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Protocol Details

A Randomized Phase II Trial Combining Vaccine Therapy with PROSTVAC /TRICOM and Flutamide, vs. Flutamide Alone in Men with Androgen Insensitive, Non Metastatic (D0.5) Prostate Cancer

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male
Min Age: 18
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women


Hormonal Therapy;
Combination Therapy;
Prostate Specific Antigen;

Recruitment Keyword(s)

Prostate Cancer


Prostate Cancer

Investigational Drug(s)


Investigational Device(s)



Drug: Sargramostim (GM-CSF, Leukine)
Drug: Flutamide (Eulexin)
Biological/Vaccine: PROSTVAC-F/ TRICOM
Biological/Vaccine: PROSTVAC-V/TRICOM

Supporting Site

National Cancer Institute


-Flutamide is an approved drug for prostate cancer that blocks the effects of testosterone on prostate cancer cells and may slow the progression of the disease.

-The vaccine in this study consists of a priming vaccine called PROSTVAC-V/TRICOM, made from vaccinia virus, and a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox virus. DNA is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce prostate specific antigen (PSA) a protein that is normally produced by the patient s tumor cells.

-GM-CSF, given along with the vaccine, is a chemical that boosts the immune system. It is used in this study to try to increase the usefulness of the vaccine by increasing the number of immune cells at the vaccination site.


-To determine if treatment with a prostate cancer vaccine plus flutamide is more effective than flutamide alone in delaying disease progression in patients with prostate cancer.


-Patients 18 years of age and older with androgen-insensitive prostate cancer that has not spread beyond the prostate gland.

-Patients with a rising PSA who have already been treated with anti-iandrogen therapy (either bicalutamide or nilutamide).


-There are two treatment groups in this study. Group A receives only flutamide; group B receive flutamide plus vaccine.

-Patients in both groups receive flutamide by mouth three times a day.

-Patients in group B receive PROSTVAC-V/TRICOM on day 1 and PROSTVAC-F/TRICOM on day 29 and again every 4 weeks. All vaccines are given as injections under the skin.

-Patients have blood tests for PSA levels every month and scans every 3 months until the disease worsens.

-After 3 months of therapy, patients receiving in group A (flutamide alone) may cross over to receive vaccine if they develop a rising PSA and scans show no sign of disease spread. Patients in group B (flutamide plus vaccine) stop flutamide and may continue vaccine therapy. At this point patients may continue to receive treatment until the disease progresses or PSA levels rise.

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A. Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at the: NIH Clinical Center prior to starting this study. 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. Must have non-metastatic androgen insensitive prostate cancer with a rising PSA with castrate levels of testosterone and no evidence of metastatic disease on CT scan or bone scan. A rising PSA is defined as two consecutively rising PSA levels, separated by at least 1 month apart, with the last measurement that is greater than 1ng/ml. Patients on nilutamide therapy must undergo nilutamide withdrawal for at least 4 weeks and still show evidence of a rising PSA. Following treatment with bicalutamide, patients must undergo withdrawal for at least 6 weeks and still show evidence of a rising PSA.

C. Life expectancy greater than or equal to 6 months.

D. ECOG performance status of 0-1.

E. No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy.

F. Hematological eligibility parameters:

-Granulocyte count greater than or equal to 1,500/mm(3).

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

-Hgb greater than or equal to 9 Gm/dL

-Lymphocyte count greater than or equal to 500/mm(3).

G. Biochemical eligibility parameters (within 16 days of starting therapy)

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

H. No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses.

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

J. 18 years of age or greater.

K. Able to understand and sign informed consent.

L. Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 4 months after the last vaccination therapy. Patients must be willing to remain on chemical castration therapy, unless they have had surgical castration.

M. Patients must have recovered from acute toxicities related to prior therapy or surgery.

N. Parameters for assessment of baseline renal function:

Serum creatinine less than or equal to 1.5 times the upper limit of normal OR creatinine clearance on a 24-h urine collection of greater than or equal to 60 mL/min.


A. Patients should have no evidence of being immunocompromised as listed below.

-Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects.

-Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. Nasal or inhaled steroid use is permitted.

-Patients who have undergone allogenic peripheral stem cell transplantation or solid organ transplantation requiring immunosuppression.

B. Patients who test positive for active Hepatitis B or Hepatitis C infection.

C. Patients should have no autoimmune diseases that have required treatment such as, Addison's disease, Hashimoto's thyroiditis, or systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, active Grave's disease.

D. History of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen.

E. Do not administer the recombinant vaccinia vaccine if the recipient, or for at least three weeks after vaccination, their close household contacts (close household contacts are those who share housing or have close physical contact) are: persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection.

F. Serious intercurrent medical illness (e.g., one that requires treatment) which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.

G. Patients with cardiac disease that have fatigue, palpitation, dyspnea or angina with ordinary physical activity (New York Heart Association class 2 or greater) are not eligible.

H. Patients with a history of congestive heart failure or who have objective evidence of congestive heart failure by physical exam or imaging are not eligible.

I. Patients with pulmonary disease that have fatigue or dyspnea with ordinary physical activity are not eligible.

J. Concurrent chemotherapy.

K. No known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis.

L. Patients with a serious hypersensitivity reaction to egg products are not eligible.

M. Prior splenectomy.

N. Patients who have received prior flutamide therapy in the last year. (Patients treated with flutamide in the neoadjuvant or adjuvant setting or those previously treated with flutamide who did not have a rising PSA on treatment would be allowed to enroll on the protocol.)

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Ravi A. Madan, M.D.
National Cancer Institute (NCI)

(301) 480-7168

Sheri A. McMahon, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N254
10 Center Drive
Bethesda, Maryland 20892
(240) 760-7968

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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