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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Locally Recurrent Prostate Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Day 45 and Day 180

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PRX302-1-02

NCT ID:

NCT00686088

Start Date:

February 2008

Completion Date:

September 2009

Related Keywords:

  • Locally Recurrent Prostate Cancer
  • prostate cancer
  • locally recurrent
  • PRX302
  • Prostatic Neoplasms

Name

Location

Scott & White Memorial HospitalTemple,, Texas  76508
Urology San AntonioSan Antonio, Texas  78229