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Active Trials

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.

Inclusion Criteria:

  • Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL).
  • Evidence of bone metastasis related to prostate cancer on bone scans.
  • Documented pain from bone metastases that requires opioid narcotic intervention.
  • Adopted a narcotic regimen that consists of one sustained release opioid agent taken daily for chronic pain and one immediate release opioid agent for breakthrough pain.
  • Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of investigator assessed prostate cancer progression on each agent independently.
  • Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.
  • Recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable.
  • Adequate organ and marrow function.
  • A left-ventricular ejection fraction (LVEF) of >/= 50% assessed by echocardiogram or MUGA (multigated acquisition scan).
  • Capable of understanding and complying with the protocol requirements (including having the ability to access an interactive voice recognition system and self-report pain and narcotic use) and signed the informed consent form.
  • Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study treatment.

Exclusion Criteria:

  • Prior treatment with cabozantinib or mitoxantrone.
  • Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks.
  • Radiation therapy in the last 4 weeks (includes radiation targeting bone metastases), radionuclide treatment in the last 6 weeks, or radiation therapy to the thoracic cavity (unless radiation targets bone metastases) in the past 3 months.
  • Treatment with serotonergic psychiatric medication(s) in the last 2 weeks (5 weeks for fluoxetine).
  • Evidence of metastasis to the liver, known brain metastases or uncontrolled epidural disease.
  • Requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or FXa (coagulation factor X) inhibitors, or antiplatelet agents (eg, clopidogrel). Low dose aspirin (≤ 81 mg/day), low-dose warfarin (≤ 1 mg/day), and prophylactic low molecular weight heparin are permitted.
  • Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.
  • Clinically significant hematemesis or hemoptysis of > 0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months.
  • Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.
  • Corrected QT interval (QTc) > 500 ms in the last 4 weeks.
  • Unable to swallow capsules or tablets or tolerate infusions.
  • Previously-identified allergy or hypersensitivity to components of the study treatment formulations investigator or designee.
  • History of another malignancy (except non-melanoma skin cancer) in the past 2 years.

http://clinicaltrials.gov/ct2/show/NCT01522443?term=xl184&rank=13

 

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.

Inclusion Criteria:

  • Age at least 18 years at the time of signing the informed consent form. For patients in Taiwan the minimum age is 20 years.
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate.
  • Evidence of bone metastatic disease on radiographic examination, whether from bone scan (bone lesions) or other imaging modality.
  • Castrate levels of serum testosterone (≤50 ng/dL or 1.7 nmol/L).
  • Evidence of progressive disease after castration levels of testosterone have been achieved.
  • Karnofsky score ≥70%.
  • Meet screening laboratory values as specified in thr protocol.
  • If sexually active with partner of childbearing potential, patient will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug. The adequate contraceptive method should be continued for 14 days after the patient stops taking study drug.
  • No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
  • Able to swallow and retain oral medication.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study.
  • Able (or patient's legal guardian, if applicable) to sign and date the written informed consent after being informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information.

Exclusion Criteria:

  • Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years.
  • Previous anticancer therapy using radiation, biologics or vaccines, including sipuleucel-T (Provenge), abiraterone or MDV3100 within 4 weeks prior to the start of study treatment. If radiation therapy is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks after the radiation therapy.
  • Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide eg, Casodex®)
  • Concurrent use of other anticancer agents or treatments, with the following exceptions:
  • Ongoing treatment with luteinizing hormone-releasing hormone agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.
  • Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
  • Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy.
  • Ongoing treatment with warfarin. Treatment with other anticoagulants is allowed but should be discussed with medical monitor before inclusion.
  • Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.
  • Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone is not allowed within 1 year prior to the start of study treatment.
  • Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.
  • Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.
  • Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs less than 4 weeks prior to the start of study treatment.
  • Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or limb claudication at rest, within 6 months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.
  • History of pancreatitis.
  • Known brain or epidural metastases.
  • Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
  • Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients who have recovered from hepatitis will be allowed to enter the study).
  • Patients with active tuberculosis (TB), or with known, untreated latent TB. (Country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and the patient should intend to complete the entire course of that therapy.)
  • Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
  • Any patient who in the opinion of the investigator should not participate

http://clinicaltrials.gov/ct2/show/NCT01234311?term=10TASQ10&rank=1

 

OGX-011-11: A Randomized Phase III Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custersin (OGX-011) in Men with Metastatic Castrate-Resistant Prostate Cancer

This Phase III 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. Patients will be randomly assigned with equal probability to the two arms.

Inclusion Criteria:

  • Age > 18 years on the date of consent
  • Diagnosis of adenocarcinoma of the prostate
  • Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan
  • Systemic chemotherapy indicated due to progression while on or after androgen ablative therapy
  • Karnofsky score >70%

Exclusion Criteria:

  • Received any other cytotoxic chemotherapy as treatment
  • Participated in a prior clinical study evaluating OGX-011
  • History of or current documented brain metastasis or carcinomatous meningitis
  • Current symptomatic cord compression requiring surgery or radiation therapy
  • Active second malignancy (except non-melanomatous skin or superficial bladder cancer)
  • Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization

http://clinicaltrials.gov/ct2/show/NCT01188187?term=ogx011-11&rank=1

 

CA184-043: A Radomized, Double-blind, Phase III Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects with Castration Resistance Prostate Cancer that have Received Prior Treatment with Docetaxel

The study is to determine if advanced prostate cancer patient s that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone.

Inclusion Criteria:

  • Advanced prostate cancer
  • At least 1 bone metastasis
  • Testosterone < 50 ng/dl
  • Prior treatment with docetaxel

Exclusion Criteria:

  • Brain metastasis
  • Autoimmune disease
  • Known HIV, Hep B, or Hep C infection
  • More than 2 prior systemic anticancer regimens for prostate cancer
  • Prior treatment on BMS CA180-227 for prostate cancer

http://clinicaltrials.gov/ct2/show/NCT00861614?term=CA184-043&rank=1

 

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 study is to determine if patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo.

Inclusion Criteria:

  • Metastatic prostate cancer
  • Asymptomatic or minimally symptomatic
  • Progression during hormonal therapy
  • ECOG Performance Status 0-1

Exclusion Criteria:

  • Liver, lung or brain metastases
  • Prior immunotherapy or chemotherapy for metastatic prostate cancer
  • Autoimmune disease
  • HIV, Hepatitis B, or Hepatitis C infection

http://clinicaltrials.gov/ct2/show/NCT01057810?term=CA184-095&rank=1

 

P10-3 PROCEED: A Registry of Sipuleucel-T Therapy in Men with Advanced Prostate Cancer

Inclusion Criteria:

  • Subjects must be at least 18 years of age
  • Subjects with advanced prostate cancer who will receive sipuleucel-T
  • Subjects must understand and sign an informed consent form

Exclusion Criteria:

  • None

http://clinicaltrials.gov/ct2/show/NCT01306890?term=p10-3&rank=1