Undergoing experimental therapy
with a new medication is a reasonable consideration when standard treatment is either no longer working or is causing unacceptable side effects.
However, it’s rare for doctors to recommend an experimental medication before other FDA-approved drugs on the market have been tried. The commercially available treatments already proven to extend survival are Lupron, Provenge, Xtandi, Zytiga, Xofigo, Taxotere and Jevtana.
PRINCIPAL INVESIGATOR Mark Scholz, MD
SUBINVESTIGATORS Richard Lam, MD + Jeffrey Turner, MD
STUDY COORDINATORS Micah + Sabrina
FOR MORE INFORMATION please contact our study coordinator, Sabrina 310.827.7707 or firstname.lastname@example.org
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. https://clinicaltrials.gov/ct2/show/study/NCT02407054?show_locs=Y#locn
- 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.
- 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. https://clinicaltrials.gov/ct2/show/NCT02380274
- 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 or second line treatment for CRPC; including anti-androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy, or radionuclide therapy. Previous first-line CRPC treatments are limited to first-generation anti-androgens or Sipuleucel-T. Patients may be enrolled within 90 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
- 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
- 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.
10TASQ10: A Phase III Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men Metastatic Castrate Resistant Prostate Cancer.
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. https://clinicaltrials.gov/ct2/show/study/NCT01234311
212082PCR3001: An Open Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed after Taxane-based Chemotherapy.
The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).
9785-CL-0401: A Multicenter, Single-arm, Open Label Treatment Protocol to Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy.
The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy. https://clinicaltrials.gov/ct2/show/record/NCT01606982
CA184-043: A Randomized, Double-blind, Phase III Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects with Castration Resistant Prostate Cancer that Have Received Prior Treatment with Docetaxel.
The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone.
CA184-095: A Randomized, Double-blind, Phase III Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer.
The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo. https://clinicaltrials.gov/ct2/show/NCT01057810
CC-5013-PC-002: A Phase III Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone with or without Lenolidomide in Subjects with Castrate-Resistant Prostate Cancer.
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects. https://clinicaltrials.gov/ct2/show/record/NCT00988208
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.
COU-AA-301: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy.
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel. https://clinicaltrials.gov/ct2/show/study/NCT00638690
COU-AA-302: A Phase III, Randomized, Double-blind, Placebo-controlled study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer.
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC). https://clinicaltrials.gov/ct2/show/study/NCT00887198
CRPC2: A Multinational Phase III, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy.
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
MDV3100-09: A Multicenter Phase 2, Randomized, Double-Blind, Efficacy and Safety Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer Who Have Failed Primary Androgen Deprivation Therapy.
The purpose of this study is to determine the safety and efficacy of enzalutamide vs. bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy. http://clinicaltrials.gov/ct2/show/NCT01664923
OGX-011-11: A Randomized Phase III Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate-Resistant Prostate Cancer.
This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms. https://clinicaltrials.gov/ct2/show/study/NCT01188187
OGX-011-12: A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY).
This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms. http://clinicaltrials.gov/ct2/show/record/NCT01578655
P11-3: A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC).
The purpose of this study is to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on product parameters of sipuleucel-T, and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer. https://clinicaltrials.gov/ct2/show/NCT01487863
P11-4: Immune Monitoring Protocol in Men with Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T.
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
P12-1: A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer.
The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases. https://clinicaltrials.gov/ct2/show/NCT01981109
PROCEDE-1000: An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients.
This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients. https://clinicaltrials.gov/ct2/show/NCT01954004
SIPIPI 2013: Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer.
This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer. https://clinicaltrials.gov/ct2/show/NCT01832870
SP005: A Randomized, Double Blind, Multicenter, Parallel-Group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy.
The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care Chemotherapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer.
TOK-200-15: A Phase 3, Randomized, Open Label, Multicenter, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant -7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC).
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
XL184-306: A Phase III, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) versus Mitoxantrone Plus Prednisone in Men with Previously Treated Symptomatic Castration-resistant Prostate Cancer.
This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC. http://clinicaltrials.gov/ct2/show/NCT01522443