An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
- Completed a full course of radiation therapy for prostate cancer at least 2 years
- Biochemical failure at screening as determined by either the ASTRO or the Phoenix
- At least 5 available PSA readings after completion of radiation therapy and prior to
- 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.
- 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
- 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.