Clinical Trials


Clinical trials, also called clinical studies, test new methods to treat, diagnose and prevent cancer. Only treatments that provide promising results in laboratory tests advance to clinical trials.

 

CLINICAL TRIALS

 

PHASE III TRIALS: Phase III clinical trials build upon evidence of effectiveness in previous Phase I & II trials in small samples, and expand to a larger sample in an attempt to confirm the experimental treatment's efficacy. This also applies to investigation of an existing treatment (or treatment combination) not previously examined in a particular category of disease. Treatments investigated in Phase III trials have stronger evidence of effectiveness than in previous phases.

Phase II TRIALS: Build upon evidence of safety from previous Phase I trials that indicate the relative safety and appropriate dosing of a new agent.  Once the Phase I trial demonstrates the appropriate dosage, the Phase II trial can commence to study the new agent in a single type of cancer to determine the response rate of the new agent.  So the advantage to the patient for a Phase II trial is that 100% of the men involved in the trial get the new agent.  No placebos are involved.  The disadvantage is that the effectiveness of the new agent is still being tested so it is often impossible to know what the response rate will be for any specific patient contemplating embarking on a Phase II trial.

Phase I TRIALS: Are performed primarily to determine the safe dosage of a brand new agent that has never been administered to humans before. Phase I trials start at a small dose and with successive patients who are accrued to the trial, the dosage is slowly escalated.  The trial ends when men start encountering unacceptable toxicity. Phase I trials are only for men who are very desperate or for the rare situation when clear cut responses have been reported with the men previously treated at lower doses with the same agent.  


PHASE III TRIALS


ARAMIS (BAY1841788 | ODM-201) 

A new oral medication called ARAMIS is being evaluated in men who have rising PSA levels on Lupron and whose bone scans remain clear.  For more information, visit: https://clinicaltrials.gov/show/NCT02200614

ARAMIS is similar to Xtandi but may have some advantages because ARAMIS is less likely to affect brain function which could reduce the likelihood of seizures and side effects such as fatigue which are potential side effects from Xtandi.  Two out of every 3 men in this study will be randomly assigned to receive investigational medication. 

The purpose of the study is to determine the safety and efficacy of ARAMIS in delaying prostate cancer from spreading outside of the prostate. 

To be eligible to participate in the trial men must: 

  • Have a PSA rising quickly enough to double in less than 10 months
  • No previous treatment with Xtandi or Zytiga
  • No prior chemotherapy or immunotherapy for prostate cancer.
  • Overall reasonably good health without serious heart problems.

If you are currently receiving hormone therapy, your treatment will continue and in addition you will receive either the investigational medication or placebo. Two out of every 3 patients will receive investigational medication and the assignment to the medication will be random. 

The purpose of the ARAMIS trial is to determine the safety and effectiveness of ARAMIS to delay prostate cancer from spreading. 

Talk with your doctor to find out if joining a clinical trial is right for you.

To learn more about the ARAMIS trial and to find out if you may be eligible to participate in the study, please visit:  http://www.bayerpharma.com/en/research-and-development/clinical-trials/trial-finder/index.php (Trial Number: 17712) or https://clinicaltrials.gov/ct2/show/NCT02200614?term=ARAMIS&rank=2  (Study Identifier: NCT02200614) or contact Bayer Oncology Clinical Trial Navigation Service 844-229-3710 (toll free) www.oncologytrials.bayer.com


 

XTANDI COMPARED TO OLDER PILLS SUCH AS CASODEX AND FLUTAMIDE

Enzalutamide (Xtandi) in First Line Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer. For more information, visit: https://clinicaltrials.gov/show/NCT02446405

This Phase III trial is testing the premise that earlier use of a more potent agent (Xtandi) will translate into improved survival.  Presently, for insurance reasons, access to Xtandi prior to the onset of hormone resistance is limited. Many experts believe, however, that early use of the most effective agent translates into improved survival.  This trial can benefit patients who have no potential access to the early use of Xtandi as it gives the participants a 50% chance they will receive the Xtandi free of charge.  

Experimental agent: Enzalutamide (Xtandi) may reduce tumor cell growth by blocking androgen receptors.
Purpose: Compare overall survival time between Enzalutamide and other anti-androgens.
Arm A: Enzalutamide + LHRH analogue (e.g. Lupron)
Arm B: Non-steroidal anti-androgen (e.g. Nilutamide, bicalutamide flutamide) + LHRH Analogue
Notable eligibility criteria:
- Metastatic disease
- No prior chemotherapy - exception: up to 2 cycles of Docetaxel for metastatic disease
- No history of seizure or conditions that predispose to seizure
- No history of Transient Isquemic Attacks

 

XTANDI WITH ZYTIGA

Enzalutamide (Xtandi) With or Without Abiraterone (Zytiga) and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer. For more information, visit: https://clinicaltrials.gov/show/NCT01949337

Xtandi and Zytiga block testosterone activity within the cancer cell using distinctly different biochemical pathways.  As such, both agents in combination are likely to be more effective than either agent by itself.  However, relatively few insurance companies will pay for the use of both of these agents at the same time.  Half the men in this study will receive a combination of both agents with the cost being borne by the company sponsoring the trial. 

Experimental agent: Enzalutamide (Xtandi) may reduce tumor cell growth by blocking androgen receptors.
Abiraterone (Zytiga) may suppress testosterone production by inhibiting activity of the CYP17 enzyme.
Purpose: Evaluate overall survival time under Enzalutamide when combined with Abiraterone.
Arm A: Enzalutamide
Arm B: Enzalutamide + Abiraterone
Notable eligibility criteria:
- Castrate-resistant metastatic disease
- No prior Abiraterone, Enzalutamide, or any chemotherapy
- No history of seizure or related conditions
- No history of TIA within 12 months

 

DENDRITIC CELL VACCINE

Phase III Study of DCVAC Added to Standard Chemotherapy for Men with Metastatic Castration Resistant Prostate Cancer (VIABLE). For more information, visit: https://clinicaltrials.gov/show/NCT02111577

Immune therapy is becoming more mainstream in prostate cancer, lung cancer and melanoma.  Generally the side effects are quite minimal compared to other types of therapy.  This trial adds immune therapy to standard Taxotere chemotherapy to determine if the immune treatment improves response rates and survival.  Since this form of immune therapy is not yet FDA approved this trial is the only way for patients to access the drug.  

Experimental agent: Dendritic cell vaccine (DCVAC/PCa) may destroy tumor cells by stimulating a cytotoxic T-lymphocyte (CTL) response against PSA-expressing cancer cells.
Purpose: Evaluate overall survival time under dendritic cell vaccine when combined with Docetaxel.
Arm A: Dendritic cells vaccine + Docetaxel (Taxotere)
Arm B: Placebo + Docetaxel
Notable eligibility criteria:
- Castrate-resistant metastatic disease
- No prior chemotherapy
- No prior immunotherapy within 6 months

 

ARN-509

A Study of ARN-509 in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN). For more information, visit: https://clinicaltrials.gov/show/NCT01946204

ARN-509 is a pill with similar function to Xtandi that is being studied in men with hormone resistance who have yet to develop any metastases.  Xtandi is only approved for men with metastases so insurance coverage is often denied. The advantage for patients in this trial is the earlier exposure to a more potent agent at a time before the disease has progressed to overt metastases. 

Experimental agent: ARN-509, an androgen receptor antagonist, may inhibit tumor cell growth by inhibiting genes that regulate cancer cell proliferation.
Purpose: Assess the effectiveness (survival time without metastases) of ARN-509.
Arm A: ARN-509
Arm B: Placebo
- Castrate-resistant disease WITHOUT metastases
- No prior Abiraterone or Enzalutamide
- No prior CYP17 inhibitors
- No prior chemotherapy

 

ARN-509

An Efficacy and Safety Study of JNJ56021927 in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC). For more information, visit: https://clinicaltrials.gov/show/NCT02257736

This study compares Zytiga alone with Zytiga plus ARN-509. Zytiga and ARN-509 block testosterone activity within the cancer cell using distinctly different biochemical pathways.  As such, both agents in combination are likely to be more effective than either agent by itself.  However, patients outside of this trial have no possibly opportunity of being treated with ARN-509 and Zytiga simultaneously because RN-509 has not yet been approved by the FDA. Half the men in this study will receive a combination of both agents with the cost being borne by the company sponsoring the trial

Experimental agent: JNJ56021927 (ARN-509), an androgen receptor antagonist, may inhibit tumor cell growth by inhibiting genes that regulate cancer cell proliferation.
Purpose: Assess the effectiveness (survival time without disease progression on scans) of JNJ56021927 when combined with Abiraterone.
Arm A: JNJ56021927 + Abiraterone (Zytiga)
Arm B: Placebo + Abiraterone
Notable eligibility criteria:
- Castrate-resistant metastatic disease
- No prior chemotherapy (except adjuvant/neoadjuvant use)
- No pain requiring opioids/narcotics

 

ORTERONEL (TAK-700)

Phase III Lupron+TAK-700 vs. Lupron+Bicalutamide for Metastatic, Hormone-Sensitive Prostate Cancer (SWOG 1216)
For more information, visit: https://clinicaltrials.gov/show/NCT01809691

Bicalutamide (Casodex) is generally the standard first step when Lupron stops working.  However, Bicalutamide is a relatively weak agent. TAK-700 is more potent than Bicalutamide and is therefore likely to be more advantageous.  TAK-700 is not yet approved by the FDA and is only available via a clinical trial such as this. 

Experimental agent: Orteronel (TAK-700) may suppress androgen-dependent tumor cell growth by inhibiting the 17,20 lyase steroid in the testes and adrenal glands.
Purpose: Compare overall survival time between TAK-700 (experimental) and Bicalutamide (established).
Arm A: ADT (equivalent of Lupron) + TAK-700
Arm B: ADT + Bicalutamide (Casodex)
- Metastatic disease
- No prior chemotherapy (neoadjuvant/adjuvant use allowed if > 2 years prior)
- No prior androgen deprivation therapy within 6 months (adjuvant/neoadjuvant use OK if total treatment < 36 months)
- No prior Ketoconazole, Aminoglutethimide, Abiraterone, or Enzalutamide

 

XTANDI

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)
For more information, visit: https://clinicaltrials.gov/show/NCT02003924 | Click here for a patient brochure of this trial. 

Xtandi is FDA approved for men with hormone resistance who have already developed metastases.  However, insurance coverage is often denied for men with hormone resistance who are yet to develop metastases.  The advantage for patients in this trial is the earlier exposure to a potent agent like Xtandi at a time before the disease has progressed to overt metastases may be advantageous.

Experimental agent: Enzalutamide (Xtandi) may reduce tumor cell growth by blocking androgen receptors.
Purpose: Assess the effectiveness (survival time without metastatic progression) of Enzalutamide in nonmetastatic disease.
Arm A: Enzalutamide
Arm B: Placebo
- Castrate-resistant disease WITHOUT metastases
- PSA doubling time ≤ 10 months
- No prior hormonal therapy except for LHRH therapies (e.g. Lupron, Eligard)
- No prior chemotherapy


HORMONE SENSITIVE, LOCALIZED NON METASTATIC DISEASE


 

PROSTATAK

Phase III Study of ProstAtak™ Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03)
Immune therapy it believed to have greater anticancer activity when used to treat earlier, low-volume disease.  In this study men with newly-diagnosed cancer that is relatively high risk can undergo radiation with our without immunotherapy.  The hope is that the men who receive immunotherapy can benefit with improved cure rates. For more information, visit: https://clinicaltrials.gov/show/NCT01436968

Experimental agent: ProstAtak (AdV-tk) may stimulate an antitumor cytotoxic T lymphocyte (CTL) response by working in conjunction with Valacyclovir to kill tumor cells overexpressing the HSV-tk gene.
Purpose: Assess the effectiveness (survival time without disease recurrence) of combining ProsAtak, Valacyclovir, and radiation therapy with optional androgen deprivation therapy.
Enrollment: 711
Arm A: ProstAtak (AdV-tk) + Valacyclovir + radiation therapy + (optional) androgen deprivation therapy
Arm B: Placebo + Valacyclovir + radiation therapy + (optional) ADT
Notable eligibility criteria:
- Intermediate Risk disease (PSA 10-20 ng/ml, Gleason score 7, T2b-T2c)
- No more than 1 High Risk feature (PSA>20 ng/ml, Gleason score 8-10, or T3a), no metastatic disease
- No prior treatment except TURP or ADT (maximum 6 months)

 

XTANDI

LHRH Analogue Therapy With Enzalutamide (Xtandi) or Bicalutamide (Casodex) in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer.  For more information, visit: https://clinicaltrials.gov/show/NCT02058706

Until the relatively recent FDA approval of Xtandi for hormone resistant disease Casodex and Lupron was the only alternative.  This trial is designed to test the premise that initiating Xtandi immediately, rather than waiting for resistance to Casodex and Lupron develop, is advantageous for patients.  In this trial half the men will receive immediate Xtandi and the other half will receive the traditional combination of Casodex and Lupron. 

Agent: Enzalutamide (Xtandi) may reduce tumor cell growth by blocking androgen receptors.
Purpose: Compare the effectiveness (PSA remission) between Enzalutamide (experimental) and Bicalutamide (known) in hormone sensitive prostate cancer.
Enrollment: 92
Arm A: Enzalutamide + LHRH analogue (Lupron, etc.)
Arm B: Bicalutamide (Casodex) + LHRH analogue
Notable eligibility criteria:
- Metastatic disease
- PSA ≥ 4 ng/ml within 28 days if no prior hormone therapy
- No prior neoadjuvant/adjuvant hormone therapy within 6 months
- No prior chemotherapy or androgen synthesis/receptor blockers (Abiraterone, Enzalutamide, TAK-700, ARN-509, etc.)
- No history of seizure or conditions that predispose to seizure. 

 

PROVENGE WITH YERVOY

A Randomized Phase II Trial of Combining Sipuleucel-T With Immediate vs. Delayed CTLA-4 Blockade for Prostate Cancer
Immune therapy has been the hot topic of 2015 with new and powerful agents showing dramatic activity in both lung cancer and melanoma.  One agent, Yervoy, that works by “taking the brakes off the immune system” has affected notable responses in very difficult cases of melanoma.  Yervoy has also been tested in very advanced prostate cancer and shown to have notable activity.  Combining Yervoy with Provenge, another immunotherapy that is already FDA approved for prostate cancer is a very compelling concept. Despite the fact that Yervoy can be associated with potentially severe side effects, this Phase II trial is potentially one of the most attractive trials for patient with hormone resistant disease. For more information, visit: https://clinicaltrials.gov/show/NCT01804465

Experimental agent: Sipuleucel-T (Provenge) may stimulate an antitumor T-cell response against PAP-expressing tumor cells. Ipilimumab (Yervoy) may stimulate a cytotoxic T-lymphycite (CTL)-mediated immune response against cancer cells by inhibiting the CTLA4-mediated downregulation of T-cell activation.
Purpose: Assess the impact (on immune response) of the timing of Ipilimumab following Sipuleucel-T.
Arm A: Sipuleucel-T + immediate Ipilimumab
Arm B: Sipuleucel-T + 3-week delayed Ipilimumab
Notable eligibility criteria:
- Castrate-resistant metastatic disease
- No prior chemotherapy except neoadjuvant use
- No prior Sipuleucel-T or experimental immunotherapy
- No cancer pain requiring narcotics
- No history of autoimmune disease

 

PROSTVAC

Prostvac (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance. For more information, visit: https://clinicaltrials.gov/show/NCT02326805

Agent: Prostvac-V/TRICOM is an immunotherapy vaccine that may encourage a cytotoxic T-cell immune response against PSA-expressing tumor cells.
Purpose: Evaluate response in PSA and immune indicators to Prostvac-V
Enrollment: 150
Arm A: Prostvac-V/TRICOM
Arm B: Placebo
Notable eligibility criteria:
- No prior treatment (including surgery, irradiation, local ablative, or androgen deprivation)
- No distant metastases
- No immunodeficiency or splenectomy

 

ADXS-PSA

ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Patients With Prostate Cancer - KEYNOTE-046
For more information, visit: https://clinicaltrials.gov/show/NCT02325557

Agent: ADXS-PSA (or ADXS31-142), an immunotherapy, may drive an immune response to PSA-expressing cells by targeting prostate-specific antigen (PSA) associated with prostate cancer.
Pembrolizumab (Keytruda) may activate T-cell-mediated immune responses against tumor cells by binding to and inhibiting the programmed cell death-1 (PD-1) protein.
Purpose: Assess the safety and effectiveness (survival without disease progression) of immunotherapy ADXS-PSA.
Enrollment: 51
Part A (Phase I): ADXS-PSA
Part B (Phase I-II): ADXS-PSA + Pembrolizumab
Notable eligibility criteria:
- Castrate-resistant metastatic disease
- No more than 3 prior treatment (chemotherapy, hormonal, or immunotherapy) in metastatic setting
- No more than 1 chemotherapy in metastatic setting
- No active autoimmune disease requiring systemic treatment within the past 2 years


OTHER STUDIES


Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) (TRUMPET)

The purpose of this registry is to describe patterns of care in CRPC patients, as well as health-related quality of life (HRQoL) outcomes associated with CRPC and its management. Unlike clinical trial studies, registries are not designed to test potential new medical treatments. They simply collect information about treatments that are already being used, allowing doctors to see how well they work in a “real-world” setting of care.  

This observation study will look at how doctors’ decisions and the treatments they prescribe affect the day-to-day lives of the men who receive them. We hope this information may help improve the care of men with advanced prostate cancer in the future. The TRUMPET Registry is for men whose prostate cancer progressed (i.e. it has grown or spread) despite use of hormonal treatments to lower their PSA.  Known as castration-resistant prostate cancer, this disease progression may require different treatment options, which can be discussed with the treating physician. Upon enrolling in TRUMPET, information will be confidentially collected at routine medical visits and through health surveys.

Notable eligibility criteria:

- Confirmed diagnosis of CRPC

- Patients may be enrolled within 90 days from the time of decision to treat or within 90      days of treatment initiation.

- Initiating the first or second line treatment for CRPC

To inquire about registering at participating study centers, please contact Astellas Scientific & Medical Affairs by calling (800) 888-7704, extension 5473, or emailing Astellas.registration@astellas.com. For more information, visit: https://clinicaltrials.gov/show/NCT02380274