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

Locally Recurrent Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686088
• Other study ID #: PRX302-1-02
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2008
• Last updated: October 27, 2009
• Start date: February 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Sophiris Bio Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Recurrent Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Urology San Antonio	San Antonio	Texas
United States	Scott & White Memorial Hospital	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sophiris Bio Corp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA levels, PSA doubling time, PSA velocity and tumor burden assessment by biopsy compared to screening.		Day 45 and Day 180	No
Secondary	Safety and tolerability of PRX302.		12 months.	Yes