A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histopathological documentation of prostate cancer

- If no pathologic specimen is available, patients may enroll on study with a
pathologist's report showing a histologic diagnosis of prostate cancer and a
clinical course consistent with the disease

- Biochemical progression, as defined by the following:

- A rise in PSA of ≥ 2 ng/mL above the nadir (for patients previously treated with
definitive radiotherapy or cryotherapy)

- Two consecutive rises in PSA > 0.3 ng/mL (for patients previously treated with
radical prostatectomy)

- PSA ≤ 20 ng/mL

- Testosterone ≥ lower limit of normal

- Negative CT scan and bone scan for metastatic prostate cancer

- No clinically active brain metastases

PATIENT CHARACTERISTICS:

- ECOG performance status of 0-1

- Life expectancy ≥ 6 months

- Granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Bilirubin ≤ 1.5 mg/dL OR total bilirubin ≤ 3.0 mg/dL (in patients with Gilbert's
syndrome)

- AST and ALT ≤ 2.5 times upper limit of normal

- No other active malignancies within the past 60 months (with the exception of
nonmelanoma skin cancer or carcinoma in situ of the bladder)

- No life-threatening illnesses

- No immunocompromised status due to any of the following:

- HIV positivity

- Active autoimmune diseases, such as Addison's disease, Hashimoto's thyroiditis,
systemic lupus erythematosus, Sjögren 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, or gastrointestinal tract, will
be allowed

- Other immunodeficiency diseases or iatrogenic immunodeficiency from drugs

- No other serious medical illness that would interfere with the patient's ability to
carry out the treatment program

- No documented contraindication (allergy or severe reaction to BCG)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from all prior therapy, including surgery and radiotherapy (no toxicity ≥
grade 2)

- No prior chemotherapy

- No concurrent topical steroids (including steroid eye drops) or systemic steroids

- Nasal or inhaled steroid use is permitted

- No concurrent medications used for urinary symptoms, including 5-alpha reductase
inhibitors (finasteride and dutasteride)

- No concurrent alternative medications known to alter PSA (e.g., phytoestrogens or saw
palmetto)

- No other concurrent hormonal therapy

- No other concurrent anticancer treatment, including chemotherapy, systemic
glucocorticoids, radiotherapy, major surgical procedures for prostate cancer, or
nonprotocol-related immunotherapy