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.