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Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study


Phase 3
N/A
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study


OBJECTIVES:

- Compare the potential beneficial impact of radiotherapy with or without adjuvant
bicalutamide and goserelin on the long-term outcome of patients with localized prostate
cancer.

- Compare the acute and late radiation-induced side effects of these regimens in these
patients.

- Compare the biochemical/clinical disease-free survival, overall survival, and time to
local progression in patients treated with these regimens.

- Compare the time to clinical biological failure or death in patients treated with these
regimens.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs
greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated
radiotherapy once daily 5 days a week for 7-7.5 weeks.

- Arm II: Patients receive adjuvant oral bicalutamide once daily on days 1-30 and
goserelin subcutaneously on days 8 and 98. Beginning on day 8, patients undergo
radiotherapy as in arm I.

Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.

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

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this
study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage II prostate cancer

- T1b-c, N0, M0 with prostate-specific antigen (PSA) at least 10 ng/mL and/or
Gleason score at least 7 (UICC 1997 classification) OR

- T2a, N0, M0 (UICC 1997 classification)

- Serum PSA no greater than 50 ng/mL

- No involvement of pelvic lymph nodes

PATIENT CHARACTERISTICS:

Age:

- 80 and under

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No other malignancy within the past 5 years except adequately treated basal cell skin
cancer

- No psychological, familial, sociological, or geographical condition that would
preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- No prior hormonal therapy

Radiotherapy:

- No prior pelvic radiotherapy

Surgery:

- No prior radical prostatectomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter

Safety Issue:

No

Principal Investigator

Michel Bolla, MD

Investigator Affiliation:

CHU de Grenoble - Hopital de la Tronche

Authority:

United States: Federal Government

Study ID:

CDR0000068749

NCT ID:

NCT00021450

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

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