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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate. Therapeutic activity will be determined based on changes in PSA levels, PSA velocity, PSA doubling time and tumor burden following treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sophiris Bio Corp

Criteria

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.