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Protocol Details

Prostvac in Patients with Biochemically Recurrent 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)




Recruitment Keyword(s)



Prostate Cancer

Investigational Drug(s)

PROSTVAC- V (Vaccinia)
PROSTVAC-F (Fowlpox)

Investigational Device(s)



Biological/Vaccine: PROSTVAC -V
Biological/Vaccine: PROSTVAC-F

Supporting Site

National Cancer Institute


Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer.


To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone.


Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer


Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Bone scan

CT scan, or MRI and PET scan: They lie in a machine that takes pictures of the body.

Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.

Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months.

During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months.

Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests.

Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.

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

-Biochemical progression after definitive radiation or surgery defined as follows:

--For participants following definitive therapy: a rise in PSA of greater than or equal to 2ng/mL above the nadir (per RTOG-ASTRO consensus criteria).

--For participants following radical prostatectomy: rising PSA after surgical procedure. (Participants must have a PSA greater than or equal to 0.8 ng/ml)

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

-Participants must have a PSA doubling time of 5-15 months.

-Participants must have a rising PSA as confirmed by 3 values done at least 1 week apart and over no less than 1 month.

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

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

-Hematological eligibility parameters (within 16 days before starting therapy)

--Granulocyte count greater than or equal to 1000/mm3

--Platelet count greater than or equal to 100 000/mm3

--Hgb greater than or equal to 10g/dL

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

--Hepatic function: bilirubin less than or equal to 1.5mg/dL (OR in participants with Gilbert s syndrome normal.

- 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, in the opinion of the investigator

- Willing to travel to the NIH, MSKCC, DFCI, BIDMC for follow-up visits.

- 18 years of age or older.

-Able to understand and sign informed consent.

-Baseline testosterone greater than or equal to 100 ng/dl

-PSA less than or equal to 30 ng/mL.

-The effects PROSTVAC 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, for the duration of study therapy and at least one month post therapy. 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.


-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. Participants 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


- Chronic administration (defined as daily or every other day for continued use > 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, intra-articular

injections and topical creams for small body areas is allowed.

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

-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)

- History of prior chemotherapy

- History of prior immunotherapy within the last 3 years

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

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

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

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

-Previous serious 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: Day 1 vaccination: (a) children less than or equal to 3 years of age, (b) pregnant or nursing women, (c) individuals with current or extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.

- Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugs.

-Participants who test positive for HBV or HCV

-Uncontrolled hypertension (SBP>170/ DBP>105)

-Recruitment Strategies

This study will be listed on available websites (, and participants will be recruited from the

current patient population at NIH.

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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)
National Institutes of Health
Building 10
Room 13N240B
10 Center Drive
Bethesda, Maryland 20892
(301) 480-7168

Anna C. Couvillon, C.R.N.P.
National Cancer Institute (NCI)
(240) 858-3148

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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