social

  • NCI-supported Healing Choices Study for Newly Diagnosed Prostate Cancer Patients

    Have you recently been diagnosed with prostate cancer? If so, then you have a lot to think about. For example, you need to know what your treatment options are and how these treatment options will affect your life.

    Though your doctor probably mentioned treatment options when you received your diagnosis, the information can be difficult to understand at this emotional time. Once you've had time to get over the initial shock of a diagnosis, you'll have questions about your treatment and want some answers. That's what the Healing Choices Study is all about.

    Healing Choices for Prostate Cancer is a study dedicated to finding out the best way to help men like you get important information about prostate cancer; information that will help you make the treatment decision that's right for you.

    If you have not yet decided on a treatment, we urge you to call us and take part in the study.

    This study is non-partial and unbiased. No surgical practice or pharmaceutical company has anything to gain. Conducted by University of Colorado Cancer Center, Fox Chase Cancer Center, Mount Sinai School of Medicine, and the University of California, Los Angeles (UCLA) and funded by the National Cancer Institute, Grant Number P01 CA057586-09A2, the only purpose of this study is to help you make decisions that are right for you and that reflect your values. To find out how useful the study was to you, we will call you twice during the next nine months to ask you a few questions. 

    To participate in the Study, call toll-free: 1-866-258-7981.

    Our recruitment team will ask you several questions to find out if you're eligible to participate in the study. 
    You can join the Healing Choices study if you match ALL of these MAIN categories (more will be discussed by the recruitment team):
    • You were recently diagnosed with Stage I, II or III prostate cancer 
    • Have not yet started your prostate cancer treatment (e.g., surgery, radiation therapy, active surveillance or watchful waiting).
    • No history of previous cancer 
    • You are over 18 years old
    • You are able to speak and understand English 
    • You live is USA or Canada 
    • You have access to a computer 

    If you are eligible:

    • you will be mailed a variety of important and helpful information on prostate cancer options -- ranging from printed materials to multimedia CD-ROMs.
    • you will receive a follow-up phone call in 6 months 
    • you will receive a follow-up phone call in 9 months

    The three phone calls will take an average of 20 minutes, total. All information is totally confidential and will not be shared outside the study team. 

    If you are not eligible:

    • we will give you a list of phone numbers and websites where you can find answers to your questions about prostate cancer.

    For more information about the study, please see: http://www.prostatehealingchoices.com/index.php 

    Participation deadline is December 2011.

  • Australian Prostate Cancer and Sexual Activity Survey

    The Australian Research Centre in Sex, Health and Society at La Trobe University, Melbourne, Australia is conducting an international survey of men’s experiences of sexual activity following treatment for prostate cancer. The information collected will be used to develop programs to help prostate cancer patients remain sexually active after prostate cancer treatment. 

    The survey comprises questions related to background, sexual identity, relationship status, prostate cancer treatment, and questions specific to sexual practice before and after treatment. It should take between 20-30 minutes to complete and is entirely anonymous. This project has received ethics approval from the La Trobe University Human Ethics Committee. 

    If you have been treated for prostate cancer, we hope you’ll participate in this important survey. The survey is anonymous and should take between 20-30 minutes to complete. 

    The survey can be found at www.prostatecancerandsexuality.net 

    For questions or more information, contact:

    Professor Gary Dowsett, Chief Investigator, on behalf of Co-Investigators 
    Professor Marian Pitts
    Professor Richard Wassersug
    La Trobe University
    215 Franklin St
    Melbourne
    Victoria 3000
    Australia
    T +61 3 9285 5382
    F +61 3 9285 5220

    Division of Health Research
    Faculty of Health Sciences

  • Social Support and Cancer Survey

    Researchers at Virginia Commonwealth University are conducting a survey of individuals who have been diagnosed with cancer in order to understand use of different social support resources. If you are over age 21 and have been diagnosed with cancer, you are eligible to complete a 30-minute survey about your experiences using web-based and other tools or support groups. Please follow this link for more information and to participate in the survey: http://tinyurl.com/SupportSurveyVCU.

    For questions or more information, contact:

    Jessye Cohen, M.S.
    Doctoral Student, Counseling Psychology
    Virginia Commonwealth University
    s3jcohen@mymail.vcu.edu

Multiple trials

  • Prostate cancer trials at the NIH Clinical Center in Bethesda, MD [080706]

    NCI currently conducting trials for patients with prostate cancer -- The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), conducts more than 150 clinical trials at the NIH Clinical Center in Bethesda, MD. NCI is currently conducting clinical trials for patients with prostate cancer.

    Visit http://bethesdatrials.cancer.gov/prostate for a listing of prostate cancer clinical trials that are currently enrolling patients at the NIH Clinical Center.

    There is no charge for medical care received at the NIH Clinical Center. Study participants will be responsible for travel costs for their initial screening visits. Once participants are enrolled in a trial, NCI will pay for the transportation costs for all subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients.

    For more information on clinical trials conducted at NCI, please visit http://bethesdatrials.cancer.gov or call the Clinical Trials Referral Office (formerly Clinical Studies Support Center) at 1-888-NCI-1937 (1-888-624-1937). 

    The National Cancer Institute also sponsors clinical studies at cancer centers nationwide. To learn more about these studies, call 1-800-4-CANCER (1-800-422-6237).



 
 

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