Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Radiation: low-LET photon therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00002511

EORTC-22911

EORTC-GU-22911

Details and patient eligibility

About

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

PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy.

Full description

OBJECTIVES:

• Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse.
• Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease.

OUTLINE: This is a randomized study.

• Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks.
• Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy.

Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter.

PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years.

Enrollment: 1,005 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically documented invasive adenocarcinoma of the prostate staged pT3 pN0 after radical prostatectomy

  • Preoperative staging must have been T0-3 N0 M0 based on physical exam, chest x-ray, bone scan, CT or MRI of entire pelvis and abdomen, and serum PSA

  • At least 1 of the following features must be present:

    • Complete capsule invasion (i.e., perforation)
    • Positive surgical margins (microscopic or gross)
    • Seminal vesicle invasion

• Radiotherapy must begin within 16 weeks following surgery, after recovery of urinary function

PATIENT CHARACTERISTICS:

Age:

• 75 and under

Performance status:

• WHO 0-2

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other malignancies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No more than 4 months of preoperative hormonal therapy

Radiotherapy:

• Not specified

Surgery:

• Radical prostatectomy required within 12 weeks with recovery of urinary function