Are you a new patient?
Get started here
Prostate Snatcher Blog
Check it out

Clinical Trials

Our clinic’s primary goal is excellent patient care—not research. We limit our research involvement to clinical trials of promising new drugs that are unavailable from any other source. We do not get involved in research simply for the sake of doing research but in order to benefit our patients by having access to a greater number of treatment options.

Unfortunately, not all research drugs ultimately prove effective. Pursuing ineffective and unproven drugs, research or otherwise, can waste important time, time that could be better utilized by trying proven agents already on the market. It is a mistake to presume that a “new” agent available in a clinical trial will be beneficial. Patients need to be aware that at large clinical research centers doctors can be financially motivated to put patients on clinical trials.

For more information, please contact our study coordinator, Sabrina Yep. 310. 827.7707 or sabrina@prostateoncology.com


TOK-200-15 ARMOR3-SV: 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).

Inclusion Criteria:

  • Progressive metastatic (M1) disease on androgen deprivation therapy
  • Detectable AR-V7 from circulating tumors (CTCs)
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
  • Prior treatment with chemotherapy for CRPC

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


SP005 VIABLE: 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.

Inclusion Criteria:

  • Male 18 years and older
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis
  • Disease progression despite Androgen Deprivation Therapy
  • Maintenance of castrate conditions
  • Life expectancy of at least 6 months based on Investigator´s judgment.
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • At least 4 weeks after surgery or radiotherapy
  • A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy
  • Recovery from primary local surgical treatment, radiotherapy or orchiectomy

Exclusion Criteria:

  • Confirmed brain and/or leptomeningeal metastases
  • Current symptomatic cord compression requiring surgery or radiation therapy
  • Prior chemotherapy for prostate cancer
  • Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone)
  • Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within the previous 6 months
  • Systemic immunosuppressive therapy for any reason
  • Treatment with immunotherapy against PCa within the previous 6 months prior to randomization
  • Clinically significant cardiovascular disease
  • Active autoimmune disease requiring treatment
  • Uncontrolled co-morbidities
  • Participation in a clinical trial using experimental therapy within the last 4 weeks prior to randomization
  • Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6 months prior to randomization

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


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.

Inclusion Criteria:

    Subjects must meet ALL of the following criteria to be eligible for inclusion into the study:
  • Histological or cytological diagnosis of adenocarcinoma of the prostate
  • Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) scan and/or bone scan
  • Currently receiving abiraterone acetate and prednisone and meeting the following criteria:
    • Any PSA decline within 12 weeks from initiation of abiraterone acetate
    • Currently tolerating abiraterone acetate (1000 mg oral daily) and prednisone (10-20 mg oral daily)
    • PSA progression, defined as an increase in PSA which is ≥25% above the nadir and an absolute value of ≥2 ng/mL, which is confirmed by a second value ≥2 weeks later.
    • No evidence of symptomatic or radiographic progression that would require alternative therapy (e.g., needing radiation therapy for pain or significant progression of visceral metastases or >33% increase in daily opioid use within 2 weeks prior to randomization).
  • All patients who have not had a surgical orchiectomy must continue treatment with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist to maintain a castrate level of testosterone.
  • Patient must fulfill "Prior Therapy" criteria as follows:
    • Chemotherapy: no more than 1 prior chemotherapy regimen for castrate-resistant prostate cancer (CRPC) is permitted; a minimum of at least 28 days must have passed since the last dose of chemotherapy.
    • Hormone therapy: hormonal androgen ablation therapy prior to abiraterone is required.
    • Experimental therapy: prior non-cytotoxic experimental therapy is permitted provided a minimum of at least 14 days has passed since completing therapy. Prior treatment with enzalutamide (MDV3100) is allowed.
    • Radiation: prior external beam radiation is permitted provided a minimum of at least 14 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization
  • Must be willing to use effective contraception throughout study treatment and for 3 months after completion of study treatment if able to father a child.
  • Must be willing not to change (add or subtract) bone protecting therapy (bisphosphonates and/or denosumab) during the study unless changed for toxicity.
  • Written informed consent must be obtained prior to any protocol-specific procedures being performed.

Exclusion Criteria:
Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study:

  • Currently receiving abiraterone acetate in combination with any other anti-cancer agent (except prednisone)
  • Documented brain metastases, or carcinomatous meningitis, treated or untreated (Brain imaging for asymptomatic patients is not required.)
  • Cord compression requiring surgery or radiation therapy while on abiraterone treatment
  • Active second malignancy (including lymphoid malignancies such as chronic lymphocytic leukemia or low grade lymphoma) defined, in general, as requiring anticancer therapy or at high risk of recurrence during the study; not including adequately treated non melanomatous skin cancer or other solid tumors curatively treated with no evidence of disease in > 3 years
  • History of allergic reactions to therapeutic antisense oligonucleotides
  • Active autoimmune disease requiring treatment
  • Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment (i.e., either control or investigational arm), or prior exposure to OGX-427
  • Uncontrolled medical conditions such as myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy
  • Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.

https://clinicaltrials.gov/ct2/show/study/NCT01681433


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.

Inclusion Criteria:
Patient Inclusion:

  • 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 active course of anti-cancer treatment for M0 CRPC or for M1 CRPC (regardless of prior M0 CRPC treatment) such as anti-androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. Patients may be enrolled within 45 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.

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


P12-1 PREDICT: 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. Inclusion Criteria:

  • Written informed consent obtained prior to the initiation of study procedures.
  • Men ≥ 18 years of age.
  • Histologically documented prostatic adenocarcinoma.
  • History of Castration-Resistant Prostate Cancer.

Exclusion Criteria:

  • Known M1 disease.
  • Undergone imaging study for metastatic prostate cancer ≤ 3 months.
  • ECOG performance status ≥ 3.
  • Known malignant pleural effusions or ascites.
  • Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride).

https://clinicaltrials.gov/ct2/show/NCT01981109


P11-4 PRIME: 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®).

Inclusion Criteria:

  • Subjects must be at least 18 years of age
  • Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
  • Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
  • Subjects must understand and sign an informed consent form prior to their first leukapheresis

Exclusion Criteria:

  • None

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