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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00686088
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : October 29, 2009
Sponsor:
Information provided by:
Protox Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Locally Recurrent Prostate Cancer Drug: PRX302 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Intervention Details:
  • Drug: PRX302
    Determination of the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate.

Outcome Measures
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Primary Outcome Measures :
  1. PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening. [ Time Frame: Day 45 and Day 180 ]

Secondary Outcome Measures :
  1. Safety and tolerability of PRX302. [ Time Frame: 12 months. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686088


Locations
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United States, Texas
Urology San Antonio
San Antonio, Texas, United States, 78229
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
Sponsors and Collaborators
Sophiris Bio Corp
More Information
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Responsible Party: Rosemina Merchant, M.E.Sc., VP, Development and Regulatory Affairs, Protox Therapeutics
ClinicalTrials.gov Identifier: NCT00686088    
Other Study ID Numbers: PRX302-1-02
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: September 2009
Keywords provided by Protox Inc.:
prostate cancer
locally recurrent
PRX302
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases