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.

First Received on May 26, 2008. Last Updated on October 27, 2009 History of Changes

Sponsor:	Protox Therapeutics
Information provided by:	Protox Therapeutics
ClinicalTrials.gov Identifier:	NCT00686088

Purpose

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	Intervention	Phase
Locally Recurrent Prostate Cancer	Drug: PRX302	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Protox Therapeutics:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Safety and tolerability of PRX302. [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Determination of the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686088

Locations

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

Sponsors and Collaborators

Protox Therapeutics

More Information

No publications provided

Responsible Party:	Rosemina Merchant, M.E.Sc., VP, Development and Regulatory Affairs, Protox Therapeutics
ClinicalTrials.gov Identifier:	NCT00686088 History of Changes
Other Study ID Numbers:	PRX302-1-02
Study First Received:	May 26, 2008
Last Updated:	October 27, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Protox Therapeutics:

prostate cancer
locally recurrent
PRX302

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012