Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer

Launched by NCIC CLINICAL TRIALS GROUP · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Compare the overall survival, disease specific survival, and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation.
* Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease (e.g., transurethral resections, stent insertions, nephrostomies, and colostomies) in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
* Compare the sensitivity of the EORTC-QLQ-C...

Gender

MALE

Eligibility criteria

• DISEASE CHARACTERISTICS:
• * Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following:
• • T3-4, N0 or NX, M0
• • T2, PSA greater than 40 µg/L
• • T2, PSA greater than 20 µg/L AND Gleason score at least 8
• • Diagnosis made within the past 6 months
• • Gleason score and PSA known
• • Pelvic lymph nodes must be clinically negative
• • Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis
• • Negative needle aspirate required for any lymph node more than 1.5 cm
• • If a lymph node dissection was performed, it must be histologically negative
• • No small cell or transitional cell carcinoma by biopsy
• • No bony metastases by bone scan
• PATIENT CHARACTERISTICS:
• Age:
• • Under 80
• Performance status:
• • ECOG 0-2
• Life expectancy:
• • At least 5 years excluding malignancy
• Hematopoietic:
• • Hemoglobin at least 10.0 g/dL
• • WBC at least 2,000/mm\^3
• • Platelet count at least 100,000/mm\^3
• Hepatic:
• • Bilirubin less than 2 times upper limit of normal (ULN)
• • SGOT and SGPT less than 2 times ULN
• • Alkaline phosphatase less than 2 times ULN
• • No history of chronic liver disease
• Renal:
• • Creatinine less than 2 times ULN
• Other:
• • No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability)
• • No other malignancy within the past 5 years except nonmelanoma skin cancer
• • Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • Not specified
• Chemotherapy:
• • Not specified
• Endocrine therapy:
• * Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met:
• • Negative bone scan before beginning any hormonal therapy
• • Extracapsular extension remains palpable on rectal re-exam
• • Baseline PSA known before beginning any hormonal therapy
• • At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy
• Radiotherapy:
• • No prior pelvic irradiation
• Surgery:
• • No prior radical prostatectomy
• • Prior transurethral resection of the prostate allowed
• Other:
• • No prior cytotoxic anticancer therapy
• • No other prior treatment for prostate cancer
• • No other concurrent anticancer therapy unless documented disease progression

Trial Officials