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Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate

Phase 1
18 Years
Not Enrolling
Prostate Cancer

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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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael J. Zelefsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




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



Memorial Sloan-Kettering Cancer Center New York, New York  10021