Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate
OBJECTIVES: I. Determine the maximum tolerated dose of radiotherapy using 3-dimensional (3D)
conformal techniques in patients with stage II or III adenocarcinoma of the prostate. II.
Determine the morbidity of high-dose 3D conformal therapy in these patients.
OUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal
radiotherapy 4-5 days a week for at least 8 weeks. Cohorts of 20-40 patients receive
escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose at which no more than 10% of patients experience dose-limiting
toxicity. Patients are followed at 3 months, every 6 months for 5 years, and then annually
thereafter.
PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Locally advanced (T2c-T3) adenocarcinoma of the prostate
including: Bulky tumors confined to prostate (stage II) Tumors extending beyond capsule
(stage III) PSA no greater than 20 ng/mL No regional lymph node involvement (by CT scan or
surgical sampling) No distant metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater
than 100,000/mm3 Hemoglobin greater than 11 g/dL Hepatic: Not specified Renal: Not
specified Other: No major medical or psychiatric illness that would preclude study No
metallic pelvic prosthesis
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No
prior radiotherapy (including pelvic irradiation) Surgery: No prior radical surgery for
carcinoma of the prostate
Type of Study:
Interventional
Study Design:
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:
91-022
NCT ID:
NCT00002480
Start Date:
February 1991
Completion Date:
August 2005
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
