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Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01875250
Recruitment Status : Active, not recruiting
First Posted : June 11, 2013
Last Update Posted : January 25, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate cancer. It is given to help kill cancer cells and limit cancer cell growth. A new possible way of treating prostate cancer is using a therapeutic cancer vaccine (immune stimulating therapy) that may help activate the immune system against the cancer. The immune stimulating vaccine will help white blood cells recognize and kill the cancer cells throughout the body. This vaccine therapy has been tested in hundreds of patients and is very well tolerated. Researchers want to see whether this vaccine, given with enzalutamide, is more effective at treating advanced prostate cancer than enzalutamide alone.


- To compare the safety and effectiveness of enzalutamide with and without vaccine therapy for advanced prostate cancer.

Key Eligibility:

  • Men at least 18 years of age who have advanced castration sensitive prostate cancer.
  • Patients must have testosterone within the normal range
  • No evidence of metastatic prostate cancer on CT or Bone scan
  • No history of autoimmune diseases
  • No previous immunotherpy within 3 years


  • Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be used to monitor the cancer before treatment.
  • Participants will be separated into two groups. One group will have enzalutamide and the study vaccine. The other group will have enzalutamide alone.
  • All participants will take enzalutamide once a day. They will take the drug for 3 months. This form of intermittent therapy is common in this population of patients.
  • The vaccine group of participants will receive the new study vaccine. They will have a single injection on the first day of the first study cycle. There will be regular booster injections afterward. There will be one injection during the third week of treatment, and one in the fifth week. The vaccine will then be given every 4 weeks until 21 weeks have passed.
  • Treatment will be monitored with frequent blood tests and imaging studies.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: PROSTVAC-F/TRICOM Biological: PROSTVAC-V/TRICOM Drug: Enzalutamide (Xtandi) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
Study Start Date : June 7, 2013
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Arm Intervention/treatment
Experimental: Arm A
Enzalutamide for 3 months
Drug: Enzalutamide (Xtandi)
An androgen receptor inhibitor.

Experimental: Arm B
Enzalutamide 3 months + PSA-TRICOM on weeks 1, 3, 5, 9,13,17 and 21
A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.

A recombinant vaccinia virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.

Drug: Enzalutamide (Xtandi)
An androgen receptor inhibitor.

Primary Outcome Measures :
  1. Tumor growth rate [ Time Frame: 3 years ]
    Decrease in tumor re-growth rate

Secondary Outcome Measures :
  1. Immune response [ Time Frame: 3 years ]
  2. Determine impact on PSA [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

A. Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, or Walter Reed National Military Medical Center prior to enrollment. If no pathologic specimen is available, patients may enroll with a pathologist s report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.

B. Biochemical progression defined as follows:

  • For patients following definitive radiation therapy: a rise in PSA of greater than or equal to 2 ng/mL above the nadir (per RTOG-ASTRO consensus criteria).
  • For patients following radical prostatectomy: rising PSA after surgical procedure. (Patients must have a PSA greater than or equal to 2ng/ml)

C. ECOG performance status of 0-1 (Karnofsky greater than or equal to 80%).

D. Patients must have a PSA doubling time of 12 months or less. E. Patients must have a rising PSA as confirmed by 3 values done at least 1 week apart and over no less than 1 month.

F. Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no toxicity greater than or equal to grade 2.

G. Negative CT scan/MRI and bone scan for metastatic prostate cancer.

H. Hematological eligibility parameters (within 16 days before starting therapy):

Granulocyte count greater than or equal to 1000/mm(3)

Platelet count greater than or equal to 100 000/mm(3)

Hgb greater than or equal to 10 g/dL

I. Biochemical eligibility parameters (within 16 days before starting therapy):

Hepatic function: bilirubin less than or equal to 1.5 mg/dL (OR in patients with Gilbert s syndrome, a total bilirubin less than or equal to 3.0), AST and ALT less than or equal to 2.5 times upper limit of normal.

J. No other active malignancies within the past 36 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnesses

K. Willing to travel to the NIH for follow-up visits.

L. 18 years of age or older.

M. Able to understand and sign informed consent.

N. Baseline testosterone greater than or equal to lower limit of normal.

O. PSA less than or equal to 20 ng/mL.

P. The effects of enzalutamide, PSA-TRICOM or the combination on the developing human fetus are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.


A. Immunocompromised status due to:

  • Human immunodeficiency virus (HIV) positivity.
  • Active autoimmune diseases such as Addison s disease, Hashimoto s thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave s disease. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
  • Other immunodeficiency diseases

B. Chronic administration (defined as daily or every other day for continued use greater than 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PSA-TRICOM. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.

C. Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient s ability to carry out the treatment program.

D. History of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack, or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).

E. Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (eg phytoestrogens and saw palmetto)

F. History of prior chemotherapy

G. History of prior immunotherapy within the last 3 years

H. Major surgery within 4 weeks prior to enrollment (Day 1 visit).

I. History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or poxviral vaccines (e.g., vaccinia vaccine)

J. Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin).

K. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis

L. Previous serious adverse reactions to smallpox vaccination

M. Unable to avoid close contact or household contact with the following highrisk individuals for three weeks after the Day 1 vaccination: (a) children 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.

N. Receipt of an investigational agent within 30 days (or 60 days for an antibodybased therapy) before the first planned dose of study drugs.

O. Patients who test positive for HBV or HCV

P. Use of herbal products that may decrease PSA levels (e.g. saw palmetto)

Q. Any gastrointestinal disease that could hinder the absorption of enzalutamide

R. Uncontrolled hypertension (SBP>170/ DBP>105)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01875250

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Ravi A Madan, M.D. National Cancer Institute (NCI)

Additional Information:
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT01875250     History of Changes
Other Study ID Numbers: 130153
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: October 2, 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gene Transfer
Androgen Receptor Antagonist
Immune Response

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents