Skip to main content
OpenTrials
Completed

NCT Number: NCT00104741

Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

0 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Clinique De Rochebelle, Alès, France

Loading trial locations.

About this study

OBJECTIVES:

  • Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer.
  • Compare the survival rate, in terms of 5-year clinical or biological remission, in patients treated with these regimens.
  • Compare overall survival in patients treated with these regimens.
  • Compare acute and late toxicity of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.
  • Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo conformal external beam radiotherapy.
  • Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily. Androgen blockade therapy continues for a total of 4 months. Two months after initiation of androgen blockade therapy, patients undergo conformal external beam radiotherapy.

Quality of life is assessed.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer, meeting the following clinical staging criteria:
  • Stage T1b-T1c AND prostate specific antigen (PSA) ≥ 10 ng/mL OR Stage T1b-T1c AND Gleason score ≥ 7 OR Stage T2a-T3a
  • No lymph node invasion (N0 or N-)
  • Patients with ≥ 10% risk by the Partin table must undergo curage
  • No metastatic disease (M0) by thoracic radiography and bone scan
  • PSA < 30 ng/mL
  • No history of invasive cancer

PATIENT CHARACTERISTICS:

Age

  • Under 75

Performance status

  • ECOG 0-1

Life expectancy

  • At least 10 years

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

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
  • No prior castration

Treatment and study plan

flutamide

Drug

Triptorelin

Drug

radiation therapy

Radiation

Primary outcomes

  1. Impact of complete androgen blockade for 4 months

  2. Survival, in terms of clinical or biological remission, at 5 years

  3. Overall survival

  4. Acute and late toxicity

  5. Quality of life

  6. Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Registry information

Official study title

Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis

Important dates

Study start
2003
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2005
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.