Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasm
Male
Prostatic Neoplasm
Trial Information
Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer
Inclusion Criteria:
- Patients with pathologically proven prostate cancer
- No evidence of distant metastases (M0) on physical examination, bone scan
- ECOG PS 0,1,2
- Adequate organ function as evidenced by:
- Hemoglobin > 10.0 gm/dl
- White blood count > 3000/mcL
- Platelet count > 90,000/mcL
- AST < 2x normal
- Age > 18 years
- Patients can not be allergic to Leuprolide or Goserelin if the pretreatment PSA > 20,
Gleason Score > 8, T3/4, or N1 disease
- Written informed consent
- We anticipate enrolling at least 50 patients per year, which would bring accrual to
projected total of 100 patients in 2 years
Exclusion Criteria:
- None
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary outcome will be assessment of toxicity as well as efficacy as determined by survival rates, freedom from biochemical relapse rates, local control rates, distant failure rates.
Authority:
United States: Institutional Review Board
Study ID:
390-02
NCT ID:
NCT00956228
Start Date:
October 2006
Completion Date:
December 2007
Related Keywords:
- Prostatic Neoplasm
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Scottsdale, Arizona |
