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

October 27, 2009 updated by: Sophiris Bio Corp
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening.
Time Frame: Day 45 and Day 180
Day 45 and Day 180

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of PRX302.
Time Frame: 12 months.
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sophiris Bio Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 26, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2009

Last Update Submitted That Met QC Criteria

October 27, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRX302-1-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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