An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy

Inclusion Criteria: * Completed a full course of radiation therapy for prostate cancer at least 2 years before enrollment. * Biochemical failure at screening as determined by either the ASTRO or the Phoenix definitions. * At least 5 available PSA readings after completion of radiation therapy and prior to screening. * PSA level of not greater than 10 ng/mL. * PSA doubling time of at least 9 months at screening. * Biopsy-proven recurrent localized prostate cancer. * Tumor stage T1C to T2C. * Prostate volume estimated at 40 mL or less as determined by TRUS. * ECOG performance score 0 to 2. * Serum testosterone of at least 1 ng/dL. Exclusion Criteria: * Prior history of metastatic prostate cancer. * Salvage external beam therapy and/or salvage brachytherapy prior to enrollment. * Biological, immunological, chemotherapeutic treatment or cryotherapy after completing radiation. * Androgen ablation therapy within 12 months prior to enrollment. * Recurrence of prostate cancer within 18 months of definitive primary radiotherapy. * Other medication for prostate cancer. * Presence of active malignancy other than prostate cancer. * Treatment with other investigational therapies within 12 months prior to enrolment. * Presence of a chronic indwelling Foley catheter for obstructive uropathy. * Previous transurethral resection of the prostate (TURP), transurethral resection of the bladder neck, photo-selective vaporization of the prostate (PVP) or other resection surgery in the urinary tract. * Previous treatment with PRX302. * Any evidence of metastatic disease on bone scan, CT or magnetic resonance imaging (MRI) within 3 months prior to enrollment.