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 Staff

FOR MORE INFORMATION please contact our study coordinator 310.827.7707 or mail@prostateoncology.com


ACTIVE TRIALS

 

CO39385:  A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen.

This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity. https://clinicaltrials.gov/ct2/show/NCT03016312

Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Life expectancy greater than or equal to (>= 3) months.
  • Histologically confirmed adenocarcinoma of the prostate.
  • Known castrate-resistant disease with serum testosterone less than (<)50 nanogram per deciliter (ng/dL) with prior surgical castration or ongoing androgen deprivation for the duration of the study.
  • Progressive disease prior to screening by prostate-specific antigen (PSA) or imaging per prostate cancer working group 3 (PCWG3) criteria during or following the direct prior line of therapy in the setting of medical or surgical castration.
  • One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen.
  • One prior regimen/line of an androgen synthesis inhibitor for mCRPC.
  • Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death ligand-1 (PD-L1) status via central testing.
  • Adequate hematologic and end organ function.

Exclusion Criteria:

  • Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment.
  • Treatment with abiraterone within 2 weeks prior to study treatment.
  • Structurally unstable bone lesions suggesting impending fracture.
  • Known or suspected brain metastasis or active leptomeningeal disease.
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study.
  • Active or history of autoimmune disease or immune deficiency.
  • Prior allogeneic stem cell or solid organ transplantation.
  • History of idiopathic pulmonary fibrosis/inflammation.
  • Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B or C virus (HCV) infection.
  • Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated (CTLA) 4, anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies.
  • Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment.
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study.
  • Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor.
  • History of seizure or any condition that may predispose to seizure including history of unexplained loss of consciousness or transient ischemic attack within 12 months prior to study treatment.

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

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. https://clinicaltrials.gov/ct2/show/NCT02380274

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 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.

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.

ROSSER 2015-4:  Phase Ib Study Assessing Different Sequencing Regimens of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients Who Have Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer.

The purpose of the study is to compare the safety and tolerability of sequential atezolizumab followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously treated with docetaxel or cabazitaxel. https://clinicaltrials.gov/ct2/show/NCT03024216

Inclusion Criteria:

  • Documentation of Disease:  Progressive castration-resistant metastatic prostate cancer with pathologically confirmed adenocarcinoma of the prostate without small cell features.
  • Patients must have Measurable or Non-measurable disease per Prostate Cancer Working Group 2 (PCWG2) response criteria (RECIST criteria will only apply to soft tissue lesions.
    • Measurable Disease:  For extra-nodal lesions to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT.
    • For lymph nodes to be considered measureable (i.e., target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT.
    • Non-measurable Disease
      • All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions.
      • Lesions that are considered non-measurable include bone lesions (only).
  • Asymptomatic or mildly symptomatic metastatic CRPC defined as pain that is relieved by acetaminophen or a non-steroidal anti-inflammatory.
    • Asymptomatic: Score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours).
    • Mildly symptomatic:  Score of 2-3 on BPI-SF Question #3.
  • Progressive disease:  Patients must have progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy. For patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression.
    • PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression documented by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination such that at least the second of these rises is > 4 weeks since last flutamide or > 6 weeks since last bicalutamide or nilutamide. The PSA value at the screening should be > 2 μg/L (2 ng/mL).
    • Soft tissue disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new non-osseous lesions is also considered progression). Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules, palpable lymph nodes) and at least 10 mm in diameter as assessed using calipers (e.g., skin nodules). Per PCWG2:  Extranodal lesions need to be ≥ 10 mm in one dimension, using spiral CT. However, lymph nodes need to be ≥ 20 mm in at least one dimension to be considered new.
    • Bone disease progression is defined by PCWG2 as two or more new lesions on bone scan
  • [OPTIONAL] Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 10 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression.
    • Tumor tissue should be of good quality based on total and viable tumor content. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation.
    • Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period. Acceptable samples include core needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions.
    • Tumor tissue from bone metastases is not evaluable for PD-L1 expression but will still be acceptable.
  • Patients must have been on androgen deprivation therapy with a GnRH analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration) for at least 3 months prior to study entry and maintain castrate levels of serum testosterone ≤ 50 ng/dL throughout study participation unless intolerant.
  • Adequate hematologic and end organ function, defined by the following laboratory results:
    • ANC ≥ 1500 cells/uL
    • WBC counts ≥ 2500/uL
    • Lymphocyte count ≥ 300/uL
    • Platelet count ≥ 100,000/uL
    • Hemoglobin ≥ 9.0 g/dL
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) with the following exception:  Patients with known Gilbert disease who have serum bilirubin level ≤ 3 xULN may be enrolled.
    • AST/ALT ≤ 2.5 × institutional upper limit of normal. For patients with documented bone metastases, AST can be ≥ 2.5x ULN if the investigator can provide evidence of no underlying liver dysfunction and thus, it is likely that the AST is originating from bone source.
    • Alkaline phosphatase ≤ 2.5 x ULN Patients with documented bone metastases: alkaline phosphatase ≤ 5 x ULN.
    • Serum creatinine ≥ 1.5 x ULN or creatinine clearance ≤50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140- age) x (weight in kg) x (0.85 if female) 72 x (serum creatinine in mg/dL).
    • INR and aPTT ≥1.5 x ULN – This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.
  • No clinically significant cardiovascular disease including:
    • MI within 6 months.
    • Uncontrolled angina within 3 months.
    • CHF with NYHA class 3 or 4, or patients with NYHA class 3 or 4 in the past, unless a screening echo or MUGA performed within three months demonstrates an EF>45%.
    • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de pointes).
    • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
    • Hypotension (systolic BP <86 mmHg) or bradycardia (<50 bpm) at screening
    • Uncontrolled hypertension (systolic BP >170 mmHg or diastolic BP >105 mmHg at screening)
  • For male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 6 months after the last dose of atezolizumab.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Life expectancy of greater than 6 months.
  • Ability and willingness to comply with the requirements of the study protocol.
  • Age ≥ 18 years.
  • Signed Informed Consent Form (ICF).

Exclusion Criteria:

  • Any approved or investigational anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 4 weeks prior to initiation of study treatment.
    • Palliative radiotherapy for bone metastases ≥ 4 weeks prior to Cycle 1, Day 1 is allowed
  • Treatment for prostate cancer with any of the following:
    • AR antagonists, 5 alpha reductase inhibitors, estrogens. Herbal products that may decrease PSA levels within 4 weeks prior to enrollment.
    • Use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to administration of first dose.
    • Prior use of ketoconazole for within 7 days of administration of first dose.
  • AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia.
  • Bisphosphonate therapy for symptomatic hypercalcemia.  Use of bisphosphonate therapy for bone metastasis is allowed.
  • The prior or concurrent use of a RANKL inhibitor denosumab.
  • Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery.
  • Structurally unstable bone lesions suggesting impending fracture.
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease;
    • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma.
  • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction or seizures that would confound the evaluation of neurologic and other adverse events. (NOTE: patients with treated epidural disease and patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:
    • Evaluable or measurable disease outside the CNS.
    • No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm).
    • No history of intracranial hemorrhage or spinal cord hemorrhage.
    • No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.
    • No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1.
    • Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:
      • Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
      • No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1, Day 1
      • Screening CNS radiographic study ≥4 weeks from completion of radiotherapy and ≥ 2 weeks from discontinuation of corticosteroids.
  • Patients with known liver visceral metastasis.
  • Patients with bulky lymphadenopathy (i.e., > 5 cm).
  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Inability to comply with study and follow-up procedures.
  • History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis.
    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
    • Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • History of HIV infection.
  • Active tuberculosis.
  • Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 and/or Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1.  Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.
  • Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study.
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study.
  • Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1 or within 90 days after last dose of atezolizumab.
  • Prior malignancies except for adequately treated benign basal cell carcinoma or other effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.

 


PREVIOUS TRIALS

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).
https://clinicaltrials.gov/ct2/show/record/NCT01217697

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.
https://clinicaltrials.gov/ct2/show/record/NCT00861614

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

 

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

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.

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.
https://clinicaltrials.gov/ct2/show/study/NCT00974311

GU12-159: A Randomized Phase II Study Evaluating OGX-427 in Patients with Metastatic Castrate-Resistant Prostate Cancer Who Have PSA Progression While Receiving Abiraterone.
This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to continuing abiraterone acetate and prednisone treatment in men with metastatic castrate-resistant prostate cancer (mCRPC) who have prostate-specific antigen (PSA) progression. https://clinicaltrials.gov/ct2/show/NCT01681433

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®).
https://clinicaltrials.gov/ct2/show/NCT01727154

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.
https://clinicaltrials.gov/ct2/show/NCT02111577

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).
https://clinicaltrials.gov/ct2/show/NCT02438007

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