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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: flutamide
Drug: goserelin acetate
Drug: leuprolide acetate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From date of randomization to death due to any cause ] [ Designated as safety issue: No ]

Enrollment: 2028
Study Start Date: October 1994
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant TAS 2 months before and during RT
Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate Radiation: radiation therapy
Radiation therapy alone
Radiation therapy alone
Radiation: radiation therapy

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002597

  Show 239 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: David G. McGowan, MD Cross Cancer Institute at University of Alberta
  More Information

Additional Information:
Publications:
McGowan D, Hunt D, Jones C, et al.: Effect of short-term endocrine therapy prior to and during radiation therapy on overall survival in patients with T1b-T2b adenocarcinoma of the prostate and PSA equal to or less than 20: initial results of RTOG 94-08. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-6, 2010.
Bruner D, Scott C, McGowan D, et al.: Factors influencing sexual outcomes in prostate cancer patients enrolled on radiation therapy oncology group studies 90-20 and 94-08. [Abstract] Proceedings of the International Society for Quality of Life Research 7: 575, 1998.
Bruner DW, Scott CB, McGowan D, et al.: Validation of the sexual adjustment questionnaire (SAQ) in prostate cancer patients enrolled on Radiation Therapy Oncology Group studies 90-20 and 94-08. [Abstract] Int J Radiat Oncol Biol Phys 42 (suppl 1): A-156, 202, 1998.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002597     History of Changes
Other Study ID Numbers: RTOG-9408, CDR0000063821
Study First Received: November 1, 1999
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Flutamide
Leuprolide
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 23, 2014