NCT00002602

Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer

Study Contact:

Study Phase:

PHASE1

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00002602

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have previously untreated stage II or stage III prostate cancer.

Eligibility

DISEASE CHARACTERISTICS: Previously untreated adenocarcinoma of the prostate T1b-c or T2a-b with a Gleason score more than 5 and PSA greater than 4 ng/mL OR Any T3 PSA under 70 ng/mL within 3 weeks prior to entry and at least 10 days after prostate biopsy No biopsy proven regional nodal involvement No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Hematopoietic: White blood cell (WBC) count of at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior pelvic irradiation Surgery: No prior prostatectomy or cryosurgery for prostate cancer

Disease(s) and\or Condition(s)

Prostate Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: RADIATION
- Name: 3D-CRT
- Description: 3 dimensional conformal radiation therapy
- Arm Group Labels: Group 1, Group 2, Group 3

Sponsor

Radiation Therapy Oncology Group