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Previous Trials

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

The study is 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.

Inclusion Criteria:

  • Progressive prostate cancer
  • Medical or surgical castration with testosterone less than 50 ng/dl
  • One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
  • ECOG performance status 0-2
  • Adequate bone marrow, hepatic, and renal function
  • Able to swallow the study drug and comply with study requirements
  • Informed consent

Exclusion Criteria:

  • Metastases in the brain or active epidural disease
  • Another malignancy within the previous 5 years
  • Clinically significant cardiovascular disease
  • GI disorder affecting absorption

http://www.clinicaltrials.gov/ct2/show/NCT00974311?term=crpc2&rank=1

 

212082PCR3001: An Open Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed after Taxane-based Chemotherapy

This study collects additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

Inclusion Criteria:

  • Confirmed prostate cancer
  • Prostate cancer progression after previous chemotherapy as assessed by the investigator
  • Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel)
  • Serum testosterone of less than 50ng/dL (less than 2.0 nM)
  • Eastern Cooperative Oncology Group (ECOG) performance status of <=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities)

Exclusion Criteria:

  • Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection)
  • Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests
  • Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)
  • History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
  • Known brain metastasis (ie, spread of cancer to the brain)

http://www.clinicaltrials.gov/ct2/results?term=212082PCR3001

 

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 III 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.

Major Inclusion Criteria:

  • Metastatic Castration-Resistant Prostate Cancer
  • Progression after one or two prior cytotoxic chemotherapies. At least one chemotherapy must have contained docetaxel
  • ECOG Performance Status less than/ equal to 2
  • Medical or surgical castration with testosterone less than 50 ng/dL
  • Adequate bone marrow, hepatic and renal function
  • Potassium greater than/ equal to 3.5 mmol/L
  • Able to swallow the study drug whole as a tablet
  • Informed Consent

Major Exclusion Criteria:

  • More than two prior cytotoxic chemotherapy regimens
  • Prior Ketoconazole for prostate cancer
  • Prior Abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
  • Uncontrolled hypertension
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease
  • Other malignancy
  • Known brain metastasis
  • GI disorder affecting absorption
  • Not willing to use contraception

http://www.clinicaltrials.gov/ct2/show/NCT00638690?term=COU-AA-301&rank=1

 

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 III study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer.

Inclusion Criteria:

  • Metastatic castration-resistant prostate cancer
  • Previous anti-androgen therapy and progression after withdrawal
  • ECOG performance status of either 0 or 1
  • Medical or surgical castration with testosterone less than 50 ng/dL
  • Able to provide written informed consent

Exclusion Criteria:

  • Prior cytotoxic chemotherapy or biologic therapy for CRPC
  • Prior ketoconazole for prostate cancer
  • Known brain metastasis or visceral organ metastasis
  • Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1

http://www.clinicaltrials.gov/ct2/show/NCT00887198?term=COU-AA-302&rank=1

 

ABT627: A Phase II/III Extension study to Evaluate the Safety and Tolerability of Atrasentan

This phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

Inclusion Criteria:

  • prostate adenocarcinoma,
  • radical prostatectomy,
  • PSA between 0.4 and 5 ng/mL,
  • PSADT < 1 year

Exclusion Criteria:

  • previous hormonal therapy,
  • salvage therapy to the pelvis within 3 months prior to randomization

http://www.clinicaltrials.gov/ct2/show/NCT00038662?term=ABT627&rank=3

 

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 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.

Inclusion Criteria:

  • Must sign an Informed Consent Form (ICF)
  • Males ≥ 18 years of age
  • Able to adhere to the study visit schedule and requirements of the protocol
  • ECOG performance status of ≤ 2
  • Life expectancy of ≥ 12 weeks
  • Willingness to participate in Patient-Reported Outcomes assessments
  • Serum testosterone levels < 50 ng/dL
  • Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
  • Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum PSA level, Radiological Progression, or ≥2 new bone lesions
  • Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
  • Refrain from donating blood or semen as defined by protocol

Exclusion Criteria:

  • A history of clinically significant disease that places subject at an unacceptable risk for study entry
  • Prior Therapy with thalidomide, lenalidomide or pomalidomide
  • Prior chemotherapy for prostate cancer
  • Use of any other experimental drug or therapy within 28 days prior to randomization
  • Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
  • Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
  • Surgery within 28 days prior to randomization
  • Concurrent anti-androgen therapy
  • Abnormal serum chemistry or hematology laboratory values
  • Significant active cardiac disease within the previous 6 months:
  • Thrombotic or thromboembolic events within the past 6 months:
  • History of peripheral neuropathy of ≥grade 2
  • History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • Paraplegia
  • History of central nervous system (CNS) or brain metastases
  • History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin
  • Concurrent use of alternative cancer therapies

http://www.clinicaltrials.gov/ct2/show/NCT00988208?term=cc-5013-pc-002&rank=1

 

EN99-01: A Phase II Study to Determine the Effectiveness of Pecta-Sol in Prostate Cancer

 

TAX-327: A Multicenter Phase III Randomized Trial Comparing Docetaxel Administrated Either Weekly or Every Three Weeks in Combination with Prednisone Versus Mitoxantrone in Combination with Prednisone for Metastatic Hormone Refractory Prostate Cancer