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

This study has been completed.

Sponsor:

Information provided by:

Sophiris Bio Corp

ClinicalTrials.gov Identifier:

NCT00686088

First received: May 26, 2008

Last updated: October 27, 2009

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	May 26, 2008
Last Updated Date	October 27, 2009
Start Date ^ICMJE	February 2008
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 28, 2008)	PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening. [ Time Frame: Day 45 and Day 180 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00686088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 28, 2008)	Safety and tolerability of PRX302. [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
Official Title ^ICMJE	An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Locally Recurrent Prostate Cancer
Intervention ^ICMJE	Drug: PRX302 Determination of the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	30
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00686088
Other Study ID Numbers ^ICMJE	PRX302-1-02
Has Data Monitoring Committee	No
Responsible Party	Rosemina Merchant, M.E.Sc., VP, Development and Regulatory Affairs, Protox Therapeutics
Study Sponsor ^ICMJE	Sophiris Bio Corp
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sophiris Bio Corp
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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