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


Phase 3
N/A
N/A
Not Enrolling
Both
Prostate Cancer

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Trial Information

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


OBJECTIVES:

- 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).

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.

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michel Bolla, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CHU de Grenoble - Hopital de la Tronche

Authority:

United States: Federal Government

Study ID:

EORTC-22961

NCT ID:

NCT00003026

Start Date:

April 1997

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

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