A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer

Inclusion Criteria

• •1. Patients must be at least 18 years of age
• •2. Signed and dated written informed consent, obtained before the performance of any protocol-related procedure.
• •3. Histological or cytological diagnosis of prostate cancer with an elevated PSA level and radiologic evidence of metastatic disease.
• •5. Metastatic disease that has spread beyond the prostate or relapsed after local therapy, documented by body CT scan and/or bone scan, according to PCWG 3 criteria, with high volume according to criteria used in the CHAARTED study.
• •6. Radiological and scintigraphic studies to identify initial evaluable disease should be done as follows:
• •* If ADT has not been initiated, CT scans and bone scan must be obtained within 6 weeks prior to the start of ADT.
• •* If all required imaging had not been completed prior to starting ADT, any additional scan must be obtained after starting androgen deprivation but prior to randomization and the initiation of docetaxel (It is assumed that the scans of patients with high volume disease would not normalize in less than 120 days to the point that a patient would go from "high volume" to "low volume").
• •7. Measurable or evaluable disease according to the PWGC 3.
• •9. Patients receiving ADT in the adjuvant and/or neoadjuvant setting for less than 30 months of therapy, AND the effect of the last depot injection had expired at least 12 months prior to documentation of metastatic disease, AND
• •* They had no evidence of disease (PSA \< 0.2 ng/dL) after prostatectomy plus hormonal therapy, or
• +26 more criteria