Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Hormone Therapy in Treating Patients With Advanced Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Any age Other EORTC-22961 EORTC-GU-22961, NCT00003026

Objectives

1. Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome (overall survival, clinical disease free survival, local regional control), quality of life (treatment side effects, sexual function), and health economy (cost effectiveness ratio).

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 966 patients will be accrued over 5 years.

Outline

This is a randomized, multicenter study.

Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation. Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens. Antiandrogen treatment starts 1 week before the first injection of triptorelin.

Patients are then randomized to one of two treatment arms.

• Arm I: Patients receive no further treatment.



• Arm II: Patients receive antiandrogen for 2.5 years plus and LHRH analogue (triptorelin) administered every 3 months. Patients then continue the LHRH analogue alone for an additional 2.5 years in the absence of disease progression.

Patients are followed every 6 months for 5 years and then annually thereafter.

Bolla M, van Tienhoven G, de Reijke TM, et al.: Concomitant and adjuvant androgen deprivation (ADT) with external beam irradiation (RT) for locally advanced prostate cancer: 6 months versus 3 years ADT--results of the randomized EORTC phase III trial 22961. [Abstract] J Clin Oncol 25 (Suppl 18): A-5014, 238s, 2007.

Giraud JY, Dusserre A, Conil M, et al.: Results of the dummy-run of EORTC trial no.22961: a phase III study of long term hormonal treatment on locally advanced prostatic carcinoma treated by radiation therapy and a 6 months CAB. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-699, 378, 2001.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Michel Bolla, MD, Protocol chair		Ph: 33-476-765-506 Email: mbolla@chu-grenoble.fr

European Organization for Research and Treatment of Cancer

T. de Reijke, MD, PhD, Protocol chair		Ph: 31-20-566-6004 Email: T.M.deReyke@AMC.UVA.NL

Registry Information
Official Title		Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study
Trial Start Date		1997-04-01
Registered in ClinicalTrials.gov		NCT00003026
Date Submitted to PDQ		1997-04-01
Information Last Verified		2001-10-09