Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002597
First received: November 1, 1999
Last updated: June 26, 2013
Last verified: June 2013

November 1, 1999
June 26, 2013
October 1994
July 2011   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: From date of randomization to death due to any cause ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002597 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
A PHASE III TRIAL OF THE STUDY OF ENDOCRINE THERAPY USED AS A CYTOREDUCTIVE AND CYTOSTATIC AGENT PRIOR TO RADIATION THERAPY IN GOOD PROGNOSIS LOCALLY CONFINED ADENOCARCINOMA OF THE PROSTATE

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.

OBJECTIVES: I. Compare the overall and disease-specific survival and local and/or distant clinical relapse rate in patients with locally confined carcinoma of the prostate treated with goserelin plus flutamide used as cytoreductive agents prior to definitive radiotherapy vs radiotherapy alone. II. Compare these regimens in terms of freedom from prostate specific antigen (PSA) failure, second clinical relapse, and second PSA relapse in these patients. III. Compare prostate rebiopsy results in these patients at 2 years. IV. Determine the effect of goserelin and flutamide therapy on sexual function in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by PSA level (less than 4 vs 4-20), tumor differentiation (good vs moderate vs poor), nodal status (N0 vs Nx), and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral flutamide 3 times a day and goserelin subcutaneously once every 4 weeks, or once as a time release injection (intramuscular leuprolide may be substituted for goserelin), beginning 2 months prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy daily 4-5 days per week for almost 8 weeks. Arm II: Patients undergo radiotherapy only, as in arm I. Patients are followed every 3 months for the remainder of the first year, every 4 months for 1 year, every 6 months for 3 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1980 patients will be accrued for this study within 5 years.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: flutamide
  • Drug: goserelin acetate
  • Drug: leuprolide acetate
  • Radiation: radiation therapy
  • Experimental: Neoadjuvant TAS 2 months before and during RT
    Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
    Interventions:
    • Drug: flutamide
    • Drug: goserelin acetate
    • Drug: leuprolide acetate
    • Radiation: radiation therapy
  • Radiation therapy alone
    Radiation therapy alone
    Intervention: Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2028
Not Provided
July 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Clinical stage T1b/1c/2a/2b, Nx or N0, M0 disease (stage I or II) Nodes considered negative by imaging methods classified as Nx; those considered negative by surgical sampling classified as N0 PSA no greater than 20

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Alanine aminotransferase (ALT) no greater than 2 times upper limit of normal Renal: Not specified Other: No major medical or psychiatric illness that would prevent compliance No other malignancy in the past 5 years except basal or squamous cell skin carcinoma (a minimum of 2 years since squamous cell carcinoma)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 60 days since prior finasteride for prostate hypertrophy At least 90 days since prior testosterone No other prior hormonal therapy Radiotherapy: No prior radiotherapy Surgery: No prior radical surgery or cryosurgery for carcinoma of the prostate

Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00002597
RTOG-9408, CDR0000063821
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: David G. McGowan, MD Cross Cancer Institute at University of Alberta
Radiation Therapy Oncology Group
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP