Clinical trial NCT00686088: An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
Official title: An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Recurrent Prostate Cancer
Keywords: prostate cancer
locally recurrent
PRX302
Lead sponsor: Protox Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-29
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 be determined based on changes in PSA levels, PSA velocity, PSA doubling time and tumor burden following treatment.


Eligibility 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.

Primary outcomes:
measure: PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening.
timeFrame: Day 45 and Day 180
Secondary outcomes:
measure: Safety and tolerability of PRX302.
timeFrame: 12 months.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
Study officials:
References: