PSA-Activated PSA-PAH1 for Locally Recurrent Prostate Cancer

Inclusion Criteria

• •18 years of age or older
• •Histologically proven prostate adenocarcinoma
• •Completed a full course of definitive external beam radiation or definitive brachytherapy (but not both) as primary therapy for diagnosed prostate cancer at least one year prior to enrollment
• •Subject must have at least one available PSA measurement that was taken 60 days or more following their primary therapy, but no later than 2 months prior to their screening visit (this measurement will serve as the first time point for computing a screening value for PSA doubling time)
• •Subject's PSA doubling time at screening must be \> 3 months (this doubling time will be computed by comparing the earliest available PSA that is 60 days or more following the subject's primary therapy but no later than 2 months prior to their screening visit, to the PSA measurement obtained during the screening visit)
• •Within one year prior to enrollment:
• •* Demonstrated "biochemical failure," as determined by three consecutive increases in PSA at least 2 weeks apart
• •* Multiple-site biopsy-confirmed local recurrence of prostate cancer
• •Within 3 months prior to enrollment:
• •* No evidence of metastatic disease including no bone metastases on bone scan, or any lymph node, lung, liver or soft tissue metastases on a CT or MRI scan or any other evidence of metastatic disease
• •* No receipt of androgen ablation therapy \[Note: Subjects may have received androgen ablation therapy in the past, but not within 3 months prior to enrollment. No subject will be removed from androgen ablation therapy prior to this trial to permit/facilitate eligibility for this trial.\]
• •Within 30 days prior to enrollment:
• •* Prostate gland weighing less than 40 g estimated on the basis of CT/ultrasound data
• •* Serum testosterone above castrate range (\> 1 ng/dL)
• •* PSA level less than 20 ng/mL
• •* Eastern Cooperative Oncology Group (ECOG) score of 0-2
• •* Written informed consent
• •* Adequate organ function as evidenced by: