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Protocol Details

Phase II Randomized, Placebo-Controlled Trial of PROSTVAC (PSA-TRICOM) in Patients with Clinically Localized Prostate Cancer Undergoing Active Surveillance

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: 99

Referral Letter Required


Population Exclusion(s)



Prostatic Neoplasms;
Prostate Adenocarcinoma;
Therapeutic Uses

Recruitment Keyword(s)



Prostatic Neoplasms

Investigational Drug(s)


Investigational Device(s)



Drug: Placebo

Supporting Site

National Cancer Institute


-Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.

-Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is PSA, due to its restricted expression on prostate cancer and normal prostatic epithelial cells.

-A neoadjuvant approach may be of potential benefit providing prolonged protection via the patient s immune system against future recurrence.

-PROSTVAC is a vaccine that induces strong immune responses, has shown promising evidence of activity in a randomized phase II study (8.5 month improvement in medianoverall survival) and is currently in phase III clinical testing.

-This vaccine has been tested in locally recurrent prostate cancer with substantial inflammatory infiltrates within the prostate seen following subcutaneous and intraprostatic injection.



--To determine the effect of PROSTVAC(R) on the change (from pre to post-intervention) in CD8+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.

--To determine the effect of PROSTVAC(R) on the change in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.


--Biopsy-proven adenocarcinoma of the prostate

--Screening serum PSA < 20 ng/mL. For men treated with 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride), PSA needs to be < 10 ng/mL.

--Karnofsky >=70%

--Men, >= 18 years of age

--No planned prostate biopsies during the intervention until after the post-intervention biopsy

--Ability to understand and the willingness to sign a written informed consent document.


This is a Phase II randomized, placebo-controlled, double-blind trial of PROSTVAC(R) in patients with clinically localized prostate cancer undergoing active surveillance. We plan to recruit men with a diagnosis of localized prostate cancer who are being monitored by active surveillance. Eligible participants will be randomized to receive PROSTVAC or placebo.

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-Biopsy-proven (consisting of greater than or equal to 10 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core, either random or targeted, in the most recent biopsy

-All prior biopsies must meet the following

-- less than or equal to 50% of the total number of random biopsy cores positive for cancer

--Gleason score less than or equal to (3+4)

-Clinical stage less than or equal to T2a by DRE

-Biopsies performed at outside institutions should have Gleason score confirmed at the study site to by a GU pathologist to ensure eligibility.

-Pre-intervention biopsy tissue (most proximal to enrollment) containing sufficient tumor tissue to cut 5-10 unstained slides confirmed to be available upon request.

- Screening serum PSA < 20 ng/mL. For men treated with 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride), PSA needs to be < 10 ng/mL.

-Hematological eligibility parameters:

--Neutrophil count greater than or equal to 1,200/mm^3 (greater than or equal to 1.2 k/microlitre)

--Stable platelet count greater than or equal to 75,000/mm^3 (greater than or equal to 75k/microlitre)

-Hepatic and renal function eligibility parameters:

--Bilirubin less than or equal to 1.5 mg/dL (or less than or equal to 3.0 mg/dL for patients with Gilbert s syndrome)

--ALT and AST less than or equal to 2.5 x ULN

--Serum creatinine less than or equal to 1.5 x ULN

-Karnofsky greater than or equal to 70%

-Must agree to use medically acceptable barrier and/or chemical method of contraception while on study and for at least one month following the last vaccine injection because the effects of PROSTVAC on the developing human fetus at the recommended therapeutic dose are unknown. Should a participant's partner become pregnant or suspect she is pregnant while the participant is participating in this study, the study physician should be informed immediately. In the event a participant s partner becomes pregnant, the study sponsor may request additional information regarding the course of the pregnancy and if the pregnancy is carried to term, the birth of the child (i.e., the outcome of the pregnancy).

-Ability to understand and the willingness to sign a written informed consent document.

-No planned prostate biopsies during the intervention until after the post-intervention biopsy.

- Men on stable doses of 5-alpha reductase inhibitors are eligible as long as there is no planned dose change while on study.


-Have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy.

-Patients who have prostate cancer with distant metastases.

-Have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years.

-Uncontrolled intermittent illnesses or medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. Such illnesses/conditions may include, but are not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

-Positive for HIV or active infections for hepatitis B, and /or hepatitis C, based on medical history.

-Prior solid organ or bone marrow transplant.

-Immunodeficiency or splenectomy.

-Chronic immunosuppressive therapy within 30 days of screening.

-Inflammatory eye disease requiring steroid treatment within 28 days of screening.

-Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of the first planned dose of PROSTVAC-V/F. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.

-History of or active autoimmune disease including but not limited to autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosis, Sjogren s syndrome, scleroderma, myasthenia gravis, Goodpasture s syndrome, rheumatoid arthritis, Addison s disease, Hashimoto s thyroiditis, or Graves disease. Persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.

-Known allergy to eggs, egg products.

-Prior or concurrent eczema or other eczemoid skin disorders or active skin condition (acute, chronic, or exfoliative) that disrupts the epidermis. Persons with psoriasis are not excluded except in cases of:

--any active lesion

--any active lesion in the previous 6 months that required treatment, either systemic or topical

--any prior episode, at any time, extensive enough or severe enough as to require systemic treatment

-Previous adverse reactions to smallpox vaccination.

-Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination or until the vaccination site heals completely: (a) children less than or equal to 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, (d) individuals with other acute, chronic, or exfoliative skin condition, or (e) immunocompromised or immunosuppressed persons (by disease or therapy).

-Participants may not be receiving any other investigational agents.

-History of allergic reactions attributed to compounds of similar chemical or biologic composition of PROSTVAC(R)

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Peter A. Pinto, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 2-5952
(240) 858-3700

Michele L. Reed (Diffenderfer), R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B2L324A
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6121

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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