Status:
COMPLETED
An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
Lead Sponsor:
Sophiris Bio Corp
Conditions:
Locally Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00686088
Start Date
February 1 2008
End Date
September 1 2009
Last Update
October 29 2009
Active Locations (2)
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1
Urology San Antonio
San Antonio, Texas, United States, 78229
2
Scott & White Memorial Hospital
Temple, Texas, United States, 76508