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Highlighted Prostate Cancer Trials and Studies

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

Rising PSA post-initial treatment

Psycho/social

Multiple trials

TRIAL DESCRIPTIONS

Organ confined/localized

  • PCa003 Study - An investigational clinical study of Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions; PCa003 is currently enrolling men with Gleason 7 prostate cancer.

    INSIGHTEC is seeking men with Gleason 7 prostate cancer to participate in a clinical trial of an investigational device for prostate lesions. The Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions Study (PCa003) is a clinical trial currently enrolling men over 50 who have intermediate-risk, organ confined prostate cancer who have not had prior localized treatment for prostate cancer. All patients who qualify will undergo the investigational procedure and follow-up for 24 months post-treatment.

    To learn more about the PCa003 study and to find out if you may be eligible, please visit: https://www.insightec.com/clinical/urology or https://clinicaltrials.gov/ct2/show/NCT01657942?term=Exablate+prostate&rank=3

    Study Identifier: NCT01657942
    INSIGHTEC Ltd.

Rising PSA post-initial treatment

  • 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 AND Metastatic:

Metastatic

Men with metastatic castration-resistant prostate cancer are invited to consider enrollment in one of two international, Pfizer-sponsored studies of talazoparib:

  • TALAPRO-1: A phase 2, open-label study of talazoparib in men with DNA damage repair (DDR)-deficient metastatic castration-resistant prostate cancer (mCRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal therapy (NHT) NCT03148795

  • TALAPRO-2: A phase 3, randomized, double-blind, placebo-controlled study of talazoparib with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) NCT03395197

    For an overview of these studies in patient-friendly language, visit: talaprotrials.com

  • The GALAHAD Study – A clinical research study now enrolling men in the US who have metastatic castration‐resistant prostate cancer and DNA‐repair anomalies (Enrollment deadline: January 2019)

  • Janssen Research & Development is seeking men in the US to participate in a clinical trial of an oral investigational medication for prostate cancer. All participants will receive daily investigational medication. To learn more about the Galahad study and find out if you may be eligible, please visit: www.clinicaltrials.gov Study Identifier: NCT02854436
    Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

  • Social Support and Cancer Survey

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.

    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).