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

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.

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

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

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