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Clinical Trials

CRILA: The Effect of Crila® Prostate Herb to Support Prostate Health

Crila®, a proprietary plant extract from Vietnam, appears to have properties that support the body's natural inflammatory response function. The purpose of this study is obtain more objective information about the effects of Crila® for men with urinary symptoms.

Inclusion Criteria:

  • Male patient 18 years or older
  • Willing and able to provide informed consent
  • AUA score ≥ 10
  • Willing and able to complete monthly office visits and study assessments (bloodwork, urinalysis, color Doppler ultrasound)
  • Willing and able to complete monthly AUASS/QoL and OABSS questionnaires
  • Must stay on same concomitant medications throughout the entire course of Crila® treatment

Exclusion Criteria:

  • Morbid Obesity

GU 115 Eli Lilly: A Double-Blinded, Placebo-Controlled, Randomized Phase II Study of Enzalutamide With or Without the PI3 Kinase/mTOR Inhibitor LY3023414 in Men with Metastatic Castration Resistant Prostate Cancer

The primary objective of this study is to compare progression-free survival in men with mCRPC who are receiving enzalutamide plus LY3023414 versus enzalutamide plus placebo using Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
  • Metastatic disease documented by positive bone scan or metastatic lesions on CT, MRI.If lymph node metastasis is the only evidence of metastasis, it must be ≥ 2 cm in diameter.
  • Prostate cancer progression documented by PSA and/or radiographic progression according to PCWG2 criteria
  • Prior abiraterone treatment completed at least 2 weeks prior to Cycle 1 Day 1.
  • If patient has previously been treated with RA-223 dichloride, treatment must be completed at least 4 weeks prior to Cycle 1 Day 1 (minimum 4 week wash out period).
  • If a patient was treated with abiraterone, but their last treatment prior to enrollment was an anti-androgen as last treatment prior to enrolment, PSA or symptomatic progression will need to be documented.
  • Patients whose PSA did not decline for 3 or more months in response to an anti-androgen given as a second line or later intervention will require only a 2-week washout prior to Cycle 1 Day 1.
  • Surgically or medically castrated, with testosterone levels of < 50 ng/dL. If the patient is being treated with LHRH agonists (patients who have not undergone orchiectomy), this therapy must be continued throughout the study.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Able to swallow the study drugs whole
  • Adequate hematologic function defined as:
    • Absolute neutrophil count (ANC) ≥1500/μL
    • Platelets ≥100,000/μL
    • Hemoglobin ≥8 g/dL
  • Adequate liver function defined as:
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN). If the liver has tumor involvement, AST and ALT equaling ≤5 times ULN are acceptable.
    • Total bilirubin ≤1.5 x ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)
  • Adequate renal function defined as serum creatinine < 1.5 x ULN OR creatinine clearance > 45 mL/min by Cockcroft-Gault formula for patients with serum creatinine > 1.5x ULN.
  • Adequate coagulation parameters, defined as International Normalization Ratio (INR) ≤ 2. Patients with history of blood clot may receive anticoagulation with low molecular weight heparin, central line prophylaxis-dose warfarin, or anti-factor Xa agents.
  • Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 3 months after last study drug administration.
  • Male, Age ≥ 18 years.
  • Willingness and ability to comply with study and follow -up procedures.
  • Ability to understand the nature of this study and give written informed consent.
  • Availability of tumor tissue (formalin-fixed paraffin-embedded [FFPE] blocks) or unstained slides from any time since diagnosis of prostate cancer disease (i.e., archival tumor samples). If no tumor samples are available the patient might still be eligible following discussion between the investigator and the Medical Monitor.

Exclusion Criteria:

  • Patients that have received the following prior treatments for CRPC
    • Prior cytotoxic chemotherapy Note: Patients may have received docetaxel in the hormone-sensitive setting.
    • PI3K/AKT /mTOR agent (including TORC1 and TORC2 inhibitors) for the treatment of CRPC.
    • Immune checkpoint inhibitors (e.g. inhibitors of CTLA4, PD1, PDL1)
    • Prior investigational new generation potent anti-androgen therapy (such as ARN509).
    • Prior treatment with enzalutamide.
  • Pathological finding consistent with small cell carcinoma of the prostate.
  • Concurrent use of another investigational agent(s).
  • Prior systemic treatment with an azole drug (fluconazole, itraconazole) within 4 weeks of Cycle 1 Day 1.
  • Known brain metastasis.
  • History of (a) seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma); (b) loss of consciousness or transient ischemic attack within 12 months prior to Day 1 of Cycle 1.
  • Uncontrolled hypertension (systolic blood pressure [BP] ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed, provided blood pressure is controlled by anti-hypertensive treatment.
  • Have serious pre-existing medical conditions (at the discretion of the investigator).
  • Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and Medical Monitor, may affect the interpretation of results.
  • Have insulin-dependent diabetes mellitus. Patients with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by HbA1c <7%.
  • Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2, and malabsorption syndrome).
  • Have a history of New York Heart Association (NYHA) Class ≥3, QTc interval > 450 ms on screening electrocardiogram (ECG) per Friderica's formula at several consecutive days of assessment, unstable angina, or myocardial infarction (MI) in 6 months prior to study drug administration.
  • Clinically significant electrolyte imbalance ≥ Grade 2.
  • Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin and oral Xa inhibitors are allowed.
  • Have initiated treatment with bisphosphonates or approved RANK ligand (RANK-L) targeted agents (e.g. denosumab) ≤28 days prior to Day 1 of Cycle 1.
  • Concurrent serious infections requiring parenteral antibiotic therapy.
  • Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results.
  • Have an active, known fungal, bacterial, and/or known viral infection including:
    • Human immunodeficiency virus (HIV) (screening not required)
    • Hepatitis A (screening not required)
    • Hepatitis B or C (screening not required).
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.

ONC-MA-1004 TRUMPET: A Prospective Observational Cohort Study of Patients with Castration-Resistant Prostate Cancer (CRPC) in the United States

The purpose of this study is to describe patterns of care and disease assessment method, as well as to identify factors influencing physician treatment decisions and settings, referral patterns and CRPC patient characteristics associated with these. This study will also describe factors influencing treatment decisions including reason(s) for treatment choices and triggers for treatment changes for CRPC as well as describe clinical outcomes based on patient characteristics.

Inclusion Criteria:

  • Confirmed diagnosis of CRPC (defined by a minimum of two rising PSA levels to be measured at least 7 days apart, and serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) or with new evidence of metastatic disease by investigating physician
  • Initiating the first active course of anti-cancer treatment for M0 CRPC or for M1 CRPC (regardless of prior M0 CRPC treatment) such as anti-androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. Patients may be enrolled within 45 days from the time of treatment initiation.
  • Willing and able to complete periodic patient-reported outcome (PRO) questionnaires, with or without assistance
  • Estimated life expectancy of ≥ 6 months

Caregiver Inclusion:

  • Meets the definition of an unpaid relative or friend who helps the patient with his or her activities of daily living
  • Willing and able to complete caregiver-reported outcome questionnaires over the course of the patient's participation in the study

Exclusion Criteria:

  • Currently enrolled in any interventional clinical trial with a non-approved investigational agent for the primary disease of CRPC at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the study)
  • Receiving concomitant treatment for other cancer (excluding basal cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment.