Hormone Therapy in Treating Patients With Advanced Prostate Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens.

PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Bicalutamide; Flutamide; Triptorelin Pamoate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• T1c-T2a-b, N1-2 or pN1-2 (after pelvic lymphadenectomy)

• T2c-T4, N0-2

• Prior external radiotherapy for locally advanced prostatic carcinoma required

• Prior hormone therapy (6 months of combined androgen blockade) for locally advanced prostatic carcinoma required with PSA no greater than 150 ng/mL before administration

• No progressive disease after the 6 months of combined androgen blockage

• No stages T1c/T2a-b with a negative pelvic lymph nodes status that is assessed clinically or surgically

• No lymph node involvement to common iliac and/or periaortic lymph nodes (M1a)

• No external iliac lymph node metastasis more than 5 cm in greatest dimension (N3)

• No distant metastases

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• WHO 0-2

Life expectancy:

• At least 5 years

Hematopoietic:

• Hemoglobin at least 10 g/dL

• WBC at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No prior or concurrent cancers other than basal cell skin cancer

• No serious nonmalignant disease resulting in a life expectancy of less than 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for prostate cancer

Chemotherapy

• No prior chemotherapy for prostate cancer

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics