Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with a placebo in treating patients with stage D0 prostate cancer.

Detailed Description
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OBJECTIVES: Primary To determine whether ONY-P1 vaccine can increase the time to PSA-defined progression in patients with androgen-dependent stage D0 prostate cancer. Secondary To evaluate all toxicities related to ONY-P1 vaccine. To compare the immunologic response in patients treated with ONY-P1 vaccine vs placebo. To evaluate PSA kinetics (doubling time/velocity) of treatment. To evaluate time to testosterone recovery following limited androgen ablation. OUTLINE: Patients are stratified according to estimated PSA doubling time (< 12 months vs ≥ 12 months). Patients receive goserelin subcutaneously once. Approximately 3 months later, patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically for up to 15 years.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: BCG vaccine
* Biological: prostate cancer vaccine ONY-P1
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. | Biological: BCG vaccine<br>* given intradermally<br>Biological: prostate cancer vaccine ONY-P1<br>* given intradermally<br>|
| Placebo Comparator: Arm II<br>Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. | Other: placebo<br>* given intradermally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to PSA progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Immunologic response as assessed by ELISPOT assay |  |  | 
| PSA kinetics (doubling time/velocity) of treatment |  |  | 
| Time to testosterone recovery |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV prostate cancer, recurrent prostate cancer