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

NCT00686088 | Completed Phase 2

• 1 other identifier: PRX302-1-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Locally Recurrent Prostate Cancer

Keywords

prostate cancer; locally recurrent; PRX302

Outcome Measures

Primary Outcomes (1)

• PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening.

  Day 45 and Day 180

Secondary Outcomes (1)

• Safety and tolerability of PRX302.

  12 months.

Interventions

PRX302 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sophiris Bio Corp: lead

Study Sites (2)

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PRX302

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2008
• First Posted: May 29, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 29, 2009

Record last verified: 2009-09

Locations

US (2)