A Phase II Study Using High Dose Three Dimensional Conformal Radiation Therapy in Intermediate Prognostic Risk Patients With Adenocarcinoma of the Prostate
N/A
N/A
Male
Prostate Cancer
Trial Information
A Phase II Study Using High Dose Three Dimensional Conformal Radiation Therapy in Intermediate Prognostic Risk Patients With Adenocarcinoma of the Prostate
OBJECTIVES:
- Establish the efficacy of high-dose three-dimensional conformal radiotherapy in
patients with intermediate prognostic risk adenocarcinoma of the prostate.
- Determine the PSA relapse-free survival rate of this patient population.
OUTLINE: Patients receive high-dose three-dimensional conformal radiotherapy 4-5 days per
week for at least 9 weeks.
Patients are evaluated at least weekly during radiotherapy and at 2 and 4 months after
treatment completion. Thereafter, patients are followed every 6 months for a total of 3
years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven intermediate prognostic risk (T1-T2) adenocarcinoma of the
prostate
- Previously untreated (except for hormonal therapy)
- PSA levels greater than 10 ng/mL and Gleason scores no greater than 6 OR
- PSA levels no greater than 10 ng/mL and Gleason scores at least 7
- Patients requiring volume reduction of prostate prior to radiotherapy continue
to be treated at least 3 months on neoadjuvant hormonal therapy prior to
radiation
- No evidence of distant metastases
- No regional lymph node involvement
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No major medical illness
- No psychosis
- No metallic pelvic prosthesis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
- Prior neoadjuvant antiandrogen therapy allowed
Radiotherapy:
- No prior radiotherapy
- No prior pelvic irradiation
Surgery:
- No prior radical surgery for carcinoma of the prostate
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Michael J. Zelefsky, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
97-064
NCT ID:
NCT00003104
Start Date:
June 1997
Completion Date:
October 2005
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
